Medical Device - Eventura

This 90 minute Webinar will cover the concepts of measurement, analysis, and improvement to ensure conformity of products, conformity of the management system, and on-going effectiveness. This webinar includes strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. An effective yet efficient quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This webinar will get you started in setting up just such a Quality System. We’ll discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS. In this webinar, we will discuss: – Regulatory Expectations – Common problems and lessons from 483 and warning letters – Red-flags that your QS is not effective – Measurement and metrics – Feedback, Complaint Handling, Internal Audit – Analysis of data – Risk based thinking – Improvement and your CAPA process – Management Review Why You Should Attend: This webinar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient. You’ll learn to recognize sources of ineffectiveness and inefficiency in your QMS. This webinar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters! The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with over 30 years’ experience in medical devices. Learning Objectives: Quality System Expectations Characteristics of an effective QMS Characteristics of an efficient QMS Roles, responsibilities, capabilities Red Flags and warning signs Improvement tools and techniques Inspection preparedness and management Best Practices Areas Covered in the Session : Establishing P&PC Change Control Environmental Control Personnel Requirements Contamination Control Buildings Equipment Manufacturing Material Automated Processes Inspection, Measuring, and Test Equipment Process Validation Linkages to the total product life cycle and risk management Process Improvement Who Should Attend: Quality Systems Specialists Document Control Specialists Quality and Compliance Specialists Auditors Auditor Managers Compliance Managers Quality Managers CAPA Specialists Quality and Compliance directors for Medical Device companies General Managers and Executives wanting to use Compliance and Quality as a competitive strength

$348

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ISO 14971:2019 Medical Device Hazards and Risk Management – All you need to know

Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while increasing user benefits. What “risk” is to be analyzed? One of the best tools to achieve and document this is ISO 14971 for devices. Recently ISO 14971 was changed. The 2019 version is replacing the 2014. What does that mean for medical device designers, specification developers, manufacturers, QA and RA? How should the change be managed? Common considerations: Many cGMP activities must be “Risk-Based”. What does that mean; what does it not mean? – An important distinction, which, when neglected, has resulted in several Warning Letters from the US FDA. How does ISO 14971 address risk-based. How is it mandated to be used in software verification and validation. How does it impact CAPA / NCMR / Complaint investigations. Many firms use some product risk management tools, but are not compliant to ISO 14971 in any version, for devices. What changes would be necessary to become compliant? What are Europe and U.S. regulatory expectations? What benefits beside regulatory compliance can be achieved for a company? Why You Should Attend: In this important webinar, see the elements recommended or expected to be in the Risk Management File / Report. Learn how to blend ISO 14971 into a company’s cGMP system, which is a requirement of regulatory agencies. What should be the areas of focus. Make the document a “living” document. Achieve major business benefits by regular use of the Risk Management File / Report in training, marketing, validation, root cause analysis, CAPA activities and failure investigations, as well as the obvious, increased product safety and reduced liability. Areas Covered in the Session : The Changes; Timelines Key Requirements of ISO 14971 Suggested formats Expected sources of information to evaluate What to include How to complete, document, and control Areas of contraversy An often neglected safety feature A “living” useful, cost-saving document Is it being used to its full business benefit? Who Should Attend: Quality Assurance Departments Research and Development Departments Regulatory Affairs Departments Manufacturing Departments Engineering Departments Operations Departments Production Departments Validation Departments Documentation Departments Consultants

$350

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Statistical Justification for Sample Size and the Use of Only 3 Lots for Process Validation

Almost all manufacturing and development companies perform at least some process validation studies, but it is difficult to decide how many Lots to include in the study and how large the Sample per Lot should be. This webinar provides a “statistical” justification and method for determining Sample Sizes, and a statistical justification for using only 3 Lots (which is the typical number, especially in industries regulated by the FDA). Those justifications can then be documented in Protocols or regulatory submissions, or can be given to regulatory auditors who may ask for them during onsite audits at your company. Thus, this webinar is designed to help you avoid regulatory delays in product approvals and to prevent an auditor from issuing you a nonconformity. This webinar does not address clinical trials, nor bulk-solution processes. It applies to unitized products such as pills, drug-filled syringes, medical devices, and components. Areas Covered in the Session : This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies. The statistical methods discussed during the webinar include the following: Confidence intervals Confidence / Reliability Calculations (for variables & attributes) It then explains how to analyze those samples in such a way that they provide statistically valid final %Reliability for the production Process itself. One example is worked through completely. Topics include: Introduction: Regulatory requirements Basic concepts and vocabulary Calculation of Sample Size to be taken from each Lot in the Validation study Calculation of % Confidence and %Reliability ( = %-in-specification) for each Lot Calculation of % confidence and %Reliability for the Production Process Worked example (with all calculations) Example summary “justification” statement Access to instructor’s website, for downloading free relevant statistical software Who Should Attend: Research and Development Departments Quality Assurance Departments Quality Control Departments Manufacturing Departments Engineering Departments

$350

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How to Prepare for and Host a FDA Inspection and Respond to 483’s

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters. FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483’s than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter. Areas Covered in the Session : Personnel Preparation Facility Needed to Support Inspection Behavior During Inspection-what not to Sign Internal/ Mock Audits 483 Response Who Should Attend: Quality Departments Regulatory Affairs Departments Manufacturing Departments Engineering Departments Corporate Management Division Management

$553

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Avoid Reporting Cybersecurity Updates and Patches to the FDA

Is a cybersecurity patch or update a reportable event under the Reports of Corrections and Removals regulation? (21 CFR Part 806) The FDA issued a guidance document recently entitled, “Postmarket Management of Cybersecurity in Medical Devices.” It explains that a patch or update to correct and/or prevent a cybersecurity breach or weakness does not necessarily require a report under Part 806. Whether the District Office recall coordinators still expect a report is not addressed. The ONC established the Information Sharing Analysis Organization (ISAO) that provides a forum for manufacturers to voluntarily participate in what could be seen as a self-help group. Participation in the ISAO gives you a pass on reporting under Part 806. Why? The FDA cannot address the overwhelming volume and aggressive evolution of cybersecurity problems with medical devices. Sadly, the problems involve more than devices themselves, it cascades into bad publicity and patients become alarmed due to the publicity of cybersecurity attacks. The problem is not limited to devices alone, healthcare facilities find their software systems are held ransom until they pay for a restoration, a coercive extortion. Without institutional software, current medical care procedures grind back to a manual program, much like a flashback to SOPs in the 1950s. Patients on life support and life sustaining devices are placed in immediate danger. The National Institute of Standards and Technology (NIST) is trying to make headway in providing guidance on how to manage these kinds of issues that plague devices and health care organizations. Neither you nor the FDA can keep up with preventative measures. Hackers are ahead of the game. The webinar will address how the federal government is creating a forum for manufacturers to share information and their experiences concerning cybersecurity. Maybe reporting a patch or update under Part 806 is an acceptable cost for not participating in the ISAO program. There are issues lurking behind the use of the ISAO forum. Make sure you consider the issues that are included in this webinar. Areas Covered in the Session : FDA Guidance and Strategy Industry wide approach Regulatory relief from required reports Management of Health Information National Institute of Standards and Technology Cybersecurity guidelines Business risks vs. benefits for application interface programs (AIP) Hospital extortion FBI warning to the medical device industry Who Will Benefit: Regulatory Affairs Departments Quality Assurance Departments Software Design Engineers Manufacturing Departments Compliant Departments Hospital Risk Departments Software Program Marketers IT Security Departments Marketing Departments Home Healthcare Services Healthcare Information Protection Departments Capital Venture Firms Medical Device Consultants

$370

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Auditing Laboratory Data Systems

The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with laboratory computer systems with an understanding of the controls that are necessary to ensure the integrity of analytical data. The webinar will teach participants the importance of correct data system configuration and what to look for during the audit. Businesses will benefit by reducing the risk of regulatory action as a result of failure to comply with current expectations. Areas Covered in the Session : Categories of laboratory data system (GAMP) Lifecycle management, archiving and backup What counts as raw data? Protecting the integrity of analytical data General guidance on assigning user privileges Operating system configuration. Application configuration Controls appropriate for chromatography data systems Practices that aid compliance with data integrity requirements Examples from recent FDA warning letters Who Should Attend: Staff who are required to audit analytical operations who do not have a chemical QC background Auditors who require updating on current regulatory expectations QC staff who needs help in regulatory compliance Staff who would like to understand the implications of data integrity for laboratory data systems

$350

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Assay Validation For Clinical Diagnostics

This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use. On a regular basis, there are assays that get developed that have a clear utility in the clinic. However, what may be practical within a research context may not be practical within a clinical context. In addition, these assays have to be able to handle clinically relevant samples, which often differ from the samples used in research studies. Unless an assay can give clinically actionable results in a clinical laboratory, whatever utility the assay may have will be useless to clinical practitioners, who have different demands than research laboratories. Why You Should Attend: In this 60-minute training, you will be able to learn what needs to be done to an assay to make sure it is ready for the clinic and how to validate such changes. In addition, you will learn how to select a clinically relevant population for a given assay, validate the assay within such a population and how to select Gold Standards for comparison. Finally, you will be able to develop clinical quality monitoring standards to make sure the assay remains relevant in a clinical context. Areas Covered in the Session : What are the key differences between a research assay and a clinical assay How to make sure an assay can regularly be performed by a medical technologist and how to validate those changes How do you find clinical relevant samples to test your assay against How to find a Gold Standard Assay and develop a validation plan against it How to validate an assay for clinical use How to develop a clinical quality plan to make sure the assay remains valid Who Should Attend: Senior Management Quality Assurance Research and Development Medical Technologists Scientists Regulatory Affairs Validation Specialists All Personnel who perform, supervise, manage, audit or oversee the validation of assays in a laboratory

$338

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Applying Computer System Validation to Mobile Applications

Mobile applications can be validated as per FDA regulations using the same principles of computer system validation. For this to be compliant, development of an appropriate validation strategy to achieve the diligence required to prove that a system does what it is meant for is essential. This will help ensure that the application is maintained in a validated state throughout its entire life cycle, from conception through retirement. If you are engaged in working on any mobile application that comes under the purview of the FDA; including but not limited to planning, executing, implementation or even if its providing support and maintenance services; this webinar will be exceedingly valuable. This webinar will help you understand and stay up to date on key best practices that deliver results while focusing on the most critical and cost-effective methods, techniques and tools available. Joining the webinar will help you learn how to use the best practices across all systems in accordance with FDA requirements and create a standardized program by applying SDLC methodologies to mobile applications. Areas Covered in the Session : When validating how should mobile applications be handled Best practices for maintaining a mobile application in a validated state Discuss the best practices necessary to ensure all systems, including mobile applications, are validated appropriately Learn how to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge Understand some of the key “pitfalls” to avoid when applying the concepts of computer system validation to mobile applications Who Should Attend: This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include: Information Technology Analysts Information Technology Developers and Testers QC/QA Managers and Analysts Clinical Data Managers and Scientists Analytical Chemists Compliance and Audit Managers Laboratory Managers Automation Analysts Computer System Validation Specialists GMP Training Specialists Business Stakeholders/Subject Matter Experts Business System/Application Testers

$350

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21 CFR Part 11 Compliance for Electronic Records and Signatures

Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will explain what all this means. The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained. Why You Should Attend: This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both. You will also receive a 21 CFR checklist and a Test protocol form as handouts. Areas Covered in the Session : Origin of the regulation and changes in Interpretation Electronic Records Electronic Signatures Data Security Open, closed and hybrid Systems Validation Methods Risk Analysis Who Should Attend: Quality Assurance Departments Regulatory Affairs Departments Engineering Departments IT Departments Validation Departments Documentation Departments

$350

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10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love

For a number of years now there has been an increasingly number of CGMP violations involving data integrity during CGMP inspections as observed by the FDA. One of the most important responsibilities of the industry is to ensure data integrity is implemented. Data Integrity verification ensures the safety, efficacy, and the quality of drugs as per cGMP standards for biologics and medical devices. These CGMP violations have generated serious concern have led to numerous regulatory actions which have included warning letters, 483 observations, import alerts, and consent decrees. All of our webinar attendees will achieve a comprehensive understanding of FDA’s regulatory expectations for Data Integrity. Attendees will obtain the know-how and the confidence to review practices at their own site and identify gaps in their own practices. Areas Covered in the Session : Comprehend the current regulatory position on data integrity Ascertain the criteria for data integrity Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory Learn about approaches to improve data integrity in a laboratory environment 21 CFR Part 11 compliance FDA citations related to data integrity issues Who Should Attend: Site Quality Operations Managers Quality Assurance personnel Plant Managers and Supervisors Manufacturing Superintendents and Managers Regulatory Affairs Managers

$350

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510(k) and PMA Refuse to Accept Policy

This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability criteria for each 510(k) – Traditional, Abbreviated, and Special. The checklists clarify the content needed in traditional, special, and abbreviated 510(k) submissions to allow FDA to conduct a substantive review, thereby enhancing the quality of received 510(k) submissions and improving overall review time. The Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) contains other critically important checklists that cover the acceptance review criteria for PMAs. This document also addresses medical device products which include drug components. The guidance outlines new requirements direct registrants to include drug patent information as well as any exclusive marketing rights that may cover a combination product’s drug component. The FDA requires this information as a factor in determining whether applications are complete and can proceed to more in-depth reviews. Learning Objectives: List and describe the contents of the Refuse to accept 510 (k) and Acceptance and Filing Reviews for Premarket Approval Applications Guidance Documents Identify the critical components of each Guidance Document List and describe the five preliminary questions that are identified in the Refuse to Accept for 510 (k) document List and describe the contents application of the checklists contained in each guidance document Areas Covered in the Session : Refuse to Accept for 510(k) – Guidance overview – Acceptance review timing – Five preliminary questions – Checklist review Acceptance and Filing Reviews for Premarket Approval Applications (PMA)s – Guidance overview – Grounds for refusing to accept an application – Combination product administrative items – Checklist Who Should Attend: Quality Departments Regulatory Affairs Departments Manufacturing Departments Engineering Departments Compliance Departments Marketing Departments Documentation Departments

$350

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510(k) Third Party Review Program – Latest Guidance, Changes, Challenges, and Opportunities

This webinar will examine the FDA’s latest draft guidance, “510(k) Third Party Review Program, Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” and the important areas for regulated companies to focus in the coming year onward. The 510(k) Third Party (3P) Review Program (formally known as the Accredited Persons (AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Under this authority, FDA recognizes third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices. This establishes a process for recognition of qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible for review under the 3P Review Program. This webinar will also discuss amendments made to section 523 by the FDA Reauthorization Act of 2017, which directed FDA to issue draft guidance on the factors that are used to determine what class I or class II devices are eligible for review by an accredited person. The 3P Review Program is intended to enable FDA to focus its internal scientific review resources on higher-risk and complex devices, while maintaining a high degree of confidence in the review of low-to-moderate risk and less complex devices by 3P Review Organizations, and to provide manufacturers of eligible devices a voluntary alternative review process that may yield more rapid decisions on 510(k)s than from FDA. Areas Covered in the Session : The 3P Review Process The 9 Current FDA-Accredited 3P “Persons” Accredited Persons’ Qualifications General Categories of Device Subject to 3P Sites for Specific Elgible Device Listings Information Required Important exceptions Pros and Cons, Considerations Who Should Attend: Quality Assurance Departments Regulatory Affairs Departments Research and Development Departments Manufacturing Departments Engineering Departments Operations Departments Production Departments Consultants

$370

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A Bulletproof, Cost-Efficient Supplier Management Program

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company’s purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered “approved.” You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain “approved.” You may never have to pay a visit to your supplier if you have a great supplier control program in place. Areas Covered in the Session : QSR and ISO 13485 requirements for supplier selection and assessment How to qualify new suppliers in a cost efficient manner How to assess current suppliers in a cost efficient manner How to perform supplier-related corrective action Minimum documentation requirements for supplier qualification, assessment, and related corective action Who Should Attend: Purchasing Departments Regulatory Departments Quality Assurance Departments Consultants

$350

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Additive / 3D Printing Manufacturing and Its Regulatory Issues

Additive Manufacturing (AM) or 3D Printing for manufacturing of medical devices is a new and rapidly expanding field, with rapidly expanding regulatory concerns. What is it? What are US FDA stated concerns? This webinar will focus on the key elements of AM, the concerns, and a recent Dec 2017 guidance document on the subject. Medical device companies have begun adopting additive manufacturing, also known as 3D printing, to create devices that were previously impossible to make, personalized to the patient, or both. 3D printing can create many types of medical devices from metals, plastics, hydrogels, and even biological materials. New terms, materials usage / application, unique device construction, all raise new metrics and quality concerns. The FDA recognizes this growing technology and customization, and future possible organ replacement potential as well, and has formed their own Additive Manufacturing of Medical Products (AMMP) area within the FDA with state of the art manufacturing equipment and research methods to try to get ahead of the curve. They have also published an initial start at industry guidance with a new document. Areas Covered in the Session : What is Additive Manufacturing / 3D Printing The Design-to-Device Process Methodologies and Materials; Recycling Printing Characteristics and Parameters Unique Device Build Characteristics Standard vs. Patient-Matched Devices Unique Software Considerations Physical and Mechanical Assessment of the Finished Device Acceptance Activities; Test Coupons Validation / Revalidation Submission Requirements Who Should Attend: Research and Development Departments Quality Departments Regulatory Affairs Departments Manufacturing Departments Production Departments Engineering Departments Operations Departments Purchasing Departments Medical products consultants (primarily devices)

$380

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Analytical Method Transfer According to USP General Chapter-1224

This webinar presents a logical, risk-based approach to method transfer based on existing knowledge of method characteristics and effective transfer documentation. The transfer of analytical methods is an important element in the lifecycle management of active pharmaceutical ingredients and pharmaceutical products.Risks in the method transfer process should be considered and mitigated during the planning phase.However, should the method transfer fail, approaches for dealing with this eventuality are discussed. Areas Covered in the Session : Understanding method transfer Types of method transfer Comparative testing Covalidation Revalidation Transfer waiver Method transfer elements Preapproved protocol Analytical procedure Transfer report A risk-based approach to method transfer documentation to de-risk the method transfer process Dealing with method transfer failures Understand the essential elements of the method transfer process Be able to select an appropriate method transfer approach Understand how to evaluate risk in the method transfer process Have the necessary knowledge to reduce method transfer risk by reviewing method performance, writing suitable method transfer documentation and setting appropriate acceptance criteria Who Should Attend: Analytical Development Laboratory Management Quality Assurance Quality Control Staff Managing Outsourced Testing

$350

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Analytical Method Validation and Transfer

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH, and USP have each recognized the importance of this relative to the drug development process and have each expanded method validation requirements in recent years. However, with only limited guidance, the industry has been left to interpret how to adequately comply with the regulations. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. Why You Should Attend: Join this session to gain the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC. This course will provide a thorough review of regulatory guidelines on method validation and transfer. Each element required to have a complete and thorough method validation will be discussed in detail to ensure course attendees have a clear understanding of each requirement. A review of validation protocol requirements and selection of appropriate acceptance criteria will also occur during the webinar session; as well as, a discussion on how to select suitable statistical calculations for reporting and interpreting the data. Areas Covered in the Session : Regulatory Requirements/Guidance on Analytical Method Validation – Terminology defined: qualification, validation, revalidation and verification – FDA, EMA, ICH requirements and guidance Analytical Method Pre-Validation – Stage 1 – Analytical Target Profile (ATP) – ICH Q8, Q9 and Q10 adherence – Pre-Validation Requirements Analytical Method Validation Characteristics – Stage 2 – Specificity, accuracy, precision, linearity, range – LOD and LOQ Test Method Validation Protocol – Elements of a validation protocol – Pre-planning and planning steps Test Method Validation Report – Elements of the validation report – Elements of the validation protocol and the associated final validation report Who Should Attend: Quality Assurance Departments Quality Control Departments Regulatory Affairs Departments Validation Departments Analytical Development Teams

$350

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Analytical Method Validation under Good Laboratory Practices (GLPs)

Good Laboratory Practices training (GLP) is essential to any laboratory that supports products for sale or use in the United States. GLP much like GMP ensures a comprehensive system that guarantees validity of results and overall quality. Pharmaceuticals, chemicals, petrochemicals, and environmental analyses companies mandated to be following GLP training. A central aspect of GLP is validation of an analytical method. Completely new compounds are being developed each day in pharmaceuticals, structures that have never studied before by chemists. Their properties – such as solubility and acid-base nature, are unknown. Synthetic reactions may create similar types of molecules, including structural and optical isomers. The methodologies that warrant US FDA compliance with GLP regulations require being able to separate and identify all major, minor, and trace components. No longer is it just determining a purity of the main component, environmental analysis is a pre-requisite. As per GLP requirements, each minor contaminant or degradation product is also important. Why You Should Attend: This webinar will discuss analytical method validation and the best practices to follow, including components of a validation. We will also cover how to include critical reagents comparison, selectivity experiments, assessment of stability. The importance of communication between the development and the validation labs and accuracy of transfer documents (SOPs training) will also be addressed. Participants will be able to answer and understand – Is validation a regulated activity? Recognize when to pull the trigger for validation and the importance of suitability testing. Areas Covered in the Session : Method Validation The criteria for a method Statistical requirements Documentation requirements Maintaining Compliance Common issues Who Should Attend: Analysts Lab Supervisors and Managers QA Managers and Personnel Consultants Validation Specialists Chemists

$350

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Applying Computer System Validation to Mobile Applications

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Artificial Intelligence (AI) Algorithms as Medical Devices – Regulatory Requirements

This webinar will discuss the impact of incorporating Artificial Intelligence based algorithm on the premarket regulatory requirements from medical devices and healthcare products. The regulatory requirements associated with AI based software as medical device products will be mapped and the regulatory classification of AI based products in the US and the EU will be outlined. This webinar aims to inform entrepreneurs, product architects, designers, developers, regulatory and quality professionals so that they can understand the regulatory expectations from AI based algorithm software as a medical device. Areas Covered in the Session : AI in healthcare – brief overview The impact of AI based algorithms on medical device classification Impact on pre-market regulatory requirements in the US and the EU Clinical validation of AI based medical devices Who Should Attend: CEO’s, entrepreneurs of AI based algorithm software as medical devices that wish to understand the regulatory landscape. Product managers and designers that wish to understand how the regulatory requirements shape their products requirements and development standards. Quality and regulatory professionals that are responsible for regulatory compliance of AI based products. Medical professionals and Clinical specialists that are engaged in the development and commercialization of AI based healthcare products.

$380

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Aseptic Process Overview and Validation

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors. Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety. This course will also review the guidance provided in USP <1116> to ensure compliance with regulatory expectations are met. Areas Covered in the Session : At the completion of this course, attendees will be able to: Explain the difference between Aseptic and Bulk processing Understand facility and personnel requirements necessary to maintain microbial control Explain basic principles of aseptic processing, including: Cleanliness classifications Process differences between aseptically produced and terminally sterilized product Relation of manufacturing and handling procedures to sources of product contamination Elements of a robust environmental program and why EM is important The role of isolator technology Process Validation Requirements: How to Perform a Successful Media Fill Process Validation Requirements: Sterile Filtration Validation Who Should Attend: Quality Assurance Departments Quality Control Departments Facilities Departments Engineering Departments Operations Departments Manufacturing Teams Quality Engineers

$350

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Aseptic Process Simulations – A Comprehensive Guide for Proper Execution

Aseptic processing, the technique used to ensure sterile drugs are packaged in sterile containers, is one of the most important steps in biopharmaceutical manufacturing, because of the risk that contamination poses to patient safety. An Aseptic Process Simulation is performed by these biopharmaceutical firms to ensure the process can be performed with minimal contamination. This is accomplished by using growth medium instead of the actual product in the processing steps. Regulators look for these Aseptic Processing Simulations or Media Fills, as they are sometimes called, to demonstrate control of the process and also the operators executing the tasks. These simulations must be done periodically and with the knowledge of the regulations that govern them. Why You Should Attend: This webinar will help those using APS/media fills to determine their risks of contamination in the process and how they can prevent it. A complete review of what elements need to be included in the APS design will be discussed, which includes, frequency of performance, number of operators, what types of growth media to use, how slow or fast the filling line needs to operate and how to read the units after they have been incubated. Areas Covered in the Session : We will review the current regulatory requirements for Aseptic Process Simulations (APS) The elements of a successful APS (interventions, worst case conditions, etc.) How to use an APS to qualify operators What types of risk exist that could cause contamination in your process How to properly examine the units once incubated Who Should Attend: Lab managers Regulatory personnel Quality control analysts QA professionals Manufacturing operators Sterility assurance professionals

$350

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Best Practices in Preparation for an FDA Computer System Audit

The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and have evolved over the last thirty years to align with changes in technology and best practices developed by industry, including the inclusion of risk assessment as a critical component of validation. Validation of computer systems in the regulatory environment must be a continuous rather than a discrete process. When auditing, regulatory agencies will expect you to have adequately planned and executed your computer system validation effort, and continue to maintain your system in a validated state. There are specific best practices to be followed that will ensure you are fully prepared to defend your program and prove that you have thoroughly validated your computer systems that are subject to regulatory scrutiny. Being prepared will ensure a much easier interaction with the regulatory agency and will minimize the time and cost of the audit. A company’s readiness may also minimize the risk of findings and citations by showing the auditors that you have done due diligence and are able to respond adequately to all questions and requests for information in a timely manner. Areas Covered in the Session : Describe the key components and importance of regulatory audits of validated computer systems Discuss best practices for preparing for a computer system validation audit by a regulatory agency Provide examples of the documentation you can prepare to minimize risk and ensure your audit is successful Discuss best practices for participating in a computer system validation audit by a regulatory agency Provide examples of what you can do during the audit to minimize risk, time and overall cost Discuss best practices for developing a positive relationship with regulatory agency auditors and building a reputation for preparedness, thoroughness and integrity Interactive Q&A Session Who Will Benefit: This webinar is intended for those working in FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include: Compliance and Audit Managers Information Technology Analysts Information Technology Developers and Testers QC/QA Managers and Analysts Clinical Data Managers and Scientists Analytical Chemists Laboratory Managers Automation Analysts Computer System Validation Specialists GMP Training Specialists Business Stakeholders/Subject Matter Experts Business System/Application Testers

$350

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Big Data – Tools and Trends for Improving your Quality System

Data, data everywhere. In today’s world, we have access to tremendous amounts of data. Yet, it is difficult to translate this data into useful information. Translating data into meaningful information is a capability that can be a competitive strength in improving quality and compliance. Data Management and Quality metrics can help you with forecasting, resource allocation, risk management, decision making, and continuous improvement. Bad data means bad decisions! Management Review is one of the fundamental requirements of a suitable quality system. And it relies on timely, accurate and complete information to make risk-based decisions. Areas Covered in the Session : What metrics are needed for quality and compliance success Sources of data Analytics capabilities Descriptive and Predictive Data Structure and process for managing data Data Governance Data Preparation Using data for forecasting, continuous improvement, and management review Who Should Attend: Quality Departments Compliance Departments Internal Auditors Quality Systems Specialists IT Departments CAPA Specialists Regulatory Affairs Departments Management Representatives Process Owners wishing to monitor and improve their processes General Managers wanting to reduce Quality and Compliance Risk

$320

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Onboarding In A GMP Environment – Best Practices

Onboarding in a Pharmaceutical Good Manufacturing Practices (GMP) environment is a difficult task. Compliance considerations, your quality culture, and work culture are all important points of focus. Additionally, where does employee “onboarding” end and real “job training” start? Your onboarding effort is critical in so many other ways too, as it represents your only opportunity at a first impression, and allows you to shape early motivation for your new employees. Although many hiring managers and other supervisory personnel struggle with onboarding, there are simple steps you can take to ensure a successful and compliant program. This interactive, 90-minute course will address the issues that accompany onboarding new or transferred employees, plus enable you to customize your efforts based on job function.

$350

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Guideline to Aseptic Technique and Clean Room Behavior

More than 175,000,000 individuals have been affected by HIPAA data breaches. During the last year, 78% of HIPAA breaches are caused by human error. That means almost all of those breaches may have been prevented. Does your organization have the required safeguards in place? Have you trained your workforce? Do you have HIPAA policies and procedures in place?

$350

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FDA, EU and MDSAP Inspections – Getting Prepared

Inspections are critical to the success of business on several levels. Therefore, being appropriately prepared and management of the inspection process is a critical activity. The consequences if a company does not pass an inspection are time consuming, delayed product approvals, and could lead to civil or even criminal litigation by the FDA and EU inspection agencies.

$370

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FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

The United States Food and Drug Administration (FDA) can approve small molecule drugs and some biologics under the regulatory pathway 505(b)2. The 505(b)2 regulatory pathway allows an applicant to submit a new drug application for approval of different formulations, dosage forms, indications or combination products of drugs and biologics that have been already approved by the FDA. Basically, 505(b)2 permits an applicant to rely on the safety and effectiveness data of a previously-approved product. More specifically, an application under the 505(b)2 is one for which one or more of the investigations relied upon by the applicant for approval were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted according to the applicable law.

$350

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Establishing and Regaining Control of Cleanroom

This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and bringing up the cleanroom after a worst case event will be discussed. Cases studies on bringing up the site after a worst case event will be detailed. Excursion investigations and troubleshooting parameters and suggestions will also be discussed.

$350

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Advertising and Promotional Material Compliance and Review Process

The webinar will address requirements for compliance, “gray areas,” risk assessment, opportunities for input from regulatory agencies, and review process and procedures. This webinar will address issues of compliance in the creation of advertising and promotional materials and the appropriate internal assurances that compliance of materials is appropriately assessed, evaluated, and documented. The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance, “gray areas,” risk assessment, opportunities for input from regulatory agencies, and review process and procedures.

$350

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Writing Validation Master Plans – Best Practices for Writing a Compliant Document

This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans will be discussed as well as effective guidelines for authoring a VMP and a team writing approach to authoring a Validation Master Plans will be discussed.

$350

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HPLC Instrument Qualification and Method Validation

HPLC instrument qualification and analytical method validation are two related topics that are essential to compliance in regulated laboratories. This webinar will provide details of current regulatory guidance and examples of best practice in each of these areas. The information provided will enable you to assess the level of instrument qualification compliance in your laboratory and identify any gaps, as well as helping you to successfully plan and execute a method validation exercise.

$360

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EO Sterilization Validation / Revalidation per ISO 11135

This webinar will outline the required elements of a successful ethylene oxide (EO) sterilization validation process for medical devices as required by ISO 11135:2014. Hardware / chamber and software considerations and required documentation. Temperature and humidity mapping, BIs / PCDs and their placement. Basic system. A brief discussion of the lethal rate BI / bioburden approach, and a more detailed discussion of the more commonly used Overkill approach descriptions, IQ, OQ, PQ – MPQ / PPQ.

$370

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GLP Regulations – Introduction and Strategies for Implementation

Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don’t know exactly what GLP really means, or what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment. Attend the seminar to get a good understanding on GLP regulations and get best practice guides and strategies for easy implementation.

$359

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Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls

After the Final Rule of the Quality System Regulation became effective, a moratorium on enforcement was placed for one year, until the ISO regulations went into effect for design control for medical devices. Since the design control regulations became effective, many warning letters has been issued for failures to fully implement the controlling regulations. This webinar will focus on the records that make up the key regulatory documents, the DHF, DMR and DHR. We will discuss the effect of Change controls on the aforementioned regulatory documents, as any changes in design and production must be proposed, accepted, changes documented and verified to have no unintended consequences on the device.

$380

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Packaging and Labeling in Pharmaceutical Product Development – Best Practices

Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities are also crucial for compliance with regulatory agency requirements. Still, their importance is often underestimated, especially in the planning phases, which leads to unnecessary increases in cycle time, costly errors, delays in product availability, or product recalls due to noncompliance. Understanding the packaging and labeling process in the larger product development process will provide you an advantage in achieving success.

$350

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Laboratory Safety – All You Need to Know

In this training program, attendees will gain an understanding of general laboratory safety and common lab operation procedures. The course will also instruct on what PPE to provide such as safety goggles, aprons, gloves, eyewash stations, fire extinguishers, first aid kits, etc. This webinar is designed to teach general practices that should be followed in the laboratory such as providing safety contracts/ SOPs, identifying medical and allergy problems, posting and modeling all safety procedures, knowing district and state policies concerning reporting injuries, being familiar with fire regulations, posting and discussing emergency escapes, and providing personal protective equipment for all occupants and personnel.

$350

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4-Hour Virtual Seminar on Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.. This seminar will analyze each of these necessary elements of the batch record review process.

$598

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How to Ensure Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists

This webinar will give information on auditing foreign vendors for FDA compliance. It will discuss initiating audits, planning and preparing vendor audits, as well as, monitoring foreign vendor compliance. This webinar will provide FDA guidance on foreign vendor expectations, what to do and what not to upon selecting a foreign vendor. It will also provide audit formats and checklists for ensuring a foreign vendor is qualified.

$350

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Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

Bacterial Endotoxin Test (BET) is a vital safety requirement in the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and the medical device quality system regulations. A solid grasp of the concept of this critical release assay, its application and importance to the manufacture of cGMP product is paramount. This helps avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone. This webinar has been designed to provide the experienced technician with an extensive understanding of how an Limulus amebocyte lysate (LAL) testing program can be applied to quality control so that regulatory requirements enforced by the EU and the FDA are met.

$350

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Successful Change Control Management

This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.

$350

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US vs EU – Medical Devices Compliance and Regulatory Affairs

This webinar will provide an understanding of the structure of both US and EU regulatory bodies. The regulatory content common to all regulations will be addressed to create a foundation for understanding the basics of medical device compliance regulations. We will then discuss the meaning of regulatory compliance from both an internal – company, and external – regulatory body standpoint.

$350

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Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This webinar will help you understand in detail the new requirements for trial master files. You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file.

$350

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HPLC Instrument Qualification and Method Validation

$360

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Statistical Power – Understanding, Calculating, and How to Effectively Use it

Statistical power is an indicator of the ability of a test of significance to “detect” a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of “non-significant” is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun. This webinar provides thorough training in how to interpret and use the power-analysis outputted by text-book calculations or software programs modules (e.g., StatgraphicsCenturionXV).

$370

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U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval Process

What are the various routes to US FDA device clearance / approval? The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the extremely costly, time consuming and rigorous PMA approval process. What is the De Novo provision? The US classification system. For clinical trials, an IDE (Investigational Device Exemption) submission is required. The FDA holds companies responsible for filing new 510(k)s, or IDEs / PMAs when new products are to be marketed in the U.S., or when existing products and/or their Indications for Use are changed.

$370