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

This training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation. The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do. Areas Covered in the Session : Understand what a supplier and vendor audit is Understand the background and basics of supplier and vendor auditing Understand proper auditor conduct Communication Dress Punctuality Difficult situations Learn the necessary skills for conducting audits Understand how to prepare and plan for a supplier and vendor audit Understand and know how to properly perform an audit Opening meeting Touring the facility Questions Observations Close out meeting Learn proper questioning techniques Understand proper audit observation classification Learn to write an audit report Understand conducting a follow up audit Learn how to become lead auditor certified ASQ Certification ISO Certification Who Should Attend: Senior Quality Managers Quality Professionals Regulatory Professionals Compliance Professionals Production Supervisors Validation Engineers Manufacturing Engineers Production Engineers Design Engineers Process Owners Quality Engineers Quality Auditors Document Control Specialists

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

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

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

This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain. The focus will be on how this can enhance cMGP compliance while it strengthens a company’s critical supply chain. This webinar will explore the growing use of blockchain in supply chain control. Basically, blockchain is a time-stamped series of records of data that is managed by a distributed, networked cluster of computers under multiple ownership. Under blockchain, individual blocks of data is secured and bound/ “chained” to each other under cryptographic principles. First used for Bitcoin, it has since expanded into mainstream business use, with it’s most immediate use to date in supply chain management. Major names in the industry, such as IBM, offer the technology. With no central authority in the blockchain network, it basically presents a shared ledger. Data is open for anyone to see – transparent. It makes everyone involved is accountable for their actions, which are limited, recorded, and available for review and/or further action. Why You Should Attend: Blockchain implementation require planning, verification, testing, validation, traceability, configuration management, conformance to software V&V including 21 CFR Part 11 – electronic records and electronic signatures, and other aspects of good engineering. These assure they meet existing CGMP regulations. The cGMPs and FDA requires the integration of life cycle and risk management activities into the planning, implementation, and maintenance of a blockchain facilitated supply chain. Learning Objectives: What is “blockchain”? Basic building blocks of blockchain Blockchain and the supply chain Blockchain and pedigrees Blockchain and counterfeit product Current state of blockchain in FDA regulations / the cGMPS Key areas of the cGMPs – Device and Drugs – impacted by blockchain Implementation in the supply chain US FDA compliance inspection objectives in supply chain blockchain implementation Further potential Understanding the challenges Areas Covered in the Session : What do the cGMPs require? Intent of 21 CFR Part 210, 211, and 820 as they affect blockchain in the supply chain Key FDA Regulatory concerns Responsibilities Key Definitions Working Definitions Risk Management / Assessment Quality Agreements Challenges Who Should Attend: Quality Assurance Departments Quality Control Departments Research and Development Departments Regulatory Affairs Departments Compliance Departments Manufacturing Departments Engineering Departments Operations Departments Production Departments Purchasing Departments Inventory Control / Management Process Development Engineers Software Engineers

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

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

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

This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, India, Japan, and Korea. The medical devices are currently one of the fastest growing industries. The current knowledge and accurate understanding and adequate interpretation of global medical device laws, regulations and regulatory requirements have become increasingly important in our competitive global market. Global regulations of medical devices are rapidly evolving, which necessitates the integration of regulatory schemes available and applicable in various regions of the world to best develop a practical, actionable and sustainable regulatory plan and strategy. For many reasons, Asian medical device markets are highly attractive. Thus, it is imperative we get familiar with currently applicable and relevant laws and regulations governing medical devices, further streamlining the regulatory process. In this webinar, the speaker will discuss the updated differences in regulatory frameworks (regulatory requirements and compliance) in Asia, intending to help you understand and accurately interpret applicable laws and regulations governing medical devices in China, India, Japan and Korea. This webinar will help you expedite the registration process for your devices in these Asian countries. Speaker will present laws and regulations governing medical devices in China, India, Japan and Korea. It is designed to help medical device industry implement practical, actionable and sustainable strategy for device registration in these countries and further to streamline their business planning and registration process in Asian countries. Areas Covered in the Session : Updated medical device laws and regulations in China, India, Japan and Korea. Definitions, Device classification and rules Regulatory framework for medical devices in China, India, Japan and Korea. Regulatory requirements for medical devices including in vitro diagnostic devices in China, India, Japan and Korea. How to identify and address the regulatory requirements How to establish and maintain systematic methods to meet the regulatory requirements. How to streamline the regulatory process. PASS-IT Recommendations: Best Practices Interactive Q&A session Who Should Attend: Regulatory Affairs Managers, Directors and VPs Clinical Affairs Managers, Directors and VPs Quality Managers, Directors and VPs Quality Managers, Directors and VPs Compliance Managers and Directors Sales and Marketing Managers, Directors, and VPs Complaint Handling and Risk Management Managers and Directors Site Managers, Directors, and Consultants Senior and Executive Management Compliance Officers and Legal Counsel Business Development Managers, Directors, and VPs

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

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

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

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

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

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)

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

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