Duration: 90 Minutes
Duration: 60 Minutes
Duration: 4 Hour
Duration: 75 Minutes
Duration: 3 Hour
Duration: 3 Hours
Duration: 4 Hours
Duration: 90 Minutes | Course Director: PAM DELLEA-GILTNER
Faculty: HitendraKumar Shah
Duration: 75 Minutes | Course Director: DANIELLE DELUCY
This exclusive Pack of webinars contain 7 courses: 1. Laboratory Controls – Anticipate the Systems Based FDA Inspection 2. Analytical Method Validation and Transfer 3. Auditing Laboratory Data Systems 4. Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance 5. Handling OOS Test Results and Completing Robust Investigations 6. Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries 7. Establishing a Product Stability Testing Program Total Duration: 12 Hours
Presenter: Danielle DeLucy
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
The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing. This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing. Areas Covered in the Session : Provide background information on what microbiological aspects to audit. What international regulations should be referenced. ISO classification of rooms and how it should be applied Validation and qualification of bioburden and manufacturing suites. Key sources of microorganisms and why this is important What the source means in terms of root cause Product bioburden and why bioburden is important. Who Should Attend: Quality Departments Manufacturing Departments Engineering Departments Regulatory Departments Microbiologists Contract Manufacturing Organizations
Just as everyone was beginning to get conversant with GDUFA’s confusing three-tier system, the FDA, on July 4, 2018, finalized the GDUFA II guidance! The final guidance simplifies the designation of amendments into two broad categories—Standard or Priority—while classifying them as either Major or Minor. But that has not yet made things easier for many ANDA (Abbreviated New Drug Applications) applicants. There’s still a lot of ambiguity around amendments to ANDAs and PASs (Prior Approval Supplements) – and not having clarity could cost your organization time, money, and other resources. This webinar will walk you through the amendment format and submission process. You will learn how the GDUFA II review goals apply to amendments to ANDAs and PASs; how the amendment submissions may affect the review goal dates; how ANDA or PAS deficiencies may cause the FDA to request a major amendment, as well as how to request the FDA to reconsider classifying a major amendment. This webinar will bring absolute clarity on the FDA review goals for amendments under GDUFA II. After attending this webinar, you will achieve a greater working understanding of GDUFA II and its most recent final guidance. Moreover, you’ll also get to know how the FDA will process amendments submitted before GDUFA II. Plus, you’ll be confident in your ability to bring generic drugs to market quickly and in compliance with the GDUFA II requirements. Areas Covered in the Session : Purpose and scope of GDUFA II The FDA’s process for classifying major, minor, and unsolicited amendments to ANDAs or PASs The amendment format and submission process The FDA review goals for amendments under GDUFA II How the FDA will process amendments submitted before GDUFA II How ANDA or PAS deficiencies cause the FDA to request a major amendment or classify deficiency responses as a major amendment How to request the FDA to reconsider classifying a major amendment How high quality standards are maintained through inspections and risk-based approaches The process of and reasons for requiring the identification of the facilities involved in the manufacture of generic drugs and the associated Active Pharmaceutical Ingredients (APIs) How amendment submissions may affect review goal dates Who Should Attend: Compliance and regulatory affairs professionals Project managers QA & QC managers R&D staff Generic drug manufacturers API manufacturers ANDA sponsors Consultants Directors, associate directors and associates Generic drug industry professionals
Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products, particularly in the manufacture of sterile medicinal products. Major changes have recently been made to the EU GMP guideline covering manufacture of sterile medicinal products (Annex 1). This webinar is designed for staff who are new to working in sterile manufacturing or who wish to learn about the recent Annex 1 revisions. It will discuss what controls and documentation must be in place to ensure product quality and patient safety for both aseptically prepared and terminally sterilized products. Areas Covered in the Session : GMP regulation of sterile products Why are sterile products different? Background to the Annex 1 guideline Importance of product, equipment and people flow Room classifications and particulate monitoring Sterilization methods for materials and equipment Contamination by operators: the importance of gowning Water systems Media fills Who Should Attend: Staff involved with manufacture of sterile medicinal products to be marketed in EU Quality Assurance Departments Manufacturing Departments Regulatory Affairs Departments Research and Development Departments GMP/GDP Compliance Departments Contract Manufacturing Organizations
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
Presenter : Dr. Loren Gelber | Duration : 60 Minutes
Most regulatory agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, in order to demonstrate compliance, there must be written procedures for a batch record review process. The production and manufacture of pharmaceuticals, biologics, medical devices, etc., involve critical processing parameters. In order to properly document these processing parameters, a strong batch record review system is essential. This webinar will analyze each of these necessary elements of the batch record review process. Upon completion of this session, you will learn the fundamentals for reviewing batch records in a pharmaceutical environment. You will hear about the proper training that must be demonstrated to be considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records. Areas Covered in the Session : Recognize regulatory requirements for batch records and batch record review Understand the essential and necessary qualifications and training of batch record reviewers Establish a working relationship between production and quality reviewers What to do when a batch fails to meet specifications (discrepancies and deviations) Parameters of efficient review of batch records good documentation practices, compliance to essential quality attributes and critical processing parameters Skills and responsibilities of an effective batch record reviewer Tools to achieve an effective batch record review Ensuring Production and Quality reviewers coincide with their reviews Creating an extensive training plan for batch record reviewers and when they can be considered qualified to review a record
Presenter: Michael Esposito Duration: 4 Hours Recording Access Valid for: 6 Months
Presenter : Joy McElroy Duration: 3 Hours Group Recording - 6 months validity
Presenter : Danielle DeLucy Duration : 75 Minutes