The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials.
If you are already a Training Pass member, login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video, click the "Download Presentation" link.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
GLP Compliance
69 minutes
Description: GLP compliance expert Anne Maczulak lays out a 10-step strategy for preparing to face FDA inspections, from developing SOPs to conducting mock inspections. Points covered include:
- Developing a pre-audit assessment plan;
- Elements of a safety policy; and
- Roles and responsibilities for staff involved in the inspection.
Presentation: Download presentation
Speaker: Anne Maczulak PhD RQAP-GLP, Principal Consultant, Acorn GLP Consulting
Description: Compliance expert and former FDA investigator Martin Browning presents the EU’s revised rules for managing risks throughout the life of any computerized systems used in a regulated activity, from simple spreadsheets to complex networks. Annex 11, revised in 2011, is the European counterpart to U.S. Part 11 rules for use of electronic systems in manufacturing. Browning explains:
- The principals and scope of Annex 11;
- Differences between Annex 11 and Part 11;
- How the revised rules incorporate standard IT practices; and
- How they differ from the original Annex 11 provisions that had been in place for nearly 20 years.
Presentation: Download presentation
Handout #1 - Comparison of FDA’s Part 11 and the EU’s Annex 11
Handout #2 – Verification vs. Validation: FDA’s Expectations and Why The Difference Matters
Speaker: Martin Browning, President and Co-Founder, EduQuest
Description: Regulatory attorney Alan Minsk examines the impact of 10 key legal cases on the drug industry. Cases presented cover such issues as:
- Reporting adverse events;
- Patent ownership;
- Labeling; and
- Product liability.
Presentation: Download presentation
Speaker: Alan Minsk, Partner and Chair of the Food & Drug Practice Team, Arnall Golden Gregory LLP
Description: Elizabeth Garrard, Chief Safety Officer of the Drug Safety Alliance, explains how statistical signal detection can aid pharmacovigilance and offers tips on how to manage signal detection throughout the lifecycle of a product. Garrard covers:
- What is – and isn’t – a signal;
- Methods for identifying signals;
- Data sources; and
- ypes of questions that can be answered by using data mining methods.
Presentation: Download presentation
Speaker: Elizabeth Garrard PharmD. R.Ph., Chief Safety Officer, Drug Safety Alliance Inc.
Supplier Quality Management
83 minutes
Description: GMP consultant Steven Sharf explains how to address the risks associated with accepting suppliers’ certificates of analysis through regular auditing. Topics include:
- Using risk management tools to determine which suppliers to audit;
- Audit frequencies and schedules;
- Qualifying suppliers for reduced testing; and
- Tailgate sampling.
Presentation: Download presentation
Speaker: Steven Sharf, President, GMP Concepts
Medical Device Quality Audits
92 minutes
Description: John Gagliardi of Midwest Process Innovation LLC interprets the audit requirements contained in the one-paragraph Section 820.22 of the Quality System Regulations, discussing:
- Creating a master audit schedule;
- Establishing the scope of the audit;
- Training personnel for inspections; and
- Auditor qualifications and responsibilities.
Presentation: Download presentation
Speaker: John Gagliardi, President, MidWest Process Innovation LLC
Designing & Executing Observational Studies
72 minutes
Description: Clinical trial data specialist Peggy Schrammel demonstrates how to use patient registries to collect real-world effectiveness and safety data. Topics include:
Considerations for registry design;
- Finding the most suitable data source/approach;
- Using chart review studies to capture data retrospectively; and
- Building effective registry teams.
Presentation: Download presentation
Speaker: Peggy Schrammel, VP-Registries and Post Approval Development, United BioSource
Electronic Health Records and REMS
96 minutes
Description: PDR Network CEO Edward Fotsch discusses the transition to electronic health records as required by 2010 healthcare reform legislation. Fotsch covers:
- How EHRs can cut the time and cost of communicating REMS elements;
- Incentives the law provides for hospitals and providers, and penalties for those that don’t make the switch by 2015;
- Information flow from drugmakers to providers through EHRs; and
- Potential opportunities and liabilities.
Presentation: Download presentation
Speaker: Edward Fotsch M.D., CEO, PDR Network LLC
Description: Regulatory specialists Joan Antokol and John McLane examine the FDA guidance, “Safety Reporting Requirements for INDs and BA/BE Studies,” issued in draft form in 2010 and finalized in December 2012. Topics discussed include:
- Differences in requirements for IRBs, sponsors and investigators;
- Clarification of terminology in FDA regulations prior to 2010; and
- Product liability risks.
Presentation: Download presentation
Handout – Drug Withdrawls In The US
Speakers: Joan Antokol, Managing Partner, Park Legal LLC and Dr. John (Jack) McLane, COO, Clinquest Inc.
Reduce Supply Chain Risks
85 minutes
Description: Former top FDA investigator Martin Browning examines best practices for making outsourcing decisions and navigating FDA regulations. Topics include:
- Selecting suppliers with compatible standards and principles;
- Providing information on suppliers to the FDA;
- Contracts and Service Level Agreements; and
- Continuing improvement of a supplier management system.
Presentation: Download presentation
Speaker: Martin Browning, Founder and President, EduQuest
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