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.
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Webinar Training Pass
Recorded on: Dec. 16, 2015
Description: Food industry attorney Kathleen Hardee explains new FDA rules on preventive controls for human and animal foods. She covers:
- The FDA's "Seven Pillars" and the schedule for their implementation;
- What your food safety plan must include; and
- Who is a preventative controls qualified individual.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kathleen A. Hardee, Co-Chair, Food & Ag Group, Polsinelli
Recorded on: Dec. 15, 2015
Description: Noted European law specialist Elisabethann Wright discusses developments in the EU's pharmacovigilance system. She covers:
- The difference between getting marketing authorization and renewing it;
- The new rules on post-authorization efficacy studies;
- The powers of the Pharmacovigilance Risk Assessment Committee and their relationship with the Committee on Human Medicinal Products; and
- The significance of the "Black Triangle."
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Elisabethann Wright, BL, Partner in Brussels, Belgium office, Hogan Lovells International
Recorded on: Dec. 15, 2015
Description: Supply chain strategist Evren Ozkaya discusses serialization requirements are in various stages of development in several countries and explains why, how and when to prepare to follow new track-and-trace rules globally. He covers:
- Deadlines for serialization and how your timeline must reflect them;
- How your supply chain needs to transform its technology for compliance; and
- The biggest myths and misconceptions about track-and-trace.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Evren Ozkaya, Founder and CEO, Supply Chain Wizard, LLC
Recorded on: Dec. 11, 2015
Description: Regulatory affairs expert Kristen Henderson helps in-house counsel and regulatory experts navigate the dynamic international informed consent landscape by providing practical advice and highlighting technical and ethical considerations. She discusses:
- Regulatory environment factors;
- Cultural differences;
- E-Consent and other data protection/confidentiality considerations; and
- Data-sharing initiatives.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kristen M. Henderson, Legal Director, Quintiles
Recorded on: Dec. 10, 2015
Description: Human factors specialists Debbie McConnell, Krista Alley Smith and Kayla Carter share a "whole team" approach to performing a usability inspection in order to collect robust design inputs. Using a 5-point scoring system this approach illustrates the areas of the design that present the most significant usability problems along with design improvements to address these issues.
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Speakers: Debbie McConnell, Human Factors Lead, Krista Alley Smith, Industrial Designer, Kayla Carter, Systems Engineer, Battelle
Recorded on: Dec. 9, 2015
Description: Biopharmaceutical industry expert Vadim Klyushnichenko outlines the FDA's regulations for equipment and process change, presents a change control flow sheet, and discuss strategies for process development. He talks about:
- The definitions and explanations of a change control system in the biopharmaceutical industry;
- What the regulatory requirements for change control are; and
- What the current process development strategy in the biopharmaceutical industry is and how change control is applied to different phases of drug development and manufacturing.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Vadim Klyushnichenko, President and Founder, Key Pharma Consulting, LLC
Recorded on: Nov. 30, 2015
Description: Regulatory specialist Darshan Kulkarni discusses the evolution of off-label drug promotion policy and court decisions over the past decade. He covers:
- Responding to unsolicited requests for information;
- Documenting off-label discussions; and
- Industry concerns about FDA requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm
Recorded on: Nov. 24, 2015
Description: Recall specialist Chris Harvey explains how to create recall management systems that will ease the process no matter where in the world the recall is conducted. He discusses:
- Current recall metrics and trends;
- Conducting mock global recalls;
- How social media has been utilized during a product recall; and
- Frequent pitfalls and ways to overcome them.
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Transcript: Download the transcript
Speaker: Chris Harvey, Recall Strategist, Stericycle/ExpertSOLUTIONS
Recorded on: Nov. 23, 2015
Description: Dr. Kelly Posner, chief architect of the Columbia-Suicide Severity Rating Scale (C-SSRS) discusses her research, the FDA's guidance on measuring suicidality in clinical trials and how to use the C-SSRS in multiple research settings. Topics include:
- How to use the Columbia-Suicide Severity Rating Scale (C-SSRS) to determine suicidal ideation/behavior categories;
- How a self-rated approach is part of an optimal response to guidance requirements;
- How to reduce site and sponsor burden while providing predictive capability; and
- Operational factors to be considered when capturing the important information.
Presentation: Download the presentation
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Speaker: Dr. Kelly Posner, Founder, Center for Suicide Risk Assessment at Columbia University/New York State Psychiatric Institute
Recorded on: Nov. 18, 2015
Description: GMP consultant Bob Seltzer explains what issues an effective microbiology lab audit should address. Topics include:
- Sampling, sample control and chain-of-custody;
- Employee training;
- Qualifying contractors and reviewing/monitoring their performance and results; and
- Document control and record keeping.
Presentation: Download the presentation
Speaker: Bob Seltzer, President and Principal Consultant, Worldwide GMP Compliance Professional