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Webinar Training Pass
Recorded on: July 27, 2017
Description: Regulatory experts Lisa Dwyer and Heather Bañuelos discuss the FDA’s three guidances covering medical product communications. Topics include:
- What “consistent communications” means v. on-label and off-label communications;
- How the FDA interprets the “three factor test” for consistent communications and how to apply it in practice;
- How to evaluate consistent communications as “scientifically appropriate and statistically sound;” and
- The real-life scope of the new safe harbor for pre-approval communications with payors.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Lisa M. Dwyer, Partner, and Heather Bañuelos, Counsel, King & Spalding
Disinfectant Testing and Validation
91 minutes
Recorded on: July 26, 2017
Description: Microbial control expert Jim Polarine lays out the problems facing manufacturers plus state-of-the-art solutions. He discusses:
- Proven ways to limit cleanroom contamination from incoming items;
- Proper cleanroom design and condition;
- Best products to control bacterial and mold spores; and
- Current sporicide and disinfectant regulations in the U.S. and the E.U.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim Polarine, Senior Technical Service Manager, STERIS Corporation
ICH Stability Requirements
66 minutes
Recorded on: July 20, 2017
Description: CMC program design specialist Wayland Rushing interprets stability requirements in ICH Q1 and explains how to tailor a compliance routine to fit your specific products. He discusses:
- The requirements for ICH stability studies;
- The requirements for analytical methods; and
- How to interpret data generated by the stability programs.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Wayland Rushing, Director of Scientific Affairs, EAG Labs
Spreadsheet Validation
88 minutes
Recorded on: July 18, 2017
Description: Computer system validation expert David Harrison discusses best practices and available options for validating spreadsheets. He covers:
- Exactly what the FDA looks for and why;
- Spreadsheet validation "gaps" the FDA is targeting;
- How to generate spreadsheet specifications and qualification protocols; and
- How to test spreadsheets and macros.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David Harrison, Principal Consultant, CSV Compliance Limited
FDA’s Big 5 Challenges
83 minutes
Recorded on: July 13, 2017
Description: Life sciences lawyer Roseann Termini discusses the biggest challenges facing the FDA in 2017, including:
- Botox approvals;
- Marijuana regulation;
- The Opioid task force;
- The Intended Use rule; and
- The Right-to-Try movement.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Roseann Termini, Editor, Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements
Recorded on: July 12, 2017
Description: Statistician Steven Walfish outlines the requirements for statistical techniques and sample size and explains how they impact design control processes. He discusses:
- Common sources of errors;
- What types of requirements lend themselves to statistics in verification and validation; and
- Examples of problems in which we apply statistics.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steven Walfish, President, Statistical Outsourcing Services
Develop a Process Validation Roadmap
67 minutes
Recorded on: June 27, 2017
Description: Validation experts Rich Yeaton and Kelly Thomas share their road-tested template for using existing process validation data to satisfy regulators. They discuss:
- How to use the template to zero in on the statistics that matter — and avoid wasting time validating things that don't matter;
- Understanding the nuances of the new FDA final guidance; and
- Implementing a plan that covers all the bases — process design, qualification and continued verification — in exactly the way the FDA expects.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Rich Yeaton, President, Atlantic Technical and Validation Services, LLC; and Kelly Thomas, Vice President of Quality, Atlantic Technical and Validation Services, LLC
Device Design and Risk Management
91 minutes
Recorded on: June 22, 2017
Description: Quality systems expert Dan O’Leary unravels a tangle of FDA rules and international standards that govern design control. He covers:
- Design control from the risk management perspective and vice versa;
- Recognizing when requirements of the one system support/complement requirements of the other; and
- Using product safety standards to improve design control and risk management efficiency.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
FDA User Fees, Drug Competition and Pricing
62 minutes
Recorded on: June 13, 2017
Description: Experts Alex Brill and Nancy Bradish Myers share insights and predictions about the current user fee reauthorization process. They discuss:
- How the FDA affects drug competition at every level — brand-to-brand, brand-to-generic, generic-to-generic, biologic-to-biosimilar;
- Expedited approvals and economic incentives — how the FDA promotes drug competition; and
- Five ways Congress and the FDA can boost competition and the likelihood of each.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Alex Brill, CEO, Matrix Global Advisors, and Nancy Bradish Myers, President, Catalyst Healthcare Consulting Inc.
Medical Devices: The Case for Quality
63 minutes
Recorded on: June 8, 2017
Description: Quality advisors Mark Turner and Michelle Boucher discuss current industry trends, including:
- The Case for Quality and how manufacturers can bridge current gaps;
- How manufacturers should respond to rigid FDA or EU regulations and authorities; and
- Novartis’ approach to the Case for Quality and how it applies current trends in practice.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mark Turner, Service Delivery Manager, Engineering, Novartis/Alcon; Michelle Boucher, Vice President for Research, Tech-Clarity