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. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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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.
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Webinar Training Pass
Recorded on: June 25, 2019
Description: Quality Management expert James “Gunny” Shore shares best practices on evaluating your current QMS, identifying the areas that need to be simplified and making your QMS easier to follow. He discusses:
- How to use the proper tools and methodology to evaluate your QMS;
- How to assemble a gap assessment and improvement plan;
- How to develop a comprehensive roadmap to implement an efficienty QMS through lean manufacturing processes; and
- How to change employees’ behavior to increase productivity.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James “Gunny” Shore, Chief Quality Officer, Quality Lean Solutions
Recorded on: June 24, 2019
Description: Technical expert, author and teacher Jim Polarine shares best practices to stay compliant and get up-to-speed on the latest in risk-based cleaning regulations. He discusses:
- Cleaning and disinfection based on Annex 1 (Draft 2019) and sections of PDA Technical Report No. 70;
- Disinfection rotation;
- Rinsing and residues; and
- Frequencies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim Polarine, Senior Technical Service Manager, STERIS
Recorded on: June 13, 2019
Description: Computer system validation expert David Harrison shares best practices and available options for validating spreadsheets. He discusses:
- FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820;
- How to determine spreadsheet validation gaps the FDA targets;
- How to choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes; and
- How to plan, manage and resource an effective project.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David Harrison, Principal Consultant, CSV Compliance Ltd.
Recorded on: June 11, 2019
Description: Clinical trial solutions expert Kelly Smith shares best practices for how pharma and biotech companies can best take advantage of key performance indicators. She discusses:
- How to improve business development chances by illustrating turnaround times and other metrics when communicating and selling services to potential clients;
- How to develop better feasibility by quickly and easily finding turnaround times, win rates, loss/not selected rates and potential revenue per patient;
- How to accelerate start-up activity by using KPIs to set goals and measure progress/performance against those goals; and
- Choose improved protocols to set attainable enrollment goals and track financials.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kelly Smith, Senior Solutions Consultant, Bio-Optronics
Recorded on: June 11, 2019
Description: Business strategist and training experts John Constantine and Kent Malmros Systems share best practices for managing multiple training platforms and complex training requirements. They discuss:
- Delivering compliance-based applications with greater efficiency;
- Supporting blended roles and enabling a more succinct learner experience;
- Ensuring compliant training records and reports are in one place; and
- Providing traceability of the development and delivery lifecycle for all training materials.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: John Constantine, Senior Vice President of Talent Solutions, Orchestrall, and Kent Malmros, Senior Director of Vault Training at Veeva Systems
Recorded on: June 6, 2019
Description: Quality systems expert Dan O’Leary shares pain points involved in design changes as they are related to FDA regulations. He discusses:
- The relationship among design output, design transfer and production control;
- Elements of the new UDI rule;
- The requirement to evaluate change significance for 510k submissions; and
- Implications for FDA inspections.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: May 30, 2019
Description: Operational Excellence expert Dan O’Leary shares compliance and process validation procedures. He discusses:
- QSR requirements for process validation;
- ISO 13485:2016 requirements for process validation;
- Linking sampling verification to the process model; and
- Process validation’s role in risk management.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: May 30, 2019
Description: Food and drug regulatory expert Pamela Forrest shares best practices for compliance with Part 806. She discusses:
- The nuances of Part 806 and when to report a recall;
- How recalls differ from enhancements;
- The handling of different classes of device recalls; and
- Enforcement actions, liability and product seizures.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Pamela Forrest, Partner, Food, Drug and Device Practice, Covington & Burling
Recorded on: May 29, 2019
Description: FDA legal expert Roseann B. Termini shares insights into four top issues currently being debated as new approaches to life science regulation. She discusses:
- The opioid initiative and task force;
- Guidance on the Right-to-Try law;
- Dietary supplement regulation; and
- Biosimilar development and the BPCI Act guidance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Roseann B. Termini, Food and Drug Lawyer
Recorded on: May 22, 2019
Description: Regulatory experts Kalah Auchincloss, Kevin Madagan and Wayne L. Pines discuss how changes and reforms made under former FDA Commissioner Scott Gottlieb will fare under new management. They cover:
- Policy decisions on generic drug approval;
- Reorganization of the Office of New Drugs;
- Further changes in the FDA’s policies on advertising and promotion regulation; and
- Changes in FDA standards for clinical trials.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kalah Auchincloss, Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health; Kevin Madagan, Partner, Reed Smith, LLP; and Wayne L. Pines, President, Health Care, APCO Worldwide