Simplifying Global Compliance
The Webinar Training Pass
Now get all the training you need – all in one place, and all for one low price!
The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!
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.
Select webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.
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Webinar Training Pass
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
Recorded on: May 15, 2019
Description: Technology expert Filip Matakovic shares best practices for making the transition to an electronic regulatory (eReg) binder system. He discusses:
- System compliance and audit readiness;
- Costs and current methodology of paper binder storage;
- Advantages of managing documents electronically; and
- eSignatures and Part 11 compliance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Filip Matakovic, VP and General Manager, Site Services Group, MedPoint Digital
Recorded on: May 15, 2019
Description: Legal expert Rachael Hunt shares best inspection practices and examines the new draft guidance on requesting FDA advice on remedying Form 483 findings. She discusses:
- Interacting with FDA investigators;
- The role of the CDRH ombudsman;
- How to respond to fallout from an inadequate response; and
- Soliciting nonbinding 483 feedback.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Rachael E. Hunt, Hyman, Phelps & McNamara, P.C.
Recorded on: May 9, 2019
Description: Compliance management experts Ujjal Chakravartty and Morgan Palmer share best practices for adapting to the Medical Device Single Audit Program (MDSAP). They discuss:
- Key elements of ISO 13485 and MDSAP;
- The payoff for making the MDSAP transition;
- Issues that may crop up along the way; and
- How medical device leaders are preparing for migration.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Ujjal Chakravartty, Director of Global Quality Systems, Avanos Medical Inc.; Morgan Palmer, Chief Technology Officer, ETQ
Recorded on: April 25, 2019
Description: FDA assistant commissioner Heidi C. Marchand reviews the final guidance on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway. She discusses:
- Labeling indications and usage section for products approved under the Accelerated Approval pathway;
- Product approvals based on a surrogate or intermediate clinical endpoint and inclusion in the product label;
- Revising the indications and usage section on verification of clinical benefit from postmarketing studies;
- Referencing postmarket study requirements for continued approval of the indication; and
- Withdrawals of an accelerated approved indication and removals of information about the withdrawn indication from the labeling.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Heidi C. Marchand, Assistant Commissioner, Office of Health and Constituent Affairs, Office of External Affairs, Office of the FDA Commissioner
