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.
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Webinar Training Pass
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Description: Legal expert Rachael Hunt shares best inspection practices and examines the new draft guidance on requesting FDA advice on remedying Form 483 findings.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
Recorded on: April 24, 2019
Description: Consultant Nancy Reynolds Howard tackles the nuances and best practices for optimizing reimbursement of clinical trial services. She discusses:
- The relationship between documentation of medical necessity and billing compliance;
- The enhancement of billing compliance using medical necessity language and document consistency reviews;
- The connection between the language used in the informed consent form and billing compliance;
- The nuances of specific codes and modifiers for claims under Medicare’s clinical trial policy and investigational medical device regulations; and
- The importance of complying with Medicare diagnostic and procedural codes.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Nancy Reynolds Howard, Consultant, NRH Compliance Partners
Recorded on: April 23, 2019
Description: Former FDA counsel John Fuson explains how to navigate FDA inspections. He discusses:
- Best practices for answering FDA Form 483 observations;
- Strategies for avoiding warning letters and serious enforcement actions;
- Tools for assessing company exposure to regulatory risk; and
- FDA factors that render enforcement or escalation.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: John Fuson, Partner, Crowell & Moring, LLP
Recorded on: April 18, 2019
Description:Dan Matlis and Mike Jovanis discuss the application of modern technologies to product lifecycle management. They cover:
- ICH Q12 and its potential benefits;
- How technology can support ICH Q12 and simplify change management; and
- Innovative ways leading pharma companies are addressing PACM.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Daniel R. Matlis, Founder and President, Axendia, and Mike Jovanis, VP-Vault Quality, Veeva Systems
Recorded on: April 4, 2019
Description: Quality systems expert Dan O’Leary explains the hybrid system where you maintain a device certificate under the MDD and a QMS under the MDR. He discusses:
- The dates from the EU-MDR for when the hybrid system can apply;
- The three elements from the MDR Chapter VII – post-market surveillance, market surveillance and vigilance;
- The role of device registration and the required data elements; and
- How to structure the technical documentation for the hybrid system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: April 2, 2019
Description: Compliance experts Cynthia Schnedar and Liz Oestreich offer recommendations on how to build and maintain a culture that values quality and supports data integrity in the manufacturing process. They discuss:
- Best practices in building a culture of quality — including compliance with WHO and FDA data integrity standards;
- The nuances in Commissioner Gottlieb’s statement on achieving drug manufacturing quality; and
- Tips on how to ensure employees are invested in maintaining quality and how to avoid passive non-involvement.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Cynthia Schnedar, Executive Vice President, and Liz Oestreich, Vice President of Regulatory Compliance, Greenleaf Health, Inc.
