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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Webinar Training Pass
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Description: Legal expert Rachael Hunt shares best inspection practices and examines the new draft guidance on requesting FDA advice on remedying Form 483 findings.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: March 29, 2019
Description: IRB official Kristin J. Craun clarifies key aspects of the revised Common Rule and approaches for educating research teams and ensuring compliance. She discusses:
- How new exempt categories may reduce obligations in human subject protection;
- How new required elements of consent change the standards for informing patients and obtaining consent;
- How the use of continuing review policies apply to minimal risk research and its effect on daily responsibilities in managing clinical trials; and
- How the new Common Rule requirement allows flexibility in some clinical trial areas and the key factors in determining when and how this flexibility can be utilized.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kristin J. Craun, Senior Director, Institutional Review Board, University of Southern California
Note: Due to technical issues, the first 2 minutes of this recording is missing.
Recorded on: March 28, 2019
Description: Cell and gene therapy expert Scott R. Burger discusses the FDA’s requirements for biologics license applications, common mistakes applicants make and how to avoid them. He covers:
- How a cell or gene therapy BLA fits into the framework of the CTD;
- What reviewers in the Office of Tissues and Advanced Therapies expect to see in a BLA; and
- How the earlier stages of development affect the content of the BLA.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Scott R. Burger, Principal, Advanced Cell and Gene Therapy