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

Description: Industry expert Brian Dense assesses the strengths and weaknesses of off-the-shelf quality systems against custom solutions, providing real-world case studies that highlight the best and worst of each approach. He also focuses on avoiding several common errors when choosing the best approach, including:
  • Misunderstanding the purpose of a quality system;
  • Misunderstanding regulatory requirements of the market; and
  • Failing to understand that quality is a department, not an integrated practice.

Presentation: Download the presentation

Speaker: Brian Dense, President, CiNQ Systems

Description: SOP analysts Steven Steinbrueck and Elizabeth Bodi share ways to shorten and focus SOPs, demonstrating how to spot and prevent common mistakes, including:
  • Dictating how to accomplish a task;
  • Mandating dates; and
  • Including things that are not regulatory requirements/expectations, senior management mandates or accepted best practices.

Presentation: Download the presentation

Speakers: Steven Steinbrueck, President, Stonebridge GCP Consulting and Elizabeth Bodi, Clinical Research Senior Consultant, Halloran Consulting Group

Description: Industry analyst Thomas Peither covers important ground on the many changes to EMA drug process validation. Peither discusses:
  • Why validation should be carried out in accordance with GMP;
  • The need for a minimum of 3 validation batches; and
  • Basing the number of batches on the variability of the process, the complexity of the process/product, and the experience of the manufacturer

Presentation: Download the presentation

Handout #1: Synopsis: FDA Process Validation Guidance

Handout #2: Guidance for Industry, Process Validation: General Principles and Practices

Handout #3: Note for Guidance on Process Validation

Handout #4: European Medicines Agency: Draft Guideline on Process Validation

Handout #5: Comparison Between EMA and FDA On Traditional Process Validation Approaches

Speaker: Thomas Peither, President, Maas & Peither America Inc.

MDUFA 2012
78 minutes
Description: Noted expert and former FDA official Steven Niedelman is joined by legal analyst Pamela Forrest  to provide detailed insight on the 2012 MDUFA reauthorization, device user fees, FDA performance goals, and other key provisions affecting medical devices, including:
  • Conflict of interest scenarios;
  • Patient participation in product discussions; and
  • Nanotechnology issues.

Presentation: Download the presentation

Speakers: Steven Niedelman, Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences practice team, King & Spalding and Pamela Furman Forrest, Partner, King & Spalding

Description: An expert legal team maps the complex PDUFA V requirements. Topics covered include;
  • The path to market provisions;
  • Distribution and supply provisions;
  • User fees and performance goals.

Presentation: Download the presentation

Speakers: Peter Barton Hutt, Senior Counsel, Covington & Burling; Erika Lietzan, Partner, Covington & Burling; Scott Cunningham, Partner, Covington & Burling and Stefanie Doebler, Special Counsel, Covington & Burling

Description: On July 3, 2012, the FDA released a proposed rule on the unique device identification (UDI) system, ending a year-long delay in finalizing the much-anticipated safety mechanism. The 165-page comprehensive rule touches all aspects of the medical device industry. The FDA maintains that the UDI system helps reduce the rate of death caused by faulty devices, which the agency estimates at 17,700 over the past five years. Jeffery Shuren, director of CDRH, called the UDI rule "a major game-changer." The FDA receives numerous device-related adverse event reports, but often can't tell what device the patient is referencing. UDI makes aggregating reports easier, but at what time and cost to industry? Across the board — from supplier, provider, distributor, to consumer — who is ready? Listeners will learn what's hidden in the rule's 165 pages and where to start the journey to implementation. Siobhan O'Bara and John Roberts of GS1 will provide clarification on creating a mandatory system of unique device identifiers.

Presentation: Download the presentation

Speakers: Siobhan O'Bara, Healthcare Vice President, GS1 US and John Roberts, Director of Healthcare, GS1 US

Description: In this webinar, legal analyst Ed Dougherty shows how to:
  • Develop a single, integrated regulatory/market access strategy and point of contact;
  • Conduct an early landscape assessment to develop a milestone-driven strategic plan; and
  • Create a new gap analysis technique to evaluate assets, determine what to leverage and what to build; and
  • Update a reimbursement strategy to anticipate new market dynamics.

Presentation: Download the presentation

Speaker: Ed Dougherty, Senior Healthcare Advisor, Arent Fox

Description: Regulatory experts James Ravitz and Stephanie Trunk dissect regulations governing off-label promotion. Topics covered include:
  • Key areas of risk and potential red flags;
  • Responding to public and non-public unsolicited requests for information;
  • Implications of the responsible corporate officer doctrine; and
  • How a violation becomes a false claims case.

Presentation: Download the presentation

Speakers: James Ravitz, Partner, Arent Fox LLP and Stephanie Trunk, Associate in the Health Law Group, Arent Fox LLP

Description: Leading legal analysts Erika Lietzen and Laura Sim deconstruct the FDA’s biosimilars guidance and the comments it received and what FDA enforcement and emphasis might look like in the future.  They also highlight important areas the guidance doesn’t address, such as:
  • Pediatric testing; and
  • When a regulated entity should construct its own defensible compliance programs instead of waiting for overt FDA direction.

Presentation: Download the presentation

Speakers: Erika Lietzen, Partner, Covington & Burling and Laura Sim, Associate in Food & Drug practice group, Covington & Burling

Description: A trio of legal experts guides devicemakers through the 510(k) process, focusing on:
  • How to better understand and produce  compliant 510(k) content;
  • How to handle a predicate event; and
  • How to understand when a regulated entity should issue a 510(k).

Presentation: Download the presentation

Speakers: Neil O'Flaherty, Principal, Olsson Frank Weeda Terman Matz PC (OFW Law); Evan Phelps, Principal, OFW Law and Nancy Mathewson, Associate, OFW Law