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

GLP Compliance
69 minutes
Description: GLP compliance expert Anne Maczulak lays out a 10-step strategy for preparing to face FDA inspections, from developing SOPs to conducting mock inspections. Points covered include:
  • Developing a pre-audit assessment plan;
  • Elements of a safety policy; and
  • Roles and responsibilities for staff involved in the inspection.

Presentation: Download presentation

Speaker: Anne Maczulak PhD RQAP-GLP, Principal Consultant, Acorn GLP Consulting

Description: Compliance expert and former FDA investigator Martin Browning presents the EU’s revised rules for managing risks throughout the life of any computerized systems used in a regulated activity, from simple spreadsheets to complex networks. Annex 11, revised in 2011, is the European counterpart to U.S. Part 11 rules for use of electronic systems in manufacturing. Browning explains:
  • The principals and scope of Annex 11;
  • Differences between Annex 11 and Part 11;
  • How the revised rules incorporate standard IT practices; and
  • How they differ from the original Annex 11 provisions that had been in place for nearly 20 years.

Presentation: Download presentation

Handout #1 - Comparison of FDA’s Part 11 and the EU’s Annex 11

Handout #2Verification vs. Validation: FDA’s Expectations and Why The Difference Matters

Speaker: Martin Browning, President and Co-Founder, EduQuest

Description: Regulatory attorney Alan Minsk examines the impact of 10 key legal cases on the drug industry. Cases presented cover such issues as:
  • Reporting adverse events;
  • Patent ownership;
  • Labeling; and
  • Product liability.

Presentation: Download presentation

Speaker: Alan Minsk, Partner and Chair of the Food & Drug Practice Team, Arnall Golden Gregory LLP

Description: Elizabeth Garrard, Chief Safety Officer of the Drug Safety Alliance, explains how statistical signal detection can aid pharmacovigilance and offers tips on how to manage signal detection throughout the lifecycle of a product. Garrard covers:
  • What is – and isn’t – a signal;
  • Methods for identifying signals;
  • Data sources; and
  • ypes of questions that can be answered by using data mining methods.

Presentation: Download presentation

Speaker: Elizabeth Garrard PharmD. R.Ph., Chief Safety Officer, Drug Safety Alliance Inc.

Description: GMP consultant Steven Sharf explains how to address the risks associated with accepting suppliers’ certificates of analysis through regular auditing. Topics include:
  • Using risk management tools to determine which suppliers to audit;
  • Audit frequencies and schedules;
  • Qualifying suppliers for reduced testing; and
  • Tailgate sampling.

Presentation: Download presentation

Speaker: Steven Sharf, President, GMP Concepts

Description: John Gagliardi of Midwest Process Innovation LLC interprets the audit requirements contained in the one-paragraph Section 820.22 of the Quality System Regulations, discussing:
  • Creating a master audit schedule;
  • Establishing the scope of the audit;
  • Training personnel for inspections; and
  • Auditor qualifications and responsibilities.

Presentation: Download presentation

Speaker: John Gagliardi, President, MidWest Process Innovation LLC

Description: Quality and compliance experts David Chesney and Peter Smith of PAREXEL present best practices for data and document management, covering such topics as:
  • FDA authority to request certain documents;
  • Ensuring timely document retrieval during an inspection; and
  • Ten questions to ask to make sure a data and documentation management sytem will pass inspection.

Presentation: Download presentation

Speakers: David Chesney, Quality and Compliance Management Services Vice President, PAREXEL Consulting and Peter D. Smith, Vice President for Pharmaceutical Compliance, PAREXEL

Description: Clinical trial data specialist Peggy Schrammel demonstrates how to use patient registries to collect real-world effectiveness and safety data. Topics include:

Considerations for registry design;

  • Finding the most suitable data source/approach;
  • Using chart review studies to capture data retrospectively; and
  • Building effective registry teams.

Presentation: Download presentation

Speaker: Peggy Schrammel, VP-Registries and Post Approval Development, United BioSource

Description: PDR Network CEO Edward Fotsch discusses the transition to electronic health records as required by 2010 healthcare reform legislation. Fotsch covers:
  • How EHRs can cut the time and cost of communicating REMS elements;
  • Incentives the law provides for hospitals and providers, and penalties for those that don’t make the switch by 2015;
  • Information flow from drugmakers to providers through EHRs; and
  • Potential opportunities and liabilities.

Presentation: Download presentation

Speaker: Edward Fotsch M.D., CEO, PDR Network LLC

Description: Regulatory specialists Joan Antokol and John McLane examine the FDA guidance, “Safety Reporting Requirements for INDs and BA/BE Studies,” issued in draft form in 2010 and finalized in December 2012. Topics discussed include:
  • Differences in requirements for IRBs, sponsors and investigators;
  • Clarification of terminology in FDA regulations prior to 2010; and
  • Product liability risks.

Presentation: Download presentation

Handout Drug Withdrawls In The US

Speakers: Joan Antokol, Managing Partner, Park Legal LLC and Dr. John (Jack) McLane, COO, Clinquest Inc.