The Webinar Training Pass

The 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.

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.

Many of our 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: Attorney Joan Antokol explains how to ensure the right language is written into a clinical trial agreement indemnification clause to protect the sponsor in the event a malpractice lawsuit is filed. Using case studies and examples of clauses from actual clinical trial agreements, Antokol examines:
  • The impact of the current research landscape on indemnification;
  • IRB and Ethics Committee requirements; and
  • Factors to consider when deciding the scope of indemnification needed for a clinical trial.

Presentation: Download presentation

Speaker: Joan Antokol, Managing Partner, Park Legal LLC

Description: Quality and organization expert Dan O’Leary presents the elements of an integrated complaint management system that functions effectively and meets FDA requirements. O’Leary covers:
  • Mapping the process flow in an integrated complaint management system;
  • Servicing records and reports;
  • Recording and reporting on complaint investigations; and
  • Overlapping reporting requirements for MDRs and Corrections & Removals.

Presentation: Download presentation

Speaker: Dan O’Leary, President, Ombu Enterprises LLC

A World Apart
90 minutes
Description: International compliance experts Steven Datlof and Elisabethann Wright examine the differences between medical device reporting requirements in the EU and the U.S., addressing who needs to report adverse events, when they should be reported and to what authority? Datlof and Wright look at:
  • The differences from the perspectives of manufacturers, user facilities and importers;
  • Premarket and postmarket reporting requirements; and
  • Reporting voluntary recalls and corrections and removals.

Presentation: Download presentation

Speakers: Steven Datlof MD JD, Partner, Hogan Lovells and Elisabethann Wright BL, Partner, Hogan Lovells International

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