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: 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.

Description: Former top FDA investigator Martin Browning examines best practices for making outsourcing decisions and navigating FDA regulations. Topics include:
  • Selecting suppliers with compatible standards and principles;
  • Providing information on suppliers to the FDA;
  • Contracts and Service Level Agreements; and
  • Continuing improvement of a supplier management system.

Presentation: Download presentation

Speaker: Martin Browning, Founder and President, EduQuest

Description: Quality assurance expert Jim Darnell explains how to negotiate, draft, implement and audit supply quality agreements with warehouses and shippers. Darnell discusses:
  • How to accommodate the complexity of the warehousing and logistics process in a quality agreement;
  • Special considerations, such as cold chain control and handling controlled substances;
  • How to define metrics and monitoring methods.

Presentation: Download presentation

Speaker: Jim Darnell, Managing Consultant, Tunnell Consulting

Description: Expert statistician Robert Thiel offers step-by-step instruction for using the Bayesian statistical method in device clinical trials. Thiel covers:
  • How the Bayesian method differs from the more commonly used Frequentist approach;
  • Benefits and costs of using the Bayesian method;
  • Basic probability laws; and
  • Examples of the method’s practical application.

Presentation: Download presentation

Speaker: Dr. Robert Thiel, Founder and CEO, THIEL Statistical Consultants

Description: Information management expert Antoinette Azevedo explains FDA requirements for Structured Product Labeling and offers strategies for compliance. Azevedo covers:
  • Data sharing using SPL;
  • Information workflow; and
  • echnology requirements and timeline for establishing an SPL system.

Presentation: Download presentation

Speaker: Antoinette Azevedo, Founder, e-SubmissionsSolutions.com