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.

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Webinar Training Pass

Recorded on: Nov. 12, 2019

Description: Clinical research experts Kerry Dyson and Kris O’Brien share real-world case studies that show how patient engagement leads to successful data capture and better outcomes. They discuss:

  • How to approach project planning for the best outcomes in patient participation;
  • Case studies of successful patient engagement during actual trials;
  • Viewing patients as research partners and the steps needed to keep them involved; and
  • Sustaining engagement and motivation throughout a trial.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Kerry Dyson, Global Head of Clinical Research; Kris O’Brien, Vice President of Client Strategy and Development; CROMSOURCE

Recorded on: Nov. 5, 2019

Description: Design control statistical expert Steven Walfish shares best practices for understanding the requirements for statistical techniques and how they impact the design control process and sample size issues. He discusses:

  • How to appreciate the nuanced interpretations of 21 CFR 820.250;
  • How to recognize the differences between confidence and reliability in the sample size;
  • How to understand the importance of how data is collected and how to justify the sample size;
  • How to incorporate statistical assumptions as part of all sampling plans; and
  • How to grasp how variance in the population impacts the sample size necessary to establish objective evidence.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Steven Walfish, president, Statistical Outsourcing Services

Recorded on: Oct. 31, 2019

Description: Human error reduction expert Ginette Collazo shares best practices for minimizing human error and regulatory citations in manufacturing. She discusses:

  • How to prepare an outline and develop world-class SOPs;
  • The interrelationship between SOPS, quality and regulatory compliance;
  • Why human error is a root cause for lack of quality and how to minimize it; and
  • How to create and maintain a procedure that minimizes human error.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Ginette Collazo, chief executive officer, Human Error Solutions

Recorded on: Oct. 30, 2019

Description: Technology experts Jon Carter, Catie Roland and Mark Tomlinson share the differences between EDC and eSource and offer guidelines to help select solutions that suite clinical trial needs. They discuss:

  • Pros and cons of EDC vs. eSource;
  • The challenges of eSource adoption and pitfalls to anticipate and avoid;
  • When should EDC and/or eSource be implemented; and
  • Should EDC and eSource be combined in the same study.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Jon Carter, Product Manager; Catie Roland, Program Manager; Mark Tomlinson, Senior Director of Technology Operations; Cmed Technology

Recorded on: Oct. 29, 2019

Description: Regulatory expert Alan Minsk shares best practices for adhering to the recent Instruction for Use (IFU) guidance and expected implications on new drug applications and biologics license applications. He discusses:

  • How the current content and format for IFUs will need to be modified;
  • Examples of sample labeling that cover all elements of an IFU—from dosage and usage to storage and disposal;
  • Examples of the kind of recommendations the FDA makes in terms of design and layout; and
  • Practical considerations on patient labeling.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Alan Minsk, partner, Arnall Golden Gregory LLP

Recorded on: Oct. 15, 2019

Description: Device expert Connie Hoy shares best practices for responding to nonconformities found during an audit inspection. She discusses:

  • How to analyze the criticality of the audit findings;
  • How to avoid complicating the corrective actions and inadvertently overburdening organizations;
  • How to prioritize plans by identifying corrections and corrective actions;
  • How to write a sufficient corrective action and preventive action (CAPA) procedure; and
  • How to draft an appropriate response to the auditing agency.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Connie Hoy, Founder, Hoy & Associates Regulatory Consulting

Recorded on: Oct. 10, 2019

Description: Risk management expert Mark Levy shares best practices for having a solid process for compliance with current law and guidance in regard to medical product off-label use and marketing. He discusses:

  • The current law and guidance on off-label promotion and how it affects quality, regulatory and compliance professionals;
  • How to detect potential allegations of wrongdoing and how to deal with them;
  • The nuances of the False Claims Act and how the First Amendment intersects with claims; and
  • How to conduct an effective internal investigation when alleged unlawful off-label promotion is detected.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Mark Levy, Litigator and Trial Attorney, Eckert Seamans

Recorded on: Oct. 9, 2019

Description: Quality systems expert Dan O’Leary shares insights to help find solutions to the five highest-risk areas that prompt 483s and warning letters. He discusses:

  • The most commonly cited section in warning letters;
  • The distribution of warning letters by source, region and part;
  • The Forgotten Five — the bottom 5 of the top 10 — most cited observations;
  • The issues cited in the warning letters; and
  • How to address the issues before inspection.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: Oct. 9, 2019

Description: Technology expert Filip Matakovic shares best practices for making a paperless transition, including how updated guidelines and new technology have lowered the hurdles and streamlined the transition to going electronic. He discusses:

  • System compliance and audit readiness;
  • The costs and current methodologies of paper binder storage;
  • The advantages of managing documents electronically; and
  • eSignatures and Part 11 compliance.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Filip Matakovic, Vice President and General Manager, Site Services Group, MedPoint Digital

Recorded on: Oct. 8, 2019

Description: Regulatory experts Dirk Rodgers, Susanne Somerville and Joseph Lipari share best practices for staying up-to-date on the changing pharma regulatory landscape along with VRS solutions. They discuss:

  • The evolving serialization mandates for Russia, China, India and Egypt;
  • Blockchain and interoperability;
  • The saleable returns mandate.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Dirk Rodgers, Regulatory Strategist, Founder of RxTrace.com; Susanne Somerville, Chief Executive Officer, Chronicled; Joseph Lipari, Director, Cloud Products, Systech