The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
Recorded on: May 7, 2015
Description: Process and organization expert Ron Snee presents a holistic approach to QbD with a focus on enabling effective process development, quality improvement and compliant operations. Topics include:
- Why the FDA is focusing on QbD;
- How QbD benefits both sponsors and their CMOs;
- Best practices for understanding and reducing risk; and
- When and how to revise your SOPs, training programs and general culture to effectively deploy QbD in an organization.
Presentation: Download the presentation
Speaker: Ron Snee, Founder and President, Snee Associates
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: April 30, 2015
Description: Process expert Jerry Dalfors explains the intricacies of developing and improving batch production records and device history records. Topics include:
- Proven strategies for reducing employee errors;
- Best practices for writing BPRs/DHRs to assure they generate objective evidence;
- Developing Incident Tracking Systems that assure all incidents are recorded as they occur and noted properly within the lot packet; and
- Understanding the nine instructions given to FDA investigators regarding review of batch records.
Presentation: Download the presentation
Speaker: Jerry Dalfors, Principal, JD Technologies
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: April 29, 2015
Description: Dr. Rita Redberg and Dry. Sanket Dhruva discuss the problems presented by low participation of women as subject in clinical trials and offer strategies for reducing this gender disparity. Dr. Redberg discusses:
- The current status of women’s representation in clinical trials and sex-specific reporting of clinical trial data;
- Reasons for low participation of women in clinical trials; and
- Requiring gender-specific quality indicators in clinical trials.
Presentation: Download the presentation
Speakers: Rita F. Redberg MD MSc, Professor of Medicine and Director of Women’s Cardiovascular Services at UC-San Francisco and Chief Editor of JAMA Internal Medicine; Sanket Dhruva MD, Cardiology Fellow, UC-Davis Medical Center
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: April 28, 2015
Description: Device expert and inventor James (Rusty) Lusk demonstrates how to stress-test a CAPA program to identify and address any weaknesses. He covers:
- Understanding the most effective part of a CAPA system where the thought process and the documentation process overlap to truly produce results;
- How to identify and solve the 5 common CAPA problems;
- Using effective flow charts to determine when to trigger a CAPA; and
- Writing CAPA reports — with proper supporting documentation — that FDA investigators will accept.
Presentation: Download the presentation
Speaker: James (Rusty) Lusk, Principal, Quality Systems International
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: April 23, 2015
Description: Clinical trial regulatory expert Darshan Kulkarni provides an overview of the FDA guidance on risk-based monitoring of clinical trials. He covers:
- Developing a centralized risk-based approach;
- Factors to consider in developing a monitoring plan; and
- Communicating monitoring results.
Presentation: Download the presentation
Speaker: Darshan Kulkarni, Kulkarni Law Firm, PC
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: April 16, 2015
Description: Aseptic systems expert Herman Bozenhardt explores modern technologies of facility redevelopment that can extend the life of a facility by 10 -20 years and enhance compliance. He discusses:
- How unidirectional flows and architectural layout can boost productivity;
- How to use automation and portable systems to deliver product faster; and
- The top operational upgrades in material handling that every manufacturing professional should know.
Presentation: Download the presentation
Speaker: Herman Bozenhardt, Bozenhardt Consulting Services, LLC
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Description: Subject matter expert Deborah Kacera walks you through the processes you need to take to secure a production account for submitting electronic Medical Device Reports (eMDRs), ahead of an Aug. 14, 2015 deadline for compliance including:
- How to understand the three very different ways to transform your data into an XML file
- How to become a "transaction partner" with the FDA
- Ways to leverage the ACK (Acknowledgements) process to demonstrate compliance with the FDA
- How to steer clear of deadline and other time-related problems
Presentation: Download the presentation
Speaker: Deborah Kacera, Regulatory and Industry Strategist, Pilgrim Quality Solutions
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Description: Recall experts Willie R. Bryant and Chris Harvey show you how to assess your current recall plans to see if they'll really work when you put them into action. Specifically:
- To recall or not? Your policies should tell you how to decide when a recall is required.
- Necessary Resources. Who you have to contact and how to reach them if you decide to implement a recall.
- FDA Compliance. Your communications with the FDA must occur within certain periods and meet very specific requirements.
- Conducting Mock Recalls. Get tips from the pros and the benefits and takeaways of thoroughly testing your recall readiness.
- 10 Lessons from the Field. Every recall is different, with some similarities in the types of things that can go wrong.
Presentation: Download the presentation
Speakers: Willie R. Bryant, Expert Consultant, Stericycle ExpertSOLUTIONS and Chris Harvey, Recall Strategist, Stericycle ExpertSOLUTIONS
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Description: Quality system expert Susan Reilly shows why internal audits should be used as a proactive tool and not just as a reaction to an FDA regulatory requirement. Topics include:
- How to identify and understand the FDA's exact requirements;
- How to determine if your organization follows its own procedures and maintenance programs;
- How to identify specific areas of waste, expense or effort when examining an existing internal audit program; and
- How to "score" your current system just as an FDA inspector would.
Presentation: Download the presentation
Speaker: Susan Reilly, Reilly Associates, LLC
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Description: Quality consultant Crystal Mersh helps quality control and assurance professionals understand the critical role that the Quality Control Unit (QCU) plays in ensuring regulatory compliance. Topics include:
- Nine critical expectations of the QCU;
- An 8-year historical breakdown of quality control citations; and
- Four best practices for ensuring you're managing an effective QCU.
Presentation: Download the presentation
Speaker: Crystal Mersh, Co-founder and President, Quality Executive Partners, Inc.
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.