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.
BUY NOW Single-User 1-Year Unlimited Access $1,362
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.
Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Russ Titsch, Business Development Director at russ.titsch@wcgclinical.com or +1 703.538.7651 to receive a custom quote.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.
Webinar Training Pass
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.
Description: GMP consultant Rich Yeaton presents the latest tactics for handling an FDA inspection, including:
- How to handle FDA document requests.
- Tips for writing roadmap documents for investigators that cover major systems and processes.
- How to know when a FDA inspector is "testing" you with a particular on-site request.
- How to ask questions during the inspection that give you a good sense of how it's going without angering or putting the inspector on guard.
Presentation: Download the presentation
Speaker: Rich Yeaton, President, Atlantic Technical and Validation Services
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: Device packaging expert Abhi Gautam presents a case study-driven model for leveraging a risk-based packaging approach to prevent recalls and nasty audits. Topics include:
- How to identify the most important flaws or shortcomings in your medical device packaging program;
- How to show an FDA investigator that you understand the agency's packaging requirements; and
- What FDA investigators consider when they're debating if it's time to recall your product.
Presentation: Download the presentation
Speaker: Abhishek (Abhi) Gautam, Manager of Packaging Engineering, ConMed
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 Regulation expert Mike Heyl presents a proven five-step process to assure the FDA finds your purchasing controls sound — and most importantly — you have a system to assure ongoing compliance. He discusses:
- How to determine, and defend, the level of control selected for each product;
- Proven strategies to establish and maintain records acceptable to the FDA; and
- Specific tools and tactics to establish and maintain procedures for defensible acceptance activities.
Presentation: Download the presentation
Speaker: Mike Heyl, Partner, Hogan Lovells
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: Regulatory expert Rita King explains the requirements of IEC 62304 for all electromedical devices where basic safety or essential performance is dependent on software or firmware. She discusses:
- How to identify the two biggest pitfalls: documentation and software pedigree;
- How to understand and address three key noncompliance factors: software partitioning, document development and version control/updates; and
- How to write a Test Report Form that will stand up to FDA scrutiny.
Presentation: Download the presentation
Speaker: Rita King, CEO, MethodSense
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: Device attorney Jodi Scott advises devicemakers on handling FDA inspections, covering such topics as:
- How to advocate for your company in the post-inspection environment;
- 29 tips for what to do once an investigator shows up for an inspection; and
- Responding properly to a Form 483.
Presentation: Download the presentation
Speaker: Jodi Scott, Partner, Hogan Lovells
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: Life sciences attorney Stacie Ropka provides an analysis of FDA oversight of HCT/Ps, with a focus on what the draft guidelines mean for the future of regulatory scrutiny. She discusses:
- The FDA's position on when a HCT/P constitutes a drug/device and what resulting requirements need to be fulfilled;
- How the courts have interpreted "minimal manipulation;" and
- What processes in the draft guidances constitute some of the acceptable forms of minimal manipulation.
Presentation: Download the presentation
Speaker: Stacie Ropka, Counsel, for Axinn, Veltrop & Harkrider, LLP
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.