SOURCE: Xtalks

Xtalks Webinars

November 17, 2015 09:11 ET

FDA Inspections, 483s and Warning Letters, Oh My!

Virtual Training Workshop Offers -- FDA Inspections: Simulated Environment of a Clinical Trial Response Team -- What Would You Do?!

TORONTO, ON--(Marketwired - November 17, 2015) - Xtalks eCademy launches a special two-hour virtual training workshop to help clinical research teams, from both study sites and sponsors, better understand and respond appropriately to an audit or FDA investigation of their clinical trial.

  • Online Workshop: Wednesday, December 9, 1:00 - 3:00 pm EST

Proper preparation for audits and FDA inspections require an intimate knowledge and understanding of the regulations, as well as awareness of the repercussions, including Form 483s, warning letters, or worse, should your organization be noncompliant. And without prior experience with real-world inspections, it can be difficult to know if your site will pass scrutiny.

This highly interactive online workshop will help reduce 'fear of the unknown' by teaching participants what to expect in an audit or FDA inspection as well as the skills and tools needed to best respond to any findings and avoid further actions.

Janet Holwell, approved trainer for the ACRP and instructor in good clinical practice (GCP), will use real-world case scenarios in an interactive format to help solve the dilemmas faced by both sites and industry when faced with discoveries from regulatory authorities or auditors.

Interactive exercises will be incorporated utilizing FDA Warning Letters where participants will learn how to perform root cause analysis (RCA) and prepare realistic and appropriate corrective and preventive actions (CAPAs) to resolve, or avoid, further actions by regulators. Standard Operating Procedures (SOPs) and GCP will also be part of the discussion in response to FDA warning letters the group will be assigned during the training.

"I think it's critical to participate in these types of workshops
so you can get feedback, ask questions and get input from colleagues around the globe.
That experience gives a lot more depth of understanding
than just reading the regulations and how to apply them."
Janet Holwell, CCRC, CCRA, TIACR

Practical, convenient, engaging and fun, this virtual workshop can be accessed from your home or office and is equipped with real-world experience and armed with the latest tips, tools and best practices to ensure you and your teams' ongoing success. Registrants will have the opportunity to participate in online polls and engage with fellow participants, with frequent key learning concepts reinforced throughout the training, followed by an interactive Q&A session. Participants will earn a Certificate of Completion equal to Education Credits of 2.0 post training.

Instructor: Janet Holwell, CCRC, CCRA, TIACR has over 30 years' experience as both an academic and industry Clinical Research Professional. Now as an independent consultant, she specializes in maximizing excellence in GCP quality, compliance and training for both sites and industry. She is a founding member and recent-past President of the New York Metropolitan Chapter of ACRP (Association of Clinical Research Professionals).

Xtalks eCademy: Interactive Online Training Courses and Workshops:
Developed through ongoing research and in-depth dialog with your peers, Xtalks eCademy provides a unique, best-in-class virtual learning experience for companies and individuals who wish to stay informed about recent developments in the life science industry. Our interactive online training courses are delivered by pharmaceutical, biotech and medical device industry experts to equip you with the knowledge needed to excel in your field of interest.

Register today and take the first step to ensuring audit and FDA inspection success!

For more information, visit: http://xtalks.com/eCademy.ashx

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