MWSQA Webinars

MWSQA Webinar: You Don't Get a Second Chance to Make a First Impression: Ensuring Effective Responses and Avoiding Potential Pitfalls

Presented by Steven Niedelman, Consultant at King & Spalding

Thursday, 17 October 2019, 12:00 PM-1:00 PM EDT

You don’t get a second chance to make a first impression when responding to FDA-483s and Warning Letters. It is in your firm’s best interest to effectively respond to inspectional observations and Warning Letter cites (this doesn’t sound right – instead of cites, citations?) to reduce the risk of further escalation. It is important that your response provides the background and steps taken by your firm to effectively address systemic, as well as specific, examples of concerns and ensure planned actions are successfully completed in a timely and effective manner.
 
During this webinar, you will learn what FDA looks for in your response, as well as steps you can take to ensure that you are responsive to addressing their concerns and develop an effective response. This will include a tried and true template for developing your response, and tracking progress toward completion through subsequent FDA updates. We will discuss common pitfalls and how to avoid them. The importance of Developing an effective response will improve FDA’s impression of your quality system and reduce the risk of FDA escalation.

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Please check back for more announcements about webinars that are periodically offered by MWSQA.

View recordings from past MWSQA webinars below. MWSQA webinar recordings and PDF slides are free for MWSQA members. However, they must be "purchased" for $0.00 to add them to your "My SQA Online Education" button on your My SQA page. (You must log in to access this page.) Recordings and PDF slides may be purchased by non-members for a small fee. Follow the links on the webinar titles below to see more details and purchase the webinar.

Past Webinars

 

18 July 2019 Sponsor Oversight in Clinical Trials of IMP (Not recorded)
Presented by Mandy Budwal-Jagait
31 May 2019 Advanced Auditing for Data Integrity (Recording available soon)
Presented by Joy McElroy
22 March 2019 Going Beyond Warning Letters to Determine FDA Compliance Action Trends
Presented by Michael de la Torre
15 November 2018 A Six-Stage Business Continuity and Disaster Recovery Planning Cycle
Presented by Jack Cook
27 August 2018 Using Central Statistical Monitoring for Real-Time Detection of Fraud in Clinical Trials
Presented by Marc Buyse
21 May 2018 Deviation Management - Why Have We Not Solved the Problem?
Presented by David W. Husman
19 March 2018 Auditing Field Drift Studies (Aerial & Ground) and Field Volatility Studies Using GLPs
Presented by Kim Watson

7 November 2017 

Common Misunderstandings Surrounding US and International GLPs
(previously recorded SQA member-wide webinar from 29 October 2015)
26 July 2017 Introduction to Lean 5S for Quality Systems
Presented by Sami Abdul-Samad and Jeanette Guenther