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.
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.