Why Should You Attend:
This training provides an overview of how FDA conducts inspections of Pharmaceutical firms and laboratories. Beginning with FDA’s expectations of the personnel, site and laboratories and then moving on to the SOP’s and documentation that they will expect to review.
This training also covers how to manage the inspection from the time the investigator appears at your door until finishing the closing meeting if in the US. Or if a preannounced international inspection, what to do from the time they contact you to set a date to when you finish the closing meeting
And finally, it covers the persons participating in the inspection and their various roles and organization. This way everyone is prepared in advance and more relaxed because they know what to expect.
Areas Covered in the Webinar:
Preparation of the site before FDA arrives
What to do when FDA arrives
Who Will Benefit:
All management and QA personnel working in the Pharma industry as well as SME’s and supervisory personnelInstructor Profile:
Marie Morin is an experienced former US FDA Drug Specialist with a demonstrated history of working extensively in the pharmaceuticals industry in the US and multiple other countries including: China, India, Germany, Italy, Austria, Ireland, France and the Netherlands to name a few. Now working as a consultant to help those in the Pharma industry be more comfortable with the FDA and help them be prepared for FDA inspections and expectations.
She is skilled at auditing a wide variety of manufacturers of: Sterile and non-sterile API's and Finished products, Good Laboratory Practice (GLP) Lab facilities, Biologically produced API and finished products and Medical Device manufacturers. With wide experience evaluating and improving documentation in relation to: Change Control, Deviations, Complaints, Investigations and CAPA as well as laboratory documents and raw data as well as OOS investigations. Well versed in Biotechnology, and Regulatory Requirements.
A strong business development professional with a BS focused in Health Sciences w/ 50 hr Microbiology concentration from East Tennessee State University.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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