In this FDA inspection webinar attendees will learn the regulatory requirements for all FDA-regulated products. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. It will also highlight why the prudent firms needs to prepare them self for such inspections.
All manufacturers of FDA-regulated products, including drugs, foods, cosmetics, medical devices and veterinary products, are subject to the requirements to FDA inspection. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. The prudent firm will prepare itself for such inspections, using methods such as those to be discussed in this webinar. While this webinar will focus on pharmaceutical requirements, the concepts to be discussed will be applicable to all FDA regulated products.
This webinar will give employees concepts that they can apply to their particular firm in preparing for FDA inspections. It is prudent for all FDA-regulated firms to appoint a group of employees to prepare for FDA inspection. The members of this group require training in how to prepare for an FDA inspection. The consequences of a “failed” FDA inspection (one classified by FDA as OAI) can be quite severe.Areas Covered in the Webinar:
Regulatory Compliance Consultant (Ex-FDA Official)
Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She participated in the development of method validation requirements for HPLC analytical methods. She then transitions to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.
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. FDATrainingAlert 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.
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