Attend this webinar to get a perspective into the regulatory requirements of the FDA, EU, and ICH about the components of a change control program.
Pharmaceutical and medical device companies are required by the regulatory agencies to have in place a systematic approach to managing all the changes to their facilities, products, or a quality system. Knowing that changes are unavoidable, it is necessary that companies have an effective change control program that is compliant so that no needless or cGMP non-compliant changes take place. This webinar is designed to help.Learning Objectives:
At the completion of this course, attendees will be able to:
Topic 1: Regulatory Guidance Review
Topic 2: Review all Elements of a Change Control Record
Vice President, Americas Quality Operations
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
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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