Quality Agreements For Contract Manufacturing Operations
Speaker : JOHN MISOCK
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John is serving in his fourth career as Senior Consultant with Ceutical Labs, Inc. Flower Mound, TX. John retired from the FDA’s Office of Cosmetics and Colors in June 2019 where he served as an SME in the areas of personal care product microbiology and manufacturing (GMP’s). Prior to FDA John served in a global capacity with Estee Lauder Companies responsible for regulatory compliance in all manufacturing facilities. In 1982 John took over the helm of Food and Drug Standards Manager for the State of Wyoming Department of Agriculture, where he became an internationally recognized leader in the adaptation of HACCP principles to regulatory programs. John was promoted to Deputy Commissioner of Agriculture prior to leaving for Este Lauder.
John Grew up on a farm in Ohio where he learned a great deal about self-reliance, resilience, and creativity. Leaving the farm to start his journey, John graduated from The Ohio State University and the University of Wyoming. The skills that John learned in those early years bring him to you today. If you have a chance, ask John about his experience as a shepherd in Wyoming’s Big Horn Mountains. John is also a musician and vocalist, something he has enjoyed since performing professionally at age 16.
It is important for contract manufacturing operations, whether they are in the cosmetic, drug, or device industries to have a Quality Agreement in place. This webinar will teach you what a Quality Agreement is, why you need a Quality Agreement, where and when Quality Agreements are needed, and who should prepare, review, and approve a Quality Agreement.
- What is a Quality Agreement?
- What should be included in a Quality Agreement?
- Why do you need a Quality Agreement?
- When is a Quality Agreement needed?
- Who should prepare, review, and approve a Quality Agreement?
- Responsibilities of the owner vs. contract manufacturer
- GMP responsibilities
Course Level - Beginner or Intermediate
Who Should Attend
Quality Assurance, External Manufacturing/Outsourcing, Regulatory Affairs, Compliance, Purchasing.
Why Should You Attend
Do you know what a Quality Agreement is? Do you know what should be included in a Quality Agreement? Do you know why you need a Quality Agreement? Do you know when a Quality Agreement is needed? Do you know who should prepare, review, and approve a Quality Agreement? Do you know what the responsibilities of the over vs. contract facility are? FDA is looking for Quality Agreements during inspections.
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