Quality Agreements For Contract Manufacturing Operations
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
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.
- Quality Assurance
- External Manufacturing/Outsourcing
- Regulatory Affairs
- Compliance
- Purchasing
John Misock is serving in his fourth career as Senior Consultant with Ceutical Labs, Inc. Flower Mound, TX. He provides regulatory consulting services across all FDA-regulated industries. John retired from FDA in June 2019 where he was an SME in microbiological compliance and manufacturing. Prior to FDA John served in a global capacity with a multinational company responsible for regulatory compliance in all manufacturing facilities. Early in his career, John was Director of a state Food, Drug, and Cosmetics program and also served as Assistant Commissioner of Agriculture.
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