Quality Agreements For Contract Manufacturing Operations
60 Minutes
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.
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.
AREA COVERED
- 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
WHO WILL BENEFIT?
- Quality Assurance
- External Manufacturing/Outsourcing
- Regulatory Affairs
- Compliance
- Purchasing
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.
- 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
- Quality Assurance
- External Manufacturing/Outsourcing
- Regulatory Affairs
- Compliance
- Purchasing
Speaker Profile
John Misock 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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