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

This webinar is on hold for future date. If you are interested in this webinar,
Please contact our customer care team 510-868-1040.

Speaker Profile

ins_img 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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