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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.Areas CoveredWhat 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 manufacturerGMP responsibilitiesCourse Level - Beginner or IntermediateWho Should AttendQuality Assurance, External Manufacturing/Outsourcing, Regulatory Affairs, Compliance, Purchasing.Why Should You AttendDo 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.

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.

Areas 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

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.