Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)

Use coupon code COMPLIANCE15 to get 15% discount on this virtual seminar Participants in this seminar will: Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations Understand how to select, qualify and monitor CMOs, CROs and Contract Laboratories Learn the elements to include in a quality agreement (also known as a technical agreement) Learn how to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsource Understand your obligations under the law for products you release to the clinic or the marketplace Appreciate the importance of maintaining data integrity Learn how to effectively manage a health regulatory inspection: Inspection logistics Responding effectively to document requests and questions from inspectors Managing the inspection exit discussion How to write an effective response to inspection observations ... Read more

Use coupon code COMPLIANCE15 to get 15% discount on this virtual seminar Participants in this seminar will: Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations Understand how to select, qualify and monitor CMOs, CROs and Contract Laboratories Learn the elements to include in a quality agreement (also known as a technical agreement) Learn how to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsource Understand your obligations under the law for products you release to the clinic or the marketplace Appreciate the importance of maintaining data integrity Learn how to effectively manage a health regulatory inspection: Inspection logistics Responding effectively to document requests and questions from inspectors Managing the inspection exit discussion How to write an effective response to inspection observations How to find applicable inspection references and procedures of the FDA, EMA and Health Canada