2-Day Virtual Seminar Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

Seminar:2-Day Virtual Seminar Quality and GMP Compliance for Virtual Companies(Pharmaceutical and Biologics Industries) When:Thursday & Friday July 15-July 16,2021 DAY 01 & 02 (11:00 AM - 3:00 PM EST).

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Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering later stages of Phase 2 or Phase 3 clinical trials and plan to have a product ready for market approval in the coming months. Most such companies are small, and may not have deep expertise in QA and GMP compliance, relying on their partners to cover those areas. Companies that outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOS), Contract Research Organizations (CROs), and Contract Laboratories, however, remain responsible for the quality and compliance status of the products they send to the clinic or to the marketplace.

Learning Objectives:

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