Quality/Compliance Management for Virtual Companies

Today, many companies operate on an outsourcing model. This is very common for companies with plans to have a product ready for market approval in the coming months. Most of these companies are small and may not have deep expertise in QA and GMP compliance,instead, relying on their partners to cover those areas.

In spite of the advantages of outsourcing, companies still remain responsible for the quality and compliance status of the products that enter the marketplace.

How can companies learn how to address the GMP needs of outsourced operations? In the new PDA Education course, “Quality and Compliance Management for Virtual Companies,” following the 2018 PDA/FDA Joint Regulatory Conference, will learn about U.S. FDA and other global regulatory expectations for these “virtual” companies. These expectations include diagnosing a company’s needs based on which GMP-governed operations are retained and which are outsourced, identifying best industry practices for selecting, qualifying and monitoring contractors to ensure they meet requirements and designing a quality system framework that has the structure and integration to “grow with the company” as the scope of operations changes over time.

Participants in this course will:

• Recognize the GMP requirements all virtual companies must meet regardless of the extent of their outsourcing operations
• Learn which elements to include in a quality agreement (also known as a technical agreement)
• Determine which GMP requirements apply to the contract giver
• Understand the legal obligations for products released to the marketplace
• Appreciate the importance of maintaining data integrity
• Learn what to expect from an FDA or other health regulatory inspection, including the usual scope of virtual company inspections and why they occur, effective responses to document requests and inspectors’ questions, the inspection exit discussion, effective responses to observations and applicable FDA, EMA and Health Canada inspection references/procedures.

Virtual companies may outsource responsibilities to others but still retain legal Responsibility for the outcomes. Compliance requires an understanding of which requirements apply to the company and which apply to vendors. Understanding those requirements assures that the company remains compliant and can better successfully manage the vendor relationship to assure product launch.