ComplianceOnline Virtual Seminar - Controlling Outsourcing Using Quality Principles - For Lifesciences Companies

Why Should You Attend: The FDA has begun to more closely scrutinize the control of outsourcing for biologicals, pharmaceuticals, and medical devices. In the Quality Systems Approach to Pharmaceutical GMP, the FDA defines outsourcing as involving hiring a second party under a contract to perform the operational processes that are part of a manufacturer’s inherent responsibilities. The International Conference on Harmonization (ICH), and the Global Harmonization Task Force (GHTF) standards also include requirements for outsourcing. The qualification of contractors for outsourcing is much more comprehensive than that required for suppliers. The same principles apply to all medical products.

Many virtual companies tend to shift responsibility from themselves to the contractor for compliance to regulatory requirements. They are often too willing to relinquish the required control over their valuable income producing assets to outsiders.

This course will help you understand your responsibilities so that you avoid regulatory problems or customer alienation that can damage your products reputation.

Areas Covered in the Seminar:

• Advantages and Disadvantages Of Outsourcing.
• The search for Qualified Contractors.
• Researching, auditing, evaluating, establishing corrective actions, and qualification of contractors.
• Establishing and maintaining control of personnel, equipment, material, process s, and technology.
• Writing the Contract and Quality Agreement-Establishing responsibilities.
• Maintaining Confidentiality.
• Technology Transfer-Laboratory and/or Production.
• Auditing the first run.
• Assuring process validation.
• Product Release.
• Establishing and Maintaining reliability of the contractor’ s results.
• Stability Testing.
• Maintaining Quality Requirements.
• Certificates of Analysis.
• Distribution Choices.
• The Use of Subcontractors By the Contractor.
• Product Salvaging.

Learning objectives:

• Understand how you can protect your product during outsourcing
• Understanding FDA expectations for the control of outsourcing
• Differences between contract testing and product manufacture
• Establishing good relationships

Free Handouts:

Diagrams explaining the subject matter will be provided.

Who Will Benefit:

This webinar will provide valuable assistance to all companies, especially, virtual companies who outsource the testing, manufacturing, and storage of their products / manufacturing sites.For contractors, it would help them understand their responsibilities and to gain insight into how the FDA view contractors.

Howard, enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

During experience described above, Mr. Cooper has implemented full supplier qualification systems and programs. This includes both consulting and employee roles.