Technology Transfer and Validation for Medical Devices and Pharmaceuticals: The Link between Development, Validation and Commercial Production

Why Should You Attend:

This webinar will discuss the concepts of technology transfer and validation as they relate to the commercial production of medical devices and pharmaceuticals. Research and development (R&D) activities are not regulated; however, the outputs from R&D serve as the launching pad for the manufacturing processes. Technology transfer is the term that applies to all the activities from the product and/or process development phases which serve as inputs to commercial manufacturing.

The regulatory requirements for incorporation of technology transfer into validation and commercial production have evolved throughout the decades. The outputs from product/process development, including the identification of critical quality attributes and critical process parameters, should be clearly defined in a well-executed technology transfer program in order to develop a validation strategy that assures a successful product launch and conformance with safety, quality, potency, and purity and effectiveness requirements throughout the product lifecycle. Technology transfer is dependent on and defined by the type of product; therefore, a dedicated, product-specific plan is recommended. Example of the content of technology transfer plans will be provided in this training as well.

Learning Objectives:

• Key concepts for creating a model or program for technology transfer
• Incorporation of technology transfer into the validation strategy
• Process monitoring as evidence of maintaining the state of validation

Areas Covered in the Webinar:

• International regulatory requirements for technology transfer and validation
• Link between the development and validation phases
• Process design as input to the validation program
• Process performance as output from the validation program
• Process monitoring as a means to demonstrate the state of validation

Who Will Benefit:

This webinar will be of interest to professionals in early or middle phase in their careers in research and development, product development, manufacturing or validation in the pharmaceutical or medical device industries. Professionals interested in a refresher course on the concepts of technology transfer and validation will also benefit. Participants will include:

• Quality Engineers
• Manufacturing Engineers
• Validation Engineers
• Validation Technicians
• R&D and Product Development Engineers and Scientists

Instructor Profile:

Carlos A. Rodriguez-Garcia, PhD, ASQ CSSGB, CBA, is president of BioMed Pharma Consulting, LLC, an independent consulting firm providing services in quality management systems to the pharmaceutical and medical device industries. Mr. Rodriguez-Garcia has over 18 years of experience in the regulated industry, the vast majority in quality management, encompassing a wide scope of products and processes in medical devices and pharmaceuticals: plastics, parenterals and aseptic processes. His experience includes writing, approving and executing validation protocols and collaborating with engineering and R&D in technology transfer.

Topic Background:

A successful technology transfer is proven through the successful completion of validation. The most recent validation model, recommended in FDA Validation Guidance, is comprised of:

• Process design: The link between development and production
• Qualification: The evidence to confirm the robustness of the process
• Monitoring: To demonstrate the validated state

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