Thursday, October 23, 2008
9:00 AM - 5:00 PM (Lunch 12:00 PM - 2:00 PM)
| Session 300 - Advanced Good Manufacturing Practices, 21 CFR 820 |
Instructors: Thomas Dzierozynski, Avarent
This session will provide attendees with the following:
- Overview of current regulatory and quality trends
- Process-based methodologies to synchronize business goals with compliance needs
- Decision making based on quality systems, risk and regulatory directives
- Understanding and dealing with post-launch activities
- Industry case studies and application benchmarking
Specific topics discussed will include:
- Quality System Improvement Programs
- Risk-based Approaches to Compliance
- Supplier/Vendor Quality Management
- Post-process Validation (Service and Supply Chain)
- Design Change Control
- Training and Competency
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Advanced Good Manufacturing Practices 21CFR 820anced Good Manufacturing Practices, 21 CFR 8
Abstract
FDA is responsible for advancing public health by helping to speed innovations that make products more effective, safer, and more affordable. It is the Agency’s intent to integrate quality systems and risk management approaches into existing programs with the goal of encouraging the adoption of modern and innovative manufacturing technologies. The elements that make up this approach inherently address the requirements of 21 CFR, Part 820, Quality System Regulation, but need to be aligned within each company’s business practices to assure successful product development and manufacture. This session will provide attendees with the following:
- Overview of current regulatory and quality trends
- Process-based methodologies to synchronize business goals with compliance needs
- Decision-making based on quality systems, risk and regulatory directives
- Understanding and dealing with post launch activities
- Industry case studies and application benchmarking
Specific topics discussed will include:
- Quality System Improvement Programs
- Risk-based Approaches to Compliance
- Supplier/Vendor Quality Management
- Post-Process Validation (Service and Supply Chain)
- Design Change Control
- Training and Competency
About the Instructor
Thomas Dzierozynski, Industry Consultant, Avarent
Mr. Dzierozynski has over 19 years experience in providing executive leadership to clients challenged in balancing the needs of business with the requirements of FDA regulations. Through comprehensive and practical knowledge of engineering principles and quality system approaches, he developed and implemented tailored strategies integrating varying business functions to drive ownership of the solution and change operational and quality performance of the organization. He has led numerous, technically-oriented projects focused on engineering design, commissioning, validation, process improvement, increased assurance of product safety and efficacy, risk management and implementation of corrective actions to address or avert enforcement actions. Mr. Dzierozynski has worked in the pharmaceutical, medical device and biologics industries in technologies such as: Animal Care, Bulk Chemical Manufacturing, Aseptic Processing, Blood and Blood Component Processing, Combination Products, Drug Sample Accountability, Infant Formula Manufacturing, Medical Device Software, Sterile Medical Devices and Vaccines. Also, as a member of a corporate 21 CFR Part 11 Executive Committee, Mr. Dzierozynski provided guidance to the Electronic Records, Electronic Signature compliance effort and associated computer system validation efforts based on industry benchmarks for clinical, sales force automation and late phase software applications.
Mr. Dzierozynski was Vice President of Validation Services at Quintiles Consulting and worked in industry at Baxter Healthcare Corporation in varying engineering and management positions. He received a B.S. in Mechanical Engineering from the Illinois Institute of Technology in Chicago, Illinois. He is a member of the Parenteral Drug Association, International Society for Pharmaceutical Engineering and the American Society of Mechanical Engineers, and is a frequent presenter at pharmaceutical and medical device industry conferences.
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