Conference Program

Monday, September 22, 2008

101 Risk-Based Qualification Approach to Streamlining Validation

Instructor: Tom Dzierozynski, Avarent; Michael McAndrew, Director, Quality Baxter Healthcare Corporation; Ian Fleming, Senior Partner, Avarent LLC Part 1 - Risk-Based Qualification Approach to Streamlining Process Validation Basics of Risk Management Understanding fundamental concepts and tools of risk management to be utilized in streamlining process validation FDA’s current focus on risk management in Quality Systems Examining current industry challenges and overall benefits of risk management Risk Management and Validation Identifying elements of risk management that can apply to the validation lifecycle Building and executing comprehensive process validation strategies based on risk management outputs Identifying boundaries, critical points, statistical methods and validation approaches Structuring design control activities/Good Engineering Practices and commissioning to support risk-based process validation Managing Risk Beyond Validation Execution Defining attributes that drive revalidation and maintenance of a validated state of control Evaluating the effectiveness of risk management to facilitate changes, promote continuous improvement and create efficiency Review of common pitfalls and mistakes Part 2 - Achieving Harmonized Compliance in Production and Process Controls Regulatory Harmonization Understanding convergence in regulatory practices to ensure the safety, effectiveness, and quality Defining challenges in promoting global technological innovation Recognizing how quality initiatives are integrated and aligned with organizational mission and values Definition and Alignment of P&PC Building defendable processes - devices meeting specifications, verifying/validating processes, and monitoring and controlling the processes Verifying control and monitoring activities Implementing process changes utilizing risk management Understanding the P&PC linkages (e.g. Purchasing Controls, Acceptance Activities, Nonconforming Product Control, CAPA, Personnel, etc.) Addressing process deviations Success Criteria Designing processes for decreased risk and increased business performance Control, adaptability, efficiency & scalability (capacity for growth) Understand business drivers and organizational priorities “Future-Proofing” the process

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ABOUT THE INSTRUCTORS

Tom 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.

Michael McAndrew, Director, Quality Baxter Healthcare Corporation
To be updated shortly

Ian Fleming, Senior Partner, Avarent LLC
To be updated shortly

 

 

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