Development and Implementation of Qualification and Validation Protocols - A Risk and Science Based Approach

Bethesda, MD
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Regulatory compliance and business success require establishing and demonstrating confidence in the control of processes related to product quality and patient safety. Product quality must be predictable, processes must be effective, and the systems which support those processes must be reliable.

The understanding of process related hazards and relative risks are essential for efficient and effective qualification and validation of manufacturing systems and processes. The objective of this course is to provide a basis by which the participant can develop and implement risk and science based approaches, as well as integrate and maintain programs, to qualify and validate biopharmaceutical and pharmaceutical systems and processes.

The course will include background and instructional information on modern risk and science based qualification and validation methods, group participation, and workshop exercises in protocol development, risk assessment, and results analysis.

Who Should Attend

Managers and technical support staff responsible for the design, planning, qualification, validation, operation, testing and investigation of biopharmaceutical and pharmaceutical processes will benefit from this course.

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Apply risk management in making informed scientific decisions related to qualification and validation
  • Interpret the regulatory basis and expectation for risk based qualification and validation programs
  • Identify critical process steps and qualification/validation approaches
  • Prioritize and plan effective qualification and validation programs
  • Select efficient qualification and validation approaches
  • Choose useful test functions and acceptance criteria
  • Develop qualification and validation plans, procedures, and protocols
  • Assess failures and conduct investigations
  • Create systems for controlling changes to and maintaining qualification and validation programs
Agenda is subject to change.

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD , United States

Hal Baseman, Chief Operating Officer and Principal, ValSource LLC

Hal Baseman is Chief Operating Officer and a Principal at ValSource LLC, a 250 employee validation consulting and service firm. He has over 38 years of experience in pharmaceutical operations, validation and regulatory compliance. Hal has held positions in executive management and technical operations at several drug manufacturing and consulting firms. Hal is the immediate past chair of the PDA Board of Directors, former Co-Chair of the PDA Science Advisory Board, former Co-Leader of the PDA Validation Interest Group, Co-Chair of the PDA Aseptic Process Simulation Technical Report #22 Task Force on Aseptic Process Simulation, Co-Chair of the PDA Risk Management Technical Report #44 on Quality Risk Management of Aseptic Processes. Co-Leader of the PDA Aseptic Processing Points to Consider. Hal is a long time member of the PDA and its Training Research Institute faculty. He is a frequent instructor and presenter on subjects related to Quality Risk Management, Validation, and Aseptic Processing. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.