Risk-Based Qualification of Sterile Drug Product Manufacturing Systems

Bethesda, MD
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Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.

This course is designed to teach students the techniques for effective qualification and validation of sterile drug product manufacturing systems. It will use a combination of lecture and hands-on application at the PDA Training and Research Institute and will make extensive use of the Aseptic Processing Suite. Instructors will walk students through the planning, protocol development, execution, and troubleshooting of the qualification of various drug product manufacturing systems, including critical utilities, formulation/compounding, component parts sterilization, filling, and packaging. Lectures and case studies will provide students the regulatory expectations, industry trends, and best practices for qualification and validation of sterile drug product manufacturing systems utilizing modern risk- and science-based decision making approaches.

If you are involved with the planning, documentation, execution, or review of sterile drug product manufacturing system qualification and validation for capital projects or on-going facility operation and remediation, this hands-on course will provide essential knowledge and training in the approaches needed to successfully perform those functions.

Who Should Attend

Individuals involved directly with the planning, protocol development, field execution, or quality management Commissioning, Qualification, and/or Validation of manufacturing equipment, facilities, and systems utilized in the manufacture of sterile pharmaceutical and biopharmaceutical products – including:

  • Validation Engineers
  • Validation Specialists
  • Validation Managers
  • Project Managers
  • Quality Assurance Reviewers
  • Validation and System Subject Matter Experts
Event Location
PDA Training and Research Institute
4350 East West Highway, Bethesda, MD Get Directions

Contact

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More information coming soon.

Day 1

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

  • Identify the aspects of sterile drug product manufacturing which affect product quality and require qualification and validation
  • Discuss the types of and reason for approaches to sterile drug product manufacturing qualification and validation
  • Describe the appropriate methodology for making risk- and science-based decisions related to the planning and execution of qualification and validation of sterile drug product manufacturing systems
  • Explain and demonstrate the best practices for sterile drug product manufacturing system qualification and validation

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD ,
Walter Henkels, Concordia ValSource

Mr. Henkels has over 19 years of ongoing experience in the startup, qualification and auditing of aseptic manufacturing facilities and processes. Having been in the role of both owner and consultant, Walter has been immersed in the development of leading edge technologies and is helping clients meet the current and ever dynamic industry and regulatory expectations.

As a microbiologist, Walter has thorough knowledge and teaches, on the client level, the importance of educating aseptic operations personnel on aseptic manipulation, process control and environmental monitoring.

Through his years working as both a direct employee and a consultant, Walter brings his exceptional and practical knowledge of regulatory expectations in aseptic manufacturing and facilities. Walter has expertise in ISO classification for environmental containment, aseptic processing and Aseptic Process Validations (APV), Pre-Approval Inspection (PAI), Global Regulatory guidelines.

Walter holds his BS in Biology (emphasis on microbiology) from Bethany College, BA in Psychology from Bethany College, and Master's in Quality Assurance/Regulatory Affairs from Temple University.

Marsha Hardiman, Concordia ValSource

Marsha Stabler Hardiman has over 20 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha has a Bachelors in Biology from Western New England University in Springfield, MA. Marsha is an expert in industrial Microbiology test methods from environmental monitoring and utility system microbial testing to intermediate product testing through final product sterility testing. Marsha also served as a Notified Body regulatory inspector for CE certification of medical devices and has extensive knowledge in quality systems. Over her career, Marsha has either executed, performed, reviewed and/or approved hundreds of equipment validations for manufacturing and/or laboratory equipment.

Marsha is active in industry and currently serves on the Parenteral Drug Association (PDA) Science Advisory Board; is leading a PDA Task Force on Microbial Data Deviations; serves on the PDA Microbiology Meeting Planning Committee and has been the co-chair of the PDA Annual Meeting. Marsha also serves as a voting member on the ISO 14644 Liquid Chemical Sterilization Working Group.

Marsha is a Senior Consultant for Concordia Valsource and in this role helps companies implement quality risk management into their quality management systems and validation programs.