This webinar will provide valuable assistance to all regulated companies that need to validate their systems
This is the first in a series of sessions for process validation using Six Sigma methods. The series will deal with Operational Qualification (OQ), Performance Qualification (PQ), and maintaining a state of validation using statistical methods associated with Six Sigma. This first session is an overview of the validation process showing where and how various Six Sigma methods apply. Subsequent sessions will teach those Six Sigma methods and how they are applied to process validation.
Areas Covered in the seminar:
- The steps required for OQ and which Six Sigma methods apply to each step
- The steps required for PQ and which Six Sigma methods apply to each step
- How to apply Six Sigma methods to maintain a state of validation by understanding and reducing process variability
- How to apply Six Sigma methods to maintain the process in a continued state of control through disciplined SPC and SQC methods
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- End-users responsible for processes requiring validation
- QA managers and personnel
- Validation specialists
- Consultants
- Quality system auditors
- Process Engineers
Instructor Profile
Lawrence S. Mucha, is a management professional with over thirty years experience in the beverage and packaging industry. He is Vice President and co-owner of The ZDM Group LLC. Prior to joining ZDM Group in 2004 as Manager Future Technologies Development Larry spent 25 years with The Coca-Cola Company. During his career with Coke he was responsible for several top priority, highly visible packaging projects as well as Director of Future Technologies, Director of Quantum Leap, Director of Plastics Packaging Development, and Director of Technical Packaging Department, Northwest European Division, London. Larry began his career as a packaging engineer.
He has been a practitioner of statistics, SPC, and DOE for over 28 years, most recently with ZDM as both a practitioner and instructor of Six Sigma methodologies. Larry holds three package patents and has two pending. He is certified by the Project Management Institute as a Project Management Professional, a Certified Packaging Professional by the Institute of Packaging Professionals and a Six Sigma Master Black Belt. He is a member of American Chemical Society, Innovation Network, World Future Society, Project Management Institute, The American Society of Quality, The International Society of Beverage Technologists, and Institute of Packaging Professionals. He is a frequent speaker at conferences and author of various articles for professional publications.
