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CfPA-The Center for Professional Advancement, Orlando, FL
February 1-3, 2016
Who Should Attend?
This course is intended for Technical and Management professionals in:
• Research and Development
• Process Engineering
• Manufacturing
• Quality Assurance
• Procurement/Supply Chain
• Validation
You should have some familiarity and experience with cGMPs and validation as it applies to research and manufacturing of pharmaceuticals, personal care products, biologics, medical devices, nutritional materials or fine chemicals.
RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion. Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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| Steven A. Weitzel; VP Technical Operations, CANI, Inc. Critical Process Cleaning |
Mr. Steven A. Weitzel is Vice President-Technical Operations of CANI, Inc. Critical Process Cleaning. He is a recognized subject matter expert on process development and validation of cleaning and contamination control for sterile and non-sterile dosage forms, APIs, combination products, cosmetic and consumer products and emerging natural medicines and nutritionals., He has conducted technical training or consulted for the world’s leading pharmaceutical, biotech, cosmetic and medical device companies. He primarily works in North America and Europe, but his work has extended to the Middle East, India and Southeast Asia within companies of all size and structure.
He earned a B.S. in chemical engineering from the University of Missouri, and a Masters in Business Administration from Washington University in St. Louis. He is a pharmaceutical process engineer with over 25 years technical experience in FDA regulated industry. Mr. Weitzel held technical and management positions at Novaflux Technologies, Bristol-Myers Squibb, Calgon-Vestal/Merck, Mallinckrodt, and Dow Chemical with direct experience in engineering, manufacturing and validation of medical devices and in-vitro diagnostics, bulk pharmaceutical compounds, oral drugs and nutritionals, terminally sterilized and aseptic parenterals. Mr. Weitzel has been involved in hundreds of facilities, projects and applications related to critical systems, contamination control, cleaning or process validation.
Current responsibilities include external technical support and technical marketing, as well as managing all internal technical operations -manufacturing, validation and quality systems for CANI process cleaning agents.
Mr. Weitzel is a frequent industry speaker and is consulted regarding process validation and validation master plans; risk evaluation methods and tools; risk-based microbial control and environmental monitoring; aseptic manufacturing; critical cleaning and cleaning validation; continuous process improvement and change control. He has been involved in several professional organizations, serving on technical, training and policy committees. He is a member of PDA and ISPE.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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This practical course will help participants to better audit, evaluate and update their own or third party cleaning programs to balance production objectives against QA/validation objectives in order to achieve continuous process improvement. The idea is to first achieve an effective, reliable cleaning process defined parametrically, then generate sufficient qualification data without going overboard on the number of samples, analytical tests and qualification studies.
Participants are encouraged to bring a cleaning or validation problem scenario to the course for evaluation by participant teams or for inclusion in “Participant Problem Clinic” on the second day.