| |
|
|
|
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
13-15 April 2015
Who Should Attend
This course is intended for professionals in:
• Process Engineering
• Production
• Quality Assurance
• Validation
• Technical and Management positions
You should have some familiarity and experience with the basic subject as it applies to research and manufacturing of pharmaceuticals, personal care products, biologics, medical devices,nutritional materials or fine chemicals. Description
This course will provide a solid overview of the principles and practices of residue removal and residue measurement on product contact surfaces. It will address the latest issues, industry practices and risk-based compliance strategies regarding choice of cleaning techniques, cleaning agents, analytical methods, residue challenges, grouping strategies, and validation protocols. Examples and case histories will be presented. Recent regulatory expectations and guidance from US and Europe will be discussed in depth.
For participants experienced on this subject, this practical course will help to better audit, evaluate and develop their own or third party cleaning programs to balance production objectives against QA/validation objectives. The idea is to first achieve an effective, reliable cleaning process defined parametrically, then generate sufficient data without going overboard on the number of samples, the number of analytical tests and the number of qualification studies that have become an excessive burden to many firms.
Participants are encouraged to bring a cleaning problem to the course for evaluation by participant teams or for inclusion in “Participant Problem Clinic” on the second day.
|
|
|
|
|
|
|
|
Organized by:
|
|
CfPA-The Center for Professional Advancement |
|
|
Invited Speakers:
|
|
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.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
n/a
|
|
|
|
|
|
|
|
Registration:
|
|
Please click here for registration information.
|
|
|
E-mail:
|
|
sberg@cfpa.com
|
|
|
|
|
|
|
|
|