Global BioPharmaceutical Resources Inc.

Forms

Registration Form

Brochure

Brochure

Hotel Information

San Francisco Marriott Marquis
55 4th street
San Francisco, CA 94103
Ph: 415-896-1600
Code: GBPR, Inc./Global Biopharmaceutical Resources

The event is SOLD OUT.

Registration Fee

$1050.00

Overview

This practical pharmaceutical cleaning validation course will provide the principles of process cleaning as a critical component of validation, contamination control, and cGMP compliance. During this live and interactive training course, the latest industry practices and comprehensive compliance strategies regarding choices of cleaning agents, analytic methods, grouping plans and validation studies will be discussed. Integration into any cleaning strategies should include choices based on risk analysis and compliance requirements. A review of how to set levels for residues such as MAC (Maximum Allowable Carryover) and other risk measurements of residues will be reviewed in terms of how clean is clean enough. Related topics of validation "best practices" and automation systems are presented as they pertain to critical process cleaning.
A hands-on workshop will use actual case studies as an opportunity for participants to apply to real life the information presented as well as the methodology and techniques learned by designing a cleaning validation study.

Who Should Attend

This course can be of interest to professional in a variety of functions relating to cGMP compliance, cleaning, and validation. QA/QC personnel including managers, supervisors, and technicians, cleaning personnel, validation managers, supervisors, and technicians, manufacturing personnel, engineering and maintenance, and research and clinical manufacturing personnel involved in equipment cleaning and cleaning validation.

Industries

Pharmaceuticals, Biotechnology, Biologicals, Cosmetics, Medical Devices, and Vaccines

Learning Objectives

Upon completion of this course, you will be able to:
• Plan, organize and conduct cleaning validation studies for cGMP compliance
• Learn the principles of chemical and microbiological residue removal
• Analyze and interpret data from cleaning validation studies
• Write cleaning validation protocols and manage and follow-up cleaning studies
• Develop a strategies to establish cleaning residue limits
• Know the key FDA regulatory focus areas in cleaning validation

Presenter

Frank S. Kohn, Ph.D.
FSK Associates, Inc.

About Presenter

Frank S. Kohn is president of FSK Associates, Inc. , an international Consulting company providing services to the pharmaceutical, biotechnology, and vaccine industry. Frank worked for Wyeth, where he was Director of Manufacturing at the Sanford, N.C. location. Dr. Kohn has more than thirty years of industry experience working in various technical, quality, and management positions for Schering Plough Corp., Armour Pharmaceutical, Sanofi, and Wyeth Vaccines. He holds graduate degrees in environmental microbiology and operations management. In additional, he has taken additional courses in cGMP regulation and has had several years of direct contact with FDA and various Boards of Health. Frank is a specialist Microbiologist by the National Registry of Microbiology (American Academy of Microbiology) and registered as a specialist Microbiologist by the American Society of Clinical Pathology Board of Registry and the Canadian College of Microbiology. He was on the Publication/Internet Committee of ISPE and chair of ISPE discussion forum on technology transfer. Also, he is chair for the Vaccine AInterest Group for PDA and Section Head for the Biopharm Development Interest Group for PDA.
Dr. Kohn is the co-author of the book, "Isolation Technology in Pharmaceuticals: Selection, Validation and Use" and presented numerous technical Papers, seminars and lectures. Frank has taught courses for the past 15 years via The Center for Professional Advancement and PDA in US and Europe. He provides consulting services in microbial Control, technology transfer, new technology, technical marketing support, GMP training, audits, cleaning validation, regulatory submissions and master validation planning.