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Writing SOPs for cGMP Compliance

 
  July 06, 2017  
     
 
CfPA-The Center for Professional Advancement, Las Vegas, NV
October 16-17, 2017


Who Should Attend?
This intensive course is designed for professionals involved with manufacturing in the pharmaceutical and dietary supplements industries. It has been most beneficial to:

  • Those who are responsible for, or may be involved in, writing or revising “Standard Operating Procedures” (SOPs)
  • Suppliers of drug and supplement components including raw materials, containers, closures, and other packaging materials
A working knowledge of Current Good Manufacturing Practice (cGMP) regulations is recommended.

Please note: Although the focus is on cGMP requirements for drug manufacturers, anyone in the life science industries who needs to write effective procedures will benefit from the course. 

 

Course Description
This two-day intensive course is designed to detail step-by-step guidelines for writing “Standard Operating Procedures” and how to make them more effective for your operation.

Although the FDA’s cGMP regulations state requirements for “Standard Operating Procedures,” this is the one area most likely to be cited by the FDA upon an inspection. Upon completion of this training, you will have a better understanding of the FDA's expectations. Methods used for compiling information, assignment of responsibility for departmental procedures, control of procedures and documentation, and instruction on technical writing will also be discussed.

Open workshops will offer solutions for your particular problems, and will demonstrate the process of writing procedures for so called “gray areas.” Workshops are designed to allow you to construct a written procedure for a hypothetical manufacturing situation.

Emphasis will be placed on simplifying your procedures and ensuring they are integrated to create a complete “Process Control System” as required by the FDA.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Gary Callahan; CEO/President, Consulting Services, Inc.

Gary Callahan, has over forty years of hands-on and management experience in the pharmaceutical manufacturing industry. Throughout his career, he has implemented many GMP and SOP programs in several different companies to meet compliance standards set by the FDA. Mr. Callahan has managed key projects resulting in securing four state issued drug licenses for four different drug manufacturing companies in the State of California.

Mr. Callahan holds a Bachelor of Science degree in Business Administration and a Masters degree in Business Management from Almeda College and University, as well as a Bachelor of Science degree in Pharmaceutical Sciences from the University of California at Berkeley. In addition, Mr. Callahan has worked on the research and development of new drug products at the University of Iowa, School of Pharmaceuticals. He has also been licensed by the California State Board of Pharmacy as a Manufacturer of Dangerous Drugs. 
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
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