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Introduction to GMP System-Based Audits

 
  August 06, 2015  
     
 
CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
September 24, 2015 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This introductory online presentation will benefit professionals in the pharmaceutical and related industries such as: medical device, dietary supplements, cosmetics, biotechnology, biologics, who are responsible for GMP compliance issues. The course will be of great interest to newly assigned auditors or those who expect to be involved in auditing in the near future. It can also be used as a refresher course for more experienced auditors.

The material presented will be very beneficial to professionals in the following areas:
  • Management responsible for the audit function 
  • Quality Assurance 
  • Quality Control
  • Regulatory 
  • Vendors and suppliers to these industries 
  • Laboratory
  • Production 
  • Packaging 
  • Documentation writers and managers

Course Description
This course will be available On Demand: September 25, 2015

Auditing is a major management tool to ensure compliance with regulations and standards. The need for GMP system-based audits is a worldwide requirement at all stages, starting with active pharmaceutical ingredient (API) , bulk pharmaceuticals, finished pharmaceuticals, medical device, biologics etc. This 90-minute accredited training course provides an introduction to the major regulations and standards requiring companies to have in place an audit function. It details the beginning stages for setting up a system-based audit program and concludes with a few examples of check points during drug and device system-based audits.

Can't Make this LIVE Webinar? 
Simply select the On Demand option when registering and we will send you the link to view the recorded version.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Renée B. Galkin; Quality Management Consultant

Renée B. Galkin is a quality management consultant with over twenty years experience in the pharmaceutical and medical device industries. Her areas of expertise include quality audits, quality programs, FDA regulatory compliance, GMP training, documentation systems management, strategic planning and organizational development.

Prior to starting her own consulting business, Ms. Galkin held managerial positions with two major companies – Wyeth Pharmaceuticals, Inc. (now Pfizer) and Science Management Corporation (a multinational consulting firm). Throughout her career she had both domestic and international assignments.

Ms. Galkin holds an MBA in Business Management from New York University, an MA in Education from Brown University and a Bachelor of Science in Biology from Northeastern University. She is a member of the American Society for Quality, the Parenteral Drug Association and the International Society for Pharmaceutical Engineering (ISPE). As a consultant, Ms. Galkin provides training, auditing and compliance advisory services to companies worldwide. She also directs several technical courses offered by The Center for Professional Advancement.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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