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Managing FDA Inspections

 
  February 10, 2016  
     
 
CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
March 22, 2016 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This 90-minute accredited training will benefit those professionals in the pharmaceutical, device, biotechnology, cosmetics and related industries who will, directly or indirectly, be involved in FDA inspections. Personnel in the following functions will find the presentation of value.

  • Executive Management 
  • Auditing 
  • Training
  • Quality Assurance 
  • Regulatory 
  • Engineering
  • Quality Control 
  • Manufacturing 
  • Procurement
  • Documentation Management 
  • Laboratory 
  • Suppliers to industry

Course Description
This 90-minute webinar presents a brief overview of the Agency role and authority and the types of inspections performed by FDA investigators. It also outlines basic strategic steps to be taken by companies in order to successfully manage FDA inspections. It concludes with details regarding FDA enforcement tools like Form 483 and Warning Letters.
 
 
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: jmorbit@cfpa.com
 
   
 
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