Excipient Risk Analysis and Auditing

About this course

This course will review recent legislation enacted by key regulatory bodies including EMA, FDA, CFDA, ANVISA to ensure excipients are produced and supplied according to Good Manufacturing Practice. The impact on excipient manufacturers, brokers and distributors will be reviewed along with the expectations of drug product license holders. This course will explain expectations for excipient risk analysis and how to adapt your company’s Vendor Management Program accordingly. The pharmaceutical industry often accounts for only a small proportion of an excipient manufacturer’s volume and often auditors need to work around time constraints. This course will cover good auditing techniques and strategies to overcome these constraints while meeting your company’s objectives.

Course outline

Recent changes in legislation impacting excipient manufacture and supply:

• European Falsified Medicines Directive and provision for verifying excipients are produced according to “appropriate GMP”
• GMPs for excipients recently issued in China and Brazil Effective Application of Risk Analysis:
• European draft guidance on Excipient Risk Assessments
• Establishing a risk-based Vendor Management Program Effective Audit Programs for Excipients:
• Strategies for conducting highly effective audits of excipient manufacturers
• Auditing techniques for abbreviated audits

Venue

NSF Health Sciences Boston Office, Boston, MA, USA

These courses will take place in the

The Washington Marriott
1221 22nd St NW
Phone: (202) 872-1500
Washington, District of Columbia 20037
United States

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  Mrs Luba Skibo
  Executive Director
  M.S. Agricultural Chemistry, M.S. Analytical Chemistry

  • [email protected]
  • + 1 857 277 0060
• 

  Mrs Janeen Skutnik
  Vice President
  BSc

  • [email protected]
  • + 1 857 277 0060

What you've said

What Delegates Have Said About Our Courses:

“The best course in years.”

Lene Hansen, Novo Nordisk, Denmark

“The most useful course I’ve ever been on. I wish my colleagues had been here as well.”

Flemming Mørch Hansen, Bavarian Nordic, Denmark

“I got much more than expected! Thanks.”

Heidi Meinertz Jensen, NNE Pharmaplan, Denmark

“Very good course, I’m highly motivated to go back and look at human error in a new way!”

Michael Nordahl, Novo Nordisk, Denmark

“Relevant, well researched, well presented content.”

Shirley Mutch, Genzyme, Ireland

“Tutors excellent and easy to understand. The notes are excellent and, again, easy to follow.”

Maureen Forster, Catalent, UK