Main Photo

 

Advanced GMP Training: The Seven Essentials for Compliance is an advanced two-day workshop led by an instructor with more than 30 years of pharmaceutical industry experience. Those who will benefit include employees with supervisory/management responsibilities and others working in quality, compliance, training and staff/technical positions.  The training covers GMP expectations in the U.S., Canada, Europe and the World Health Organization (WHO). 

An Interactive Seminar that Builds on Real-World Lessons
The workshop is designed to carefully reflect recent trends in FDA enforcement data and warning letters. Participants will get a different view of role modeling, systems thinking, coaching and feedback. Participants will use and keep a resource book containing a variety of regulatory reference documents, warning letters, and articles. In addition, a case study illustrates the business, personal and financial impact of not meeting GMPs. 

The 7 Essentials You Will Learn to Successfully Implement:

  1. Protect the product from contamination
  2. Prevent mixups — “confusion regarding identity or status” for labels, products, ingredients, etc.
  3. Know what, why, and how before you do it — how it’s supposed to be done (as defined by a procedure) and why it needs to be done this way every time
  4. Document all activities including any procedure, any use of equipment, executing a lab method, a batch production record
  5. Strive for consistency and control
  6. Have management support an independent group that makes final decisions on documents, product release and quality issues
  7. Learn from mistakes, solve problems; monitor and continually improve.

As the regulatory environment changes and manufacturing best practices evolve, so does GMP. Stay current by attending this two-day workshop, Advanced GMP Training: The Seven Essentials for Compliance. Register now to learn:

  • The personal, regulatory and business consequences of failing to meet GMP expectations in pharma and biopharma manufacturing
  • Key words and concepts related to good manufacturing practice
  • How regulations, guidelines and best practices contribute to current GMP expectations
  • The many ways quality system elements affect your role
  • How auditors and regulatory inspectors will evaluate you
  • What’s expected of personnel at all levels on the pharma and biopharma manufacturing chain

 


register