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:
- Protect the product from contamination
- Prevent mixups — “confusion regarding identity or status” for labels, products, ingredients, etc.
- 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
- Document all activities including any procedure, any use of equipment, executing a lab method, a batch production record
- Strive for consistency and control
- Have management support an independent group that makes final decisions on documents, product release and quality issues
- 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