GMP and QSR Workshops

GMP/QSR Executive Briefing
A workshop customized specifically for your senior management team. Primary focus is on management’s responsibility for compliance and FDA’s expectations of senior management.

GMP/QSR 101 – The Basics
An introductory GMP workshop introducing the basic principles of GMP. Includes background on FDA and how they operate. Also delves into the evolution of food and drug law.

Annual GMP/QSR Training Updates
This course meets the Code of Federal Regulations GMP requirement of “ongoing GMP training on a regular basis.” This is always customized to meet your specific needs

GMP/QSR Advanced Topics
Focuses on latest developments in industry and FDA. This is always customized to meet your specific needs.

GMP and Problem Prevention
A hands-on workshop aimed at helping people learn how to implement simple tools and techniques to collect process data and work to optimize your processes. Ideal for people in manufacturing. FDA has recently been focusing on PAT, Process Analytical Technology, as a means for managing and improving processes to prevent problems from occurring. This workshop teaches PAT in a simple straightforward manner. This workshop also meets the requirements of CAPA – Corrective and Preventive Action.

Managing for GMP
Designed for anyone in a leadership position (managers, supervisors, leads, …). Fundamental leadership and management skills are covered within the framework of GMP responsibility. This is best delivered over a four to six month time period, with groups meeting for one day every 4 to 6 weeks. Application assignments ensure that implementation takes place.

Auditing for GMP
Designed for those who conduct internal and external audits. Useful for those needing an advanced refresher in the basic GMP principles.

GMP Train the Trainer
Designed for those who are called upon to conduct GMP training. This is a very hands-on workshop where participants develop and deliver a specific GMP lesson plan.

GMP Enhancement Master Plan
Designed for those whose responsibility includes overall GMP training for a facility. Especially helpful when searching for ideas on presenting GMP in a fresh manner.

CFR Part 11 Electronic Record keeping and Electronic Signatures
Learn the latest on this rapidly evolving topic.

The Evolution of Food and Drug Law from the 19th Century to the 21st Century
This unique presentation is conducted by David Markovitz as Teddy Roosevelt.

Click here to learn more about David’s presentation as Teddy Roosevelt.

Systems and Process Optimization workshops

Innovation and Leading Edge Thinking workshops