GMP and cGMP In-Plant Training
Training conducted for your people at your facility. Let our experts be your experts!
Our courses and workshops are designed specifically for the drug, medical device, cosmetics, dietary supplement, and food industries. All of our training can be customized to meet your specific needs.
Our courses and workshops are conducted by leading experts in their respective field. We have assembled a team of highly qualified experts to ensure that you receive the highest quality instruction. All of our instructors have worked in industry and have the experience of being on the receiving end of an FDA inspection. They have all successfully implemented corrective and preventive actions. If you’re not completely satisfied, our money back guarantee removes the risk.
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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.
GMP Systems and Process Optimization Workshops
System and Process Optimization
Learn how to identify work as a system comprised of interacting processes. Identify the types of specific variation and how to minimize the effects from variation. Learn specific tools aimed at optimizing your systems over time.
Making the Invisible Visible
Understanding and Applying Statistical Process Control (SPC)
Learn how to develop and apply Control Charts in managing your processes to prevent problems before they occur. This is best delivered in short segments over a twelve to fifteen week time frame with people working on applications projects during the time between sessions.
Optimizing Teams for Results
Designed to help people learn specific skills, tools, and techniques for working together on specific projects, or just on the job.
Deming’s Red Bead Experiment
We recreate Dr. W. Edwards Deming’s Based world famous Red Bead Experiment. This interactive group exercise demonstrates how quality is dependent on designing robust systems, and that good people working in a poorly designed system will yield poor results. Fun and provocative.
Innovation and Leading Edge Thinking Workshops
Leading Change and Innovation
Designed for leaders who are tasked with helping people adapt to change in their organization and/or industry. How to lead people in implementing positive change and innovation within the framework of GMP and Change Control.
The Secrets of Powerful Presentations
Designed for anyone who is required to present at meetings. Increase your personal effectiveness by being able to develop and deliver powerful presentations.
Six Thinking Hats®: High Performance Thinking
Based upon the ground breaking work of Dr. Edward de Bono, this world class workshop helps people who are working together learn the power of thinking together to create significant results. This is one of the best approaches in enhancing communication and decreasing misunderstandings within work groups and teams.
Innovation Boot Camp
A hands-on workout designed to pump up your Innovation Instinct™.
Lateral Thinking™: A Tool Kit for Productive Idea Generation
Designed for individuals and teams that need fresh new thinking. Increase your practical idea output. Learn how-to systematically challenge the status-quo to uncover new ways that would otherwise remain hidden.
Focus on Facilitation™: The Complete Course for Organizing,
Managing and Leading Group Thinking
Designed for team leaders, project leaders, six sigma green and black belt leaders, and meeting facilitators who need to be able to structure thinking frameworks to lead group discussions that end up with workable solutions that are supported and actionable.
