Leading the climb for Compliance:
GMPs for supervisors & quality unit members

What do mountain climbing and GMPs have in common?

Being a guide with technical and leadership skills is part of the answer!

Industry field:

Pharmaceutical and Biopharmaceutical industry. US and EU regulations.

Course goal:

Develop your knowledge and skills so you can better interpret and apply current Good Manufacturing Practice expectations in a variety of situations.

Who should attend:

Managers, supervisors, quality unit members, technical staff, and others who need a practical understanding of GMP.

Course description:

"Leading the climb for Compliance: GMPs for supervisors & quality unit members" is an advanced GMP training course aimed at those who have supervisory responsibilities in a GMP facility; it can also be used for personnel working in quality, compliance, training, and other staff positions. It can be adapted for finished pharma, sterile product, API, biopharma, or blood products.

The course uses a unique video produced by LearningPlus that builds an analogy of mountain climbing and being a guide: role modeling, systems thinking, coaching and feedback, and satisfaction in completing a challenging task are discussed.

Activities that involve collaboration and teamwork allow participants to apply their experience and newly gained knowledge to challenging situations as they develop answers using “GMP thinking”.

Participants use (and keep) a resource book containing a variety of regulatory reference documents, warning letters, and articles.

The course is annually updated to reflect revised FDA enforcement data, recent warning letters, and current industry/agency issues.

At the end of the course, a case study is used to illustrate the business, personal, and financial impact of not meeting GMPs. One of two case studies is used in the current course: Schering-Plough or Chiron.

Objectives:

• Define key words and concepts related to good manufacturing practice.

• Describe how the regulations, guidelines, best of industry practice, and other factors contribute to “Current GMP Expectations”.

• Discuss how quality system elements apply your role and responsibilities.

• Discuss how quality auditors and FDA investigators evaluate conformance to current GMP expectations.

• Identify the Seven GMP Essentials and discuss current GMP expectations that are relevant to your role and responsibilities.

• Given a GMP essential, evaluate current performance in your area and identify an opportunity for improvement

• Given an actual industry example, identify and discuss the regulatory, business, and personal consequences of not meeting current expectations.

• Describe considerations during an emergency or other unexpected event that will satisfy the Seven GMP Essentials and current GMP expectations.

• Describe the role of supervisors (at all levels of responsibility) in making drug products that meet current GMP expectations.

Course outline:

• Introduction.

• Terms of Compliance: A review of concepts and words important to the industry and the FDA.

• GMP Expectations: What they are and their sources.

• Quality Systems: GMPs as an example of a quality system.

• The Seven Essentials of GMP

• Essential 1: Protect the product from contamination

• Essential 2: Prevent mix-ups

• Essential 3: Know what you are doing before you do it

• Essential 4: Strive for consistency and control

• Essential 5: Document all activities

• Essential 6: Have an independent group make final decisions on documents, product release and quality issues

• Essential 7: Learn from mistakes, solve problems; monitor and continually improve

• Case Study: An examination of GMP compliance issues on an organization (e.g., Schering-Plough or Chiron)

• How I can apply this back in my job.

• Summary.

• Final assessment.

Course facts

Do you want our newsletter?

» Make sure to get the latest information

» Tip a colleague