Training & Events

A working knowledge of Good Manufacturing Practices (GMP) is a regulatory requirement, and supports the manufacturing and sale of products that are safe, effective for patients and consumers. Compliance weaknesses can impact patient health, consumer confidence, regulatory licensing, and create a business liability. As a result, the implementation of good systems that meet the regulatory requirements is essential.

Day 1 :

A thorough overview of the primary GMP topics for professionals who have limited experience in GMP or who would like a refresher. The topics below will be covered in the class, including current regulatory expectations in meeting the expectations. Case studies and industry specific scenarios will be incorporated throughout to provide participants with a tangible understanding of the intent behind the legal requirements.

• Definitions
• Licensing and Licensable activities
• Health Product Classification and impact to regulatory focus
• Quality – how is it attained?
• Documentation and Data Integrity
• Premises
• Equipment
• Sanitation
• Quality Control
• Sampling and Testing
• Packaging and Label Control
• Basics of Validation – Analytical, Process, Method, Cleaning, Computer
• Intro to Quality Systems
• Record requirements
• Stability program

*Course attendees are encouraged to email examples of GMP concerns or challenges for group discussion and instructor feedback prior to class nicole.schepp@compliantapproach.com

All participants will receive package of course materials to keep, along with a certificate of completion. This course meets the regulatory requirements of annual GMP training.

Intereested in taking the Intermediate class - click here for more info.  Save when you sign up for both classes.

INSTRUCTOR INFORMATION

Nicole Schepp, a GMP expert at Compliant Approach Inc., has worked with Health Canada for over 6 years, and in the pharmaceutical industry for over 12.

Her experience working in R&D, Method Development, Veterinary drugs, Biologics, NHPs, and as a consultant makes Schepp a valuable GMP resource and educator. She brings valuable experience and energy to the classroom, providing interesting, value-added, and relevant material to participants.

Schepp currently holds a MSc in Pharmacy from the University of Manitoba, and a BS from the University of Winnipeg.