Course offering number:0812-702
Course ID:
2244
Introduction To Pharmaceutical cGMP
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course will be beneficial to professionals in the pharmaceutical industry especially:
• Employees who need basic cGMP training
• New Hires or Transfers from non cGMP areas
• Employees who have demonstrated a need for retraining
Description
This 90-minute accredited training course introduces the employee to the cGMP environment. The attendee will gain
understanding of the FDA, the Code of Federal Regulations, the reason for the unique laws governing pharmaceutical
manufacturing and its role in the pharmaceutical arena.
Module 1:
• The need for the FDA and the
cGMP's in our industry
• FDA enforcement
• The “Act”
• Introduction to 21 CFR, Parts 210 and
211
• Case study from the early cGMP
history
Module 2:
• CFR 21, Part 210 Definitions
• The index to Part 211
• A brief overview of each section of
211 with examples of how they relate to job performance
• A case study of how a company uses cGMP's to gain instructions for
improving their performance
Module 3:
• The 7 key areas that are necessary for
compliance to the
cGMPs
– Follow good documentation
– Keep it clean
– Follow procedures
– Don't make any unauthorized changes to anything
– Avoid mix-ups
– When in doubt, ask
– The data, record and logs we create doing our job are
critical; The most critical is the batch record
Question and Answer Session