Calibration for FDA Regulated Industries
Provides the training that technicians who are calibrating
instrumentation for Pharmaceutical, Medical Device, Food, Veterinary
Drug, and Biologics companies need to comply with US-FDA regulations.
| Who Should Participate: |
Anyone who calibrates, or checks the calibration of equipment or
instrumentation in FDA regulated industries; anyone who supervises this
activity. |
Class Length:
|
Normally 1.5 hours
|
Course Prerequisites:
|
None
|
Course Objectives:
|
At the conclusion of the class a participant will have an understanding of the following:
|
- Who is the
FDA and what power do they have?
- Current Good Manufacturing Practices as they apply to calibration
- Why cGMPs are necessary
- Why
finished product testing is insufficient to assure quality
- Why FDA regulated facilities are different
- The importance of Standard Operational Procedures
- How to fill in records and what to do if there is an error
- The importance of the individual employee's role in assuring
product quality
- What are Out of Tolerance results and what do you do when they occur?
- Cleanliness, Clothing, and Security in GMP environments
- "If you didn't document it, you didn't do it"