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Auditing Analytical Laboratories for FDA Compliance (ntz) A
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Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Who will benefit:
The following specific types of workers will benefit from this webinar:
- External and Internal Auditors
- Supervisors and Analysts in Quality Control Laboratories and Quality Assurance groups
- Supervisors and Analysts in Contract Testing Laboratories
- Personnel Responsible for Selecting Contract Testing Laboratories
- Consultants
Day 1 Schedule
Lecture 1:
GMP Regulations that Apply to Analytical Laboratories
Lecture 2:
Reviewing Documentation
Lecture 3:
Advance Preparation for the Audit
Lecture 4:
Auditing Styles and Structures
Day 2 Schedule
Lecture 1:
Equipment and Laboratory Instrument Qualification
Lecture 2:
What to look for while doing a Walk-Through
Lecture 3:
Other Regulations and Standards, including ISO 17025
Lecture 4:
Following through on the Audit