6-Hour Virtual Seminar on Auditing Analytical Laboratories for FDA Compliance
Training
Online
*Indicative price
Original amount in USD:
$ 445
Description
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Type
Training
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Level
Advanced
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Methodology
Online
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Class hours
6h
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Duration
1 Day
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Virtual classes
Yes
It is necessary for a company to know if an analytical laboratory is capable of operating in compliance with GMP or other regulations.
Reviews
Subjects
- Compliance
- Auditing
- IT Auditing
- Education
- Training
- Financial
- Medical
- Technology
- Best Practice
- Employees
Teachers and trainers (1)
Event Manager
Traning Provider
Course programme
There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.
The second phase considers what must be considered during the audit itself. Audits conducted by inexperienced or ignorant auditors are often worthless, wasting the time and money of both the auditors and the laboratory being audited. Auditors who are familiar with laboratory operations are needed as it is easy to be fooled into thinking that a non-compliant laboratory is operating normally. Different types of laboratories will require different auditor/specialists. We will discuss the pitfalls that auditors can fall into, and what questions laboratories may expect to encounter.
Additional information
6-Hour Virtual Seminar on Auditing Analytical Laboratories for FDA Compliance
*Indicative price
Original amount in USD:
$ 445