Description
Overview:
What controls should laboratories implement in an FDA regulated environment? This training course provides a thorough review of GMP/GLP requirements and current industry practice for labs which support clinical trials as well as those who provide quality control testing for commercial products. The training includes information on science based management practices, such as:
- Calibration programs
- Analytical method validation
- Equipment qualification
- Control of standards and reagents
In addition, the course emphasizes laboratory quality system elements, as follows:
- SOPs
- Documentation practices,
- Outsourcing,
- Training programs, and
- Change control
The speaker will also cover advanced topics which include out of specification (OOS) investigations, stability testing, and computer systems validation as it pertains to the laboratory.
As is apparent from the multitude of GMP warning letters related to laboratory compliance, laboratory controls is an area the FDA considers vital to drug product safety, quality, and efficacy. The laboratory plays a crucial role in the development and manufacture of drug products from the approval of submission documents to the release of the final product. Whether you work in paper based systems or electronic databases, this course will focus on effective ways to meet the requirements of the standards at any stage in the drug lifecycle.
Who Should Attend:
Managers or Personnel who are required to work in a GMP/GLP Environment.