Laboratory Operations, Analyzers, R&D, R&T
Pharmaceutical Laboratories Skills
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Pharmaceutical Laboratories Skills Course
Introduction:
This course is intended to give technical, supervisory, and supporting Quality Assurance staff in the pharmaceutical laboratory thorough guidance and hands-on assistance on approaches to take and things to look out for when performing GMP analysis of pharmaceutical, biopharmaceutical, and biological samples.
Course Objectives:
The course will address the current regulatory framework for laboratory work conducted to support GMP activities with reference to development, release, and stability testing of Investigational and Commercial products. Comparison with relevant Good Laboratory Practices, in support of pre-clinical studies, will be made.
Who Should Attend?
- Technical personnel within the laboratory
- Laboratory supervisors and managers
- Quality assurance personnel supporting the laboratories/activities
Course Outlines:
- Introduction to the Regulations Relevant to Laboratory Work
- A review of EU GMP regulations and a comparison with GLP requirements
- What Does the Laboratory Do?
- Assay types undertaken, method validation, data from generation to reporting, electronic records
- When Things Go Wrong
- Deviations, OOS, investigations, complaints, corrective and preventive action.
- Workshop 1 – OOS Results and Deviations
- Laboratory Equipment Qualification and Maintenance
- Approaches to qualification and maintenance, considering risk, simple versus complex equipment.
- GMP Work in a GLP Laboratory
- Differences between GMP and GLP requirements, QA input to OOS and deviations, auditing, and report approval.
- Workshop 2 – Contract Testing
- Regulatory Inspection Findings in Laboratories
- Regulatory inspection programs, expectations, and common findings.
- Questions and Answers