GMP Compliance for Quality Control and Contract Laboratories 2018 covers topics such as:
- Most frequently found deviations during inspections
- FDA and international regulations and guidelines
- Compliance along the laboratory workflow
- Major differences between GMP and non GMP laboratories
- Developing a project plan for step-by-step implementation
- Developing a laboratory compliance master plan
- Writing GMP compliant laboratory SOPs
- Implementing key requirements
- Qualification and maintenance of equipment
- Correct sampling and sample handling
- Handling out-of-specification situations, preventive and corrective actions
- Validation of analytical methods
- Acquisition, maintenance and archiving of records
- Qualification of suppliers and reference material
- Recommendations for implementation
- Preparation for FDA inspections
GMP Compliance for Quality Control and Contract Laboratories 2018 intended for:
- GLP/GCP/GMP auditors
- Laboratory managers and supervisors
- QA/QC managers and personnel
- ISO 17025 auditors
- Regulatory affairs
- Analysts and other laboratory staff
- Consultants
- Training departments
