Auditing QC and Contract Laboratories for GMP Compliance 2015 is a webinar that covers topics such as:
- FDA and international requirements for laboratory audits
- Why are internal audits important
- Developing an SOP for `FDA Inspection Like` audits
- FDA and EMA inspections as models for laboratory audits
- The audit team: members, tasks, responsibilities
- Developing an audit schedule
- Looking at the right documentation
- Most critical audit areas based on risk assessment
- Audit items along the sample and data workflow from sampling to record archiving
- Auditing the laboratory quality system
- The importance of the exit meeting
- Assessment through laboratory walkthrough
- Follow-up with corrective and preventive actions: Going through six case studies
- Writing the audit report
Auditing QC and Contract Laboratories for GMP Compliance 2015 is intended for:
- Lab supervisors and managers
- GMP auditors – internal and external
- QA managers and personnel
- Analysts and other laboratory staff
- Consultants
- Training departments
