This course will explore why auditing laboratories is the ideal tool to verify compliance of laboratory practices. It will guide attendees in preparing for FDA inspections, while detailing documentation requirements for the FDA and ISO.
Why Should You Attend:
Quality control laboratories are considered high risk since, after testing and approval, pharmaceutical drug products and APIs are released to the market without further check. It's also the reason why FDA and other agencies lay heavy emphasis on inspection of QC laboratories. The large number of recent QC related 483s and warning letters prove that companies have issues in complying with regulations. Auditing laboratories is an ideal tool to verify compliance of laboratory practices with regulations and to prepare your organization for regulatory inspections. This webinar will help attendees learn how to use internal audits of QC laboratories as excellent preparation for FDA inspections. The instructor will also offer best practice guidelines for effective implementation.Areas Covered in the Webinar:
- Why are internal audits important
- FDA and international requirements for laboratory audits
- FDA and EMA inspections as models for laboratory audits
- Developing an SOP for 'FDA Inspection Like' audits
- Developing an audit schedule
- The audit team: members, tasks, responsibilities
- Most critical audit areas based on risk assessment
- Looking at the right documentation
- Auditing the laboratory quality system
- Audit items along the sample and data workflow from sampling to record archiving
- Assessment through laboratory walkthrough
- The importance of the exit meeting
- Writing the audit report
- Follow-up with corrective and preventive actions: Going through six case studies
Who Will Benefit:
- GMP auditors - internal and external
- Lab supervisors and managers
- Analysts and other laboratory staff
- QA managers and personnel
- Training departments
- Consultants
Course Provider
Dr. Ludwig Huber,
