GMP Compliance for Quality Control and Contract Laboratories

Date	Aug 16, 2018
Time	03:00 PM EDT
Cost	$17125.00
Online

Quality control laboratories are considered high risk because after testing and approval pharmaceutical drug products and APIs are released to the market without further check. That’s the reason why FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483’s and warning letters demonstrate that companies have problems with implementation.

Reference material for easy implementation:

• Laboratory compliance master plan
• SOP: Handling OOS results
• SOP: Handling OOT results

Areas Covered in the Session :

• FDA and international regulations and guidelines
• Most frequently found deviations during inspections
• Major differences between GMP and non GMP laboratories
• Compliance along the laboratory workflow
• Developing a laboratory compliance master plan
• Developing a project plan for step-by-step implementation
• Implementing key requirements
  • Writing GMP compliant laboratory SOPs
  • Correct sampling and sample handling
  • Qualification and maintenance of equipment
  • Validation of analytical methods
  • Handling out-of-specification situations, preventive and corrective actions
  • Qualification of suppliers and reference material
  • Acquisition, maintenance and archiving of records
• Preparation for FDA inspections
• Recommendations for implementation

Who Should Attend:

• Laboratory managers and supervisors
• GLP/GCP/GMP auditors
• ISO 17025 auditors
• QA/QC managers and personnel
• Analysts and other laboratory staff
• Regulatory affairs
• Training departments
• Consultants