This is a course to help pharmaceutical, biotechnology, medical device, and biologics professionals help to prepare and manage Quality Control Laboratories in a compliant, systematic, effective and skillful manner.  The course will go over key cGMP requirements for both the analytical and microbiological QC laboratories and include detailed information on the instrument qualification, QC sample management, method validations, data integrity and QC audits/inspection preparations.

Topics Covered:

• Relevant cGMP, ICH, USP and other Health Authority Expectations for QC Laboratories
  • Trends in Health Authority Findings Specific to QC
• QC Instrumentation Qualification, Maintenance and Calibration
  • Risk Analysis on Equipment Types
  • USP requirements on Method Validation, USP <1058>
  • Qualification Requirements:  DQ/IQ/OQ/PQ
  • Computer Systems (21 CFR Part 11) and Audit Trails
  • Examples of Qualification for HPLC, Balances, FTIR, UV Spectrophotometer
• QC Sample Management
  • Sample Receipt to Reconciliation
  • Logbooks and/or LIMS
  • Reference Standard Qualification and Oversight
  • Retention Sample Program
  • Sample Storage and Shipping
• Key QC / QA Procedures and ControlsLaboratory OOS and OOT and retesting
  • QC Data Review and Data Management
  • Corrective and Preventative Actions (CAPA)
  • Change Controls
  • QC Reagent and Chemical Handling and Expiration Dating
  • Oversight of Contract Laboratory Organizations (CLOs)
• QC Method Validations
  • Phase Appropriate Method Validation
  • Qualitative versus Quantitative
  • Compendial Qualification/Validation Guidelines
  • Training Requirements
• QC Microbiology Laboratory Controls
  • Laboratory Set-Up
  • Media qualification and growth promotion
  • QC Microbiology Tests and Expectations
• Health Authority and Audits of the QC AreasCase Studies throughout
  • Lab Walk-throughs
  • Data Integrity
  • Personnel Training Program
  • Stability Program
  • Inspection or Audit Checklists

Target Audiences:

• Quality Control Analysts and Lab Supervisors
• Data Reviewers
• Analytical Scientists
• Quality Assurance
• Validation Specialists
• Microbiologists
• Qualification, Preventative Maintenance and Calibration Teams
• Internal and External Auditors
• Training Departments
• Regulatory Affairs
• Compliance Officers
• Senior Management
• Cross-functional Teams