• understand why an efficient laboratory is typically a compliant laboratory
• know the key hot button issues FDA notes in QC laboratories
• learn the top ten issues FDA finds fault with laboratories during their inspections
• understand what it takes not to have negative FDA observations about your laboratory
• recognize the concept of being in control and what it takes to perform FDA acceptable investigations

Laboratory Management

• Managing for laboratory efficiency
• Standard analytical times
• Staffing requirements
• Laboratory space requirements
• Electronic records (21CFR11) — current status of FDA regulations and their impact on the lab
• Spreadsheet validation — what is required and how to do it
• Laboratory deviations, incidents and being in control
• Performing effective, acceptable out-of-specification (OOS) investigations and getting to root causes

Laboratory Analyst Training

•   The 13 core laboratory SOPs all analysts must know before beginning work
• Laboratory mathematics, manipulations and records
• Systematic errors
• Pharmacopoeias
• USP — mandatory elements, voluntary elements
• ICH guidelines
• FDA and their role in laboratory testing
• GMP/GLP requirements of laboratories and analysts
• Handling out-of-specification situations
• Handling out-of-trend situations
• FDA warning letters — tools for training

Method Development

•   Method development planning
• Assay simplicity and robustness
• Assay economics
• Analytical method life-cycle

Method validation

•  FDA expectations for analytical method validation
• Accuracy, precision, linearity
• Range, specificity, robustness
• ICH guideline requirements

Method Transfer

•   Method transfer from analytical development to method user
• Objective assessments of successful method transfer
• Lab-lab method transfer; analyst-analyst method transfer

Reference Standards

•  Primary standards
• Characterization of standards
• Working (secondary) standards
• Compendia standards
• Reagents and buffers — formulations and expiration dating

Instrument Calibration and Qualification

•   Instrument calibration fundamentals
• Calibration of pH meters, balances, incubators, refrigerators,
• IQ/OQ of laboratory water systems, stability chambers, GCs/HPLCs, spectrophotometers
• Instrument qualification explained

This course is designed for all staff involved with pharmaceutical quality control laboratories — chemical, physical and microbiological. This course will be of particular interest and applicability to QC lab managers, QA managers and QA auditors, analytical development lab managers and anyone involved with the healthcare manufacturing and research industries