Programme 06 October 2020
09.00 – 09.15 h Introduction
09.15 – 10.00 h
General Aspects: Regulatory Requirements and FDA Inspections
- Regulatory Overview (US, Europe and the world)
- Regulatory requirements in the US (cGMP, CFR, Guidances for Industry, etc.)
- FDA Inspections
- Key issues during laboratory inspections
- 483s and Warning Letters
10.00 – 10.45 h
Sampling in Compliance with FDA Requirements
- Importance of the sampling procedure
- Regulatory requirements
- Sampling statistics / sampling plans
- Sampling procedures
- Sampling equipment and environment
- Training
- Retained samples
10.45 – 11.00 h
Questions & Answers
11.00 – 11.15 h Break
11.15 – 12.00 h
Documentation for Quality Control Laboratories
- “Scientifically sound” GMP requirements of QC documents and approaches
- Types of QC laboratory documents:
- Test specifications and analytical procedures
- Standard Operating Procedures
- Instrument qualification protocols
- Complete data for analytical testing and Certificates of Analysis
- Compare and contrast FDA and EU documentation requirements
- Management of blank forms and data integrity issues
12.00 – 13.00 h Break
13.00 – 13.45 h
FDA Approaches to Laboratory Data Integrity
- FDA laboratory observations: falsification and fraud
- Compliance Program Guide 7346.832 on Pre-Approval Inspections: Objective 3 - Laboratory data integrity
- FDA inspector training: focus on the computer system not paper printouts
- What controls do you need to have in place to ensure data integrity?
13.45 – 14.30 h
Questions & Answers
14.30 – 14.45 h Break
14.45 – 15.30 h
Qualification of Analytical Instruments in the QC
- Legal requirements (cGMP, CFR, etc.)
- USP General Chapter <1058> Analytical Instrument Qualification
- Qualification Phases (DQ/IQ/OQ/PQ)
- Qualification examples (problems and solutions)
- Analytical instrument life-cycle (Requalification, etc.)
15.30 – 16.15 h
Calibration for FDA Inspected Analytical Laboratories
- General approach to Calibration
- Instrument calibration in the USP
- Contrasting US and European approaches (important in the context of laboratories struggling to meet both requirements)
16.15 – 16.35 h
Questions & Answers
approx. 16.35 h End of Day 1
Programme 07 October 2020
08.30 – 09.15 h
Transfer of Analytical Procedures
- USP General Chapter <1224>Transfer of Analytical Procedures (TAP)
- Key steps for a successful method transfers:
- Initiation phase (training method familiarization, etc.)
- Types of transfer
- Analytical procedures
- Materials (samples and standards) and testing design
- Instruments
- Data assessment – Acceptance criteria
- Documentation (transfer protocol / report)
- Summary
09.15 – 09.30 h
Questions & Answers
09.30 – 10.15 h
Training Case Study
- Legal requirements
- Education / GMP-training / Training on the job
- Training records
- Re-training frequency
10.15 – 11.00 h
Out of Specification Results
- Requirements of the FDA Guidance
- Efficient laboratory investigations
- Reanalysing, retesting, resampling
- Management of variability-caused OOS results
- Investigation of atypical results
- Proactive strategies to prevent OOS results
11.00 – 11.15 h
Questions & Answers
11.15 – 12.00 h
Validation of Analytical Procedures
- Regulatory requirements (ICH, FDA, compendia)
- Lifecycle approach (3-Stage-Model according to draft USP General Chapter <1220>))
- Verification of compendial procedures
- Rationale design of validation studies
- Identification of relevant performance parameters
- Sensible use of statistics
- Suitable performance parameters for continuous monitoring
12.00 – 12.15 h
Questions & Answers
12.15 – 13.15 h Break
13.15 – 14.00 h
Practical Computer Validation in Analytical Laboratories (Part I)
- Computerised system validation as a critical activity in the analytical laboratory
- 21 CFR Part 11 compliance
- FDA emphasis on data integrity for computerised systems
- GAMP software categories and impact on validation approach
- GAMP Good Practice Guide for Validation of Laboratory Systems second edition
- Case study examples: how to validate systems in a cost effective way and steps of what not to do!
14.00 – 14.15 h
Questions & Answers
14.15 – 15.15 h
Practical Computer Validation in Analytical Laboratories (Part II)
15.15 – 16.00 h
Reference Standards and Reagents for FDA-Inspected Laboratories
- Regulatory requirements
- Types of reference standards: Official/primary/working standards/reference materials
- Traceability, characterisation, and retest date of standards
- Risk-based approach for management, storage and shelf-life of laboratory reagents and solutions
- Stability investigation of solutions for quantitation
16.00 – 16.20 h
Questions & Answers
approx. 16.20 h End of the Live Online Training