The purpose of this three-day education course is to give participants a comprehensive overview of FDA’s current compliance requirements (21 CFR Part 211, Guidances for Industry, Compliance Program Guide, etc.) and expectations in these and related areas, and how they can be managed effectively.
The format allows each of our speakers to give an overview of the specific regulatory requirements associated with their topic prior to describing the approach to managing the issues with respect to philosophy, documented procedures, SOPs, etc.
In addition, the programme includes four workshop sessions covering:
Method Validation
Out of Specification Results
Validation of Excel Spreadsheets
Method Transfer
The course will also discuss the implication of new developments resulting from recent FDA and USP initiatives, such as analytical lifecycle management with continuous monitoring, data integrity, ….
Background
A major consequence of the Barr Ruling in 1993 was the significantly greater emphasis FDA inspections placed on the management and performance of quality control laboratories particularly the handling of Out of Specification results.
As a result of the increased and on-going scrutiny of analytical performance it is hardly surprising that even today the most frequently cited cGMP non-compliances are still found in laboratories, particularly:
General cGMP understanding and particularly relating to compliance with written procedures
Validation, performance and transfer of analytical procedures
Data integrity
Management of out of specification and suspect test results
Instrument qualification including an explanation of the new version of USP <1058>and calibration
Computer validation (including the requirements and actual interpretation of 21 CFR Part 11)
Operator training
Management of reagents and standards
Take advantage of this course to discuss all these issues.
Target Group
This course will be of significant value to:
All quality control managers responsible for FDA compliance in their laboratories
Senior laboratory staff charged with meeting these requirements day-to-day
All support staff involved in FDA inspections in their companies
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)
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
Validation of Analytical Procedures
Regulatory requirements (ICH, FDA, compendia)
Lifecycle approach (3-Stage-Model according to 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
Stability Testing
Regulatory requirements for stability testing of drug substances and drug products
Types of stability studies
Storage conditions requirements according to climatic zones
Stability protocol and reports
Establishment of storage conditions and shelf-life
Stability testing for post-approval changes
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
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
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
Practical Computer Validation in Analytical Laboratories
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!
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?
Four Workshops Some of the most important laboratory compliance topics will be further discussed in interactive workshops:
Topic I: Method Validation Moderator: Dr JOACHIM ERMER
Topic II: Out of Specification Results Moderator: Dr JOACHIM ERMER
Topic III: Validation of Excel Spreadsheets Moderator: Dr BOB McDOWALL
Topic IV: Method Transfer Moderator: Dr MANFRED FISCHER
Transfer of Analytical Procedures
USP General Chapter <1224>Transfer of Analytical Procedures (TAP)
Key steps for a successful method transfer: - 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
Validation of Excel Spreadsheets
Excel spreadsheets are used widely in analytical laboratories as it is easily available and easy to use - and equally so, it is easy to misuse
Technical features available in Excel
Practical ways to validate Excel spreadsheets
Protection of the electronic records produced
Problems of complying with 21 CFR Part 11 and the new EU GMP Annex 11 Requirements
Training Case Study
Legal requirements
Education/GMP-training/Training on the job
Training records
Re-training frequency
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
Testimonials
Seminar Programme as PDF