FDA Compliance in Analytical Laboratories

(Im Auftrag der European Compliance Academy)

FDA Compliance in Analytical Laboratories <p>(Im Auftrag der European Compliance Academy)

Berlin, Germany

Seminar Nr. 9205


Die Veranstaltung hat bereits stattgefunden

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Dr Christopher Burgess, Burgess Analytical Consultancy
Dr Joachim Ermer, Sanofi
Dr Manfred Fischer, SkyePharma
Dr Bob McDowall, McDowall Consulting


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 Manual, etc.) and expectation 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 initiatives.


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, and 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
Equipment qualification and calibration
Computer validation (including the requirements and actual interpretation of 21 CFR Part 11)
Operator training

Take advantage of this course to discuss all these issues.


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


General Aspects: Regulatory Requirements and FDA Inspections
Regulatory requirements (cGMP, CFR, Guidances for Industry, etc.)
FDA Inspections
Quality System Inspections (QSIT)
Key issues during laboratory inspections
483s and Warning Letters
FDA’s ‘Pharmaceutical cGMPs for the 21st Century: A Risk-based Approach’ Initiative
‚Process Analytical Technology‘ (PAT) initiative
Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Qualification of Analytical Instruments in QC Laboratories
Legal requirements (cGMP, CFR, etc.)
USP General Chapter <1058> Analytical Instrument Qualification
Qualification Phases (DQ/IQ/OQ/PQ)
Case study: Qualification of a NIR-spectrophotometer
NIR Monograph: USP vs. EP
Change Control
Analytical instrument life-cycle (Requalification, etc.)
Dr Manfred Fischer, SkyePharma, Switzerland

Calibration for FDA Inspected Analytical Laboratories
Requirements in the USP for instrument calibration
Contrasting US and European approaches (important in the context of laboratories struggling to meet both requirements)
ISO Guide 17 025 requirements
Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Reference Standards and Reagents for FDA-Inspected Laboratories
Regulatory requirements
Official/primary/working standards
Traceability of standards
Purity and characterisation of reference standards
Handling, storage and shelf-life of reference standards and reagents
Dr Joachim Ermer, Sanofi, Germany

Validation of Analytical Procedures
Regulatory requirements (ICH, FDA,compendia)
Holistic validation approach
Rationale design of validation studies
Relevant performance parameters
Sensible use of statistics
Lifecycle approach, new draft of FDA-Guideline
Dr Joachim Ermer, Sanofi, Germany

Stability Testing
Stability testing of drug substances and drug products
Stability testing for NDAs, ANDAs, and INDs
Stability protocol
Reporting stability data
Specific stability requirements
Stability testing for post-approval changes
Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Out of Specification Results
Requirements of the FDA Guidance
Efficient laboratory investigations
Reanalysing, retesting, resampling
Handling of atypical results
Dr Joachim Ermer, Sanofi, Germany

Documentation for Quality Control Laboratories
“Scientifically sound” GMP requirements of QC documents and approaches
Types of QC laboratory documents:
Test specifications
Standard Operating Procedures
Instrument qualification protocols
Complete data for analytical testing and Certificates of Analysis
Compare and contrast FDA and EU documentation requirements
Dr BOB McDOWALL, McDowall Consulting, UK

Sampling in Compliance with FDA Requirements
Importance of the sampling procedure
Regulatory requirements
Sampling statistics / sampling plans
Sampling procedures
Sampling equipment and environment
Retained samples
Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Practical Computer Validation in Analytical
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® Best Practice Guides for Laboratory Systems second edition and Part 11
Case study examples: how to validate systems in a cost effective way and steps of what not to do!
Validation Lite for low risk systems
Dr Bob McDowall, McDowall Consulting, UK

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
FDA Level 2 guidance on user identities and test injections
Dr BOB McDOWALL, McDowall Consulting, UK

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
Data assessment – Acceptance criteria
Documentation (transfer protocol / report)
Dr Manfred Fischer, SkyePharma, Switzerland

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 2007
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
Dr Bob McDowall, McDowall Consulting, UK

Training Case Study
Legal requirements
Education / GMP training / Training on the job
Training records
Re-training frequency
Dr Manfred Fischer, SkyePharma, Switzerland

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 Christopher Burgess

Topic III: Validation of Excel Spreadsheets
Moderator: Dr Bob McDowall

Topic IV: Method Transfer
Moderator: Dr Manfred Fischer


GMP Seminare nach Thema

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