Live Online Training - FDA Compliance in Analytical Laboraties

Live Online Training - FDA Compliance in Analytical Laboraties

Course No 18318


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Dr Joachim Ermer, Sanofi, Germany
Dr Manfred Fischer, Skyepharma (member of Vectura group), Switzerland
Joerg Kastenschmidt, Merck, Germany
Dr Bob McDowall, Member of the ECA Data Integrity & IT Compliance Group, UK


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 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 and USP initiatives, such as analytical lifecycle management with continuous monitoring, data integrity, ...


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

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


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

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