Speakers

Jörg Kastenschmidt

Merck Healthcare

Dr. Joachim Ermer

Ermer Quality Consulting

Dr Manfred Fischer

Manfred Fischer Consulting

Dr. Bob McDowall

R.D. McDowall Ltd.

Objectives

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, ...

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

Technical Requirements

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

At http://www.webex.com/test-meeting.html 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

Live Online Training - FDA Compliance in Analytical Laboraties

Seminar Programme as PDF

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

This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more

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E-Mail: info@gmp-compliance.org

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