Recording Online Training - FDA Compliance in Analytical Laboratories<br>Im Auftrag der ECA Academy

Recording Online Training - FDA Compliance in Analytical Laboratories<br>Im Auftrag der ECA Academy

Kosten

ECA-Member*: EUR 1590,--
Non ECA Member*: EUR 1790,--
EU/GMP Inspectorates*: EUR 895,--
APIC Member Discount*: EUR 1690,--

Alle Preise zzgl. MwSt.

* auch unkompliziert per Kreditkarte bezahlbar American Express Visa Mastercard

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

Sprecher

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

Zielsetzung

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, ...

Hintergrund

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 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.

Zielgruppe

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

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programm

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
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
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
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?
Qualification of Analytical Instruments in the QC
  •  Legal requirements (cGMP, CFR, etc.)
  •  USP General Chapter Analytical Instrument Qualification
  •  Qualification Phases (DQ/IQ/OQ/PQ)
  •  Qualification examples (problems and solutions)
  •  Analytical instrument life-cycle (Requalification, etc.)
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)

Transfer of Analytical Procedures
  •  USP General Chapter 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
Training Case Study
  •  Legal requirements
  •  Education / GMP-training / Training on the job
  •  Training records
  •  Re-training frequency

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
Validation of Analytical Procedures
  •  Regulatory requirements (ICH, FDA, compendia)
  •  Lifecycle approach (3-Stage-Model according to draft USP General Chapter ))
  •  Verification of compendial procedures
  •  Rationale design of validation studies
  •  Identification of relevant performance parameters
  •  Sensible use of statistics
  •  Suitable performance parameters for continuous monitoring
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!
Practical Computer Validation in Analytical Laboratories (Part II)
 
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

 

Speakers

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

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 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

Programme

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
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
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
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?
Qualification of Analytical Instruments in the QC
  •  Legal requirements (cGMP, CFR, etc.)
  •  USP General Chapter Analytical Instrument Qualification
  •  Qualification Phases (DQ/IQ/OQ/PQ)
  •  Qualification examples (problems and solutions)
  •  Analytical instrument life-cycle (Requalification, etc.)
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)
Transfer of Analytical Procedures
  •  USP General Chapter 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
Training Case Study
  •  Legal requirements
  •  Education / GMP-training / Training on the job
  •  Training records
  •  Re-training frequency
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
Validation of Analytical Procedures
  •  Regulatory requirements (ICH, FDA, compendia)
  •  Lifecycle approach (3-Stage-Model according to draft USP General Chapter ))
  •  Verification of compendial procedures
  •  Rationale design of validation studies
  •  Identification of relevant performance parameters
  •  Sensible use of statistics
  •  Suitable performance parameters for continuous monitoring
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!
Practical Computer Validation in Analytical Laboratories (Part II)
 
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

 

Recording from 6/7 October 2020
Duration of Recording: appr. 10 h 30 min

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