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Two Day Virtual Data Integrity Course: FDA, WHO and EMA's Requirements - November 15th-16th, 2021 - ResearchAndMarkets.com

·2-min read

DUBLIN, October 28, 2021--(BUSINESS WIRE)--The "Data Integrity: FDA, WHO and EMA's Requirements" training has been added to ResearchAndMarkets.com's offering.

The objective of this two day seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program and how to maintain Quality Systems that minimise these issues.

This seminar is designed to assist in assuring that your organisation is maintaining itself within cGMP compliance.

Case studies to include Warning Letters will be discussed to illustrate the wide array of issues that continue to arise and how to find them within your organisation and your vendors before the regulators find them for you.

This seminar represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.

Key Topics Covered:

DAY 01 (10:00 AM - 4:00 PM EDT)

10.00 AM: Session Start

  • Overview of Data Integrity - The issues

    • Background

    • Purpose/Objective

  • Definitions

    • Key definitions within the subject of Data Integrity

    • Data Integrity

    • Metadata

    • Audit Trail

    • Systems

  • Determination of the Key Regulatory Requirements to maintain Data Integrity

    • GMP requirements of Data Integrity

    • 21 CFR 210, 211, and 212 - an explanation of the most common CFR sections

  • The Most Prevalent 2015 Observations Associated with Data Integrity

    • A Review of Nineteen Observations

    • Why do they Repeat Year after Year

  • A Summary of Data Integrity Issues within:

    • In-coming Materials

    • Manufacturing

    • Laboratory

    • Training

    • Finished Products

    • Documentation

    • Product Release

DAY 02 (10:00 AM - 4:00 PM EDT)

  • Key Issues Associated with Data Integrity to include:

    • Exclusion of Data from Decision Making

    • Validation of Workflow

    • Restriction to Computer System Access

    • Data Integrity Remediation

    • And Many more

  • Breakout for Case Studies

  • Discussion of Case Studies to include recommendations

  • The breathe of falsification to include laboratory, stability, microbial and batch testing - where did they go wrong?

    • Hemofarm - Serbia - Microbiological Issues

    • Unimark - Basic issues with Data Integrity

    • Megafine Pharma Limited - Liquid Chromatography

    • Micro Labs LTD - Laboratory Records

  • Why Import Alerts may share Early Warning Issues

  • Why do fraudulent records continue to appear - despite a history of Warning Letters

  • Avoiding Responsibility through Contract Manufacturing and Testing Facilities - Does this work?

  • Case Studies and recent Warning Letters

For more information about this training visit https://www.researchandmarkets.com/r/1lwm4a

View source version on businesswire.com: https://www.businesswire.com/news/home/20211028005537/en/

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

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