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
Key definitions within the subject of Data Integrity
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:
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/
Laura Wood, Senior Press Manager
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