ComplianceOnline

GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry

Instructor: Angela Dunston
Product ID: 704454
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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Read Frequently Asked Questions

This training program will discuss MHRA GMP data integrity definitions and guidance. It will also highlight the difference between intentional and unintentional failures of data integrity and examine how regulatory agencies detect data integrity problems.

Why Should You Attend:

The pharmaceutical industry is expected to make arrangements to ensure that the accuracy, completeness, content, and meaning of data are retained throughout the data lifecycle. Failure to adhere to regulatory expectations can lead to recall, warning letters, import bans and criminal action.

This webinar will offer MHRA GMP data integrity definitions and guidance and help identify tell-tale signs that you have data integrity problems. The program will also engage participants in how to develop a remediation plan to decrease risk to an acceptable level in your operations.

Learning Objectives:

  • MHRA GMP data integrity definitions and guidance
  • How to examine your supply chain and development programs with the use of quality
  • Risk management to identify where risk of data integrity lapses are present
  • The tell-tale signs that you have data integrity problems
  • To tell the difference between intentional and unintentional failures of data integrity
  • How to develop a remediation plan to decrease risk to an acceptable level in your operations
  • How to be proactive in areas the FDA is silent by learning from the Europeans and being ahead of the game
  • How regulatory agencies detect data integrity problems

Areas Covered in the Webinar:

  • Introduction
  • What is data integrity?
  • The impact of data integrity issues
  • Where can data integrity failures happen?
  • How to know when it happens
  • Intentional and unintentional types of failure
  • How to get to the root cause of data integrity failures
  • The long slow route to repairing the damage of failures
  • What the EU is saying via the MHRA guidance
  • Warning letters tell you how it is detected by the FDA
  • How to prevent data integrity failures from happening
  • Conclusion

Who Will Benefit:

  • Pharmaceutical manufacturers dealing with solid dosage, vaccines and biologics
  • Personnel in contract laboratories
  • API manufacturers
  • Medical device manufacturers

Instructor Profile:

Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining quality management systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Ms. Dunston has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, she has worked with US FDA agents to ensure compliance for her clients.

Her international experience has assisted global organizations such as Johnson and Johnson, The Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has offered trainings on procedures from the V-suite to the manufacturing floor. Ms. Dunston works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.

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