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

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 be a detailed discussion about GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry. We will also review the New MHRA GMP Data Integrity Definitions and Guidance Release in January & What to Expect from the FDA in the Future.

Areas Covered in the Session :
Data Integrity – Overview
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

Who Will Benefit:
Senior Management
Quality Assurance Department
Quality Control Department
Compliance Auditors and Management
Process Development Scientists and Management
Supply Chain and Logistics Managers
Regulatory Affairs Professionals
Engineering Department
Pharmaceutical Manufacturers of Solid Dosage, Vaccines, Biologics
Contract Laboratories
API Manufacturers
Device Manufacturers
IT Management and Staff working in Regulated areas

Angela K. Dunston

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, Angela 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, Angela has worked with US FDA agents to ensure compliance for her clients.

The international experience obtained 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 trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.

  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT

  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance