GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry
Instructor:
Angela Dunston
Product ID: 704454
- Duration: 90 Min
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
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.
Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
