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Online Webinar
09 Feb 2016
Science

Webinar on GMP Data Integrity Best Practices

Regulatory Expectations for the Pharmaceutical Industry

Description :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 - OverviewThe impact of data integrity issuesWhere can data integrity failures happen?How to know when it happensIntentional and unintentional types of failureHow to get to the root cause of data integrity failuresThe long slow route to repairing the damage of failuresWhat the EU is saying via the MHRA guidanceWarning letters tell you how it is detected by the FDAHow to prevent data integrity failures from happeningConclusions Who Will Benefit:Senior ManagementQuality Assurance DepartmentQuality Control DepartmentCompliance Auditors and ManagementProcess Development Scientists and ManagementSupply Chain and Logistics ManagersRegulatory Affairs ProfessionalsEngineering DepartmentPharmaceutical Manufacturers of Solid Dosage, Vaccines, BiologicsContract LaboratoriesAPI ManufacturersDevice ManufacturersIT Management and Staff working in Regulated areas

When

9 Feb 2016 @ 02:00 pm

9 Feb 2016 @ 02:00 pm

Duration: 0 hours

Timezone: GMT -5:00


Where

Online Webinar


Language

English en


Organised by

Compliance Trainings (deactivated)
Speakers

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