DUBLIN–(BUSINESS WIRE)–The “Virtual Seminar on GAMP Data Integrity 21 CFR Part 11 Training Course” training has been added to ResearchAndMarkets.com’s offering.
This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies.
Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle.
What You Will Learn
This training course will provide a practical understanding of the following:
The current regulatory focus on Data Integrity Relevant regulatory observations Recent regulatory Guidance on Data Integrity The need for Data integrity throughout the system and data life cycles The requirement for a data governance framework How to meet the international regulatory requirements for electronic records and signatures How to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the FDA interpretation in the Scope and Application Guidance How to meet the requirements of other relevant regulations including EU Annex 11 How to apply the current industry risk-based good practice approach to compliant electronic records and signatures How to maintain Data Integrity through the operation phase of the GAMP life cycle How new technologies such as cloud computing and mobile applications can impact data integrity How to apply the new ISPE GAMP Guide: Records and Data Integrity including: Data Governance Framework Culture and Human Factors Data Life Cycle Applying Quality Risk Management to Data Integrity Agenda
Introduction Data Integrity through the Lifecycle MHRA Data Integrity Guidance Regulatory Citations for Data Integrity Data Governance EU Annex 11 and Chapter 4 Compliant Operation of GxP Regulated Systems 21 CFR Part 11 Electronic Records and Signatures Data Integrity for Spreadsheets Mobile Devices and Cloud Computing ISPE GAMP Guide on Record and Data Integrity For more information about this training visit https://www.researchandmarkets.com/r/988zl1