Data Integrity in the Pharmaceutical Industry

Data integrity is essential to regulatory compliance within the pharmaceutical industry. MHRA, FDA and WHO have all issued guidances on data governance, and assurance of data integrity forms a key part of regulatory inspections. Recent Warning Letters to pharmaceutical companies have highlighted data integrity failures.

The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of working, for example, via third party service providers. Systems to support these ways of working can range from manual processes with paper records to the use of fully computerised systems. The main purpose of the regulatory requirements remains the same, i.e. having confidence in the quality and the integrity of the data generated (to ensure patient safety and quality of products) and being able to reconstruct activities.

This webinar is designed for staff who are new to data integrity requirements in the pharmaceutical industry or who wish to learn about the latest regulatory guidances.

Areas Covered in the Session :

• Understanding data integrity?
• How does data integrity apply to GxP?
• Recent data integrity findings in regulatory inspections
• Human factors in data integrity failures
• What does industry have to do?
• MHRA, FDA and WHO guidances

Who Should Attend:

Staff involved with GMP and GDP regulated activities in pharmaceutical development, manufacturing and distribution companies:

• Quality Assurance
• Quality Control
• Manufacturing
• Warehousing
• Supply Chain/Outsourcing
• Regulatory Affairs
• Research and Development
• API Manufacturers
• GMP/GDP Compliance
• Contract Manufacturing Organizations
• Contract Testing Laboratories

Course Director: ROBERT HASLAM

Robert Haslam, Managing Director, Somerset House Consultants has over forty years of experience in Quality Assurance, Production, Development, Clinical Trials and Regulatory Affairs gained in multinational and start-up companies. He is the Managing Director of a consultancy providing quality assurance, manufacturing, development and training support to pharmaceutical companies worldwide. He is an EU ‘Qualified Person’ for marketed and investigational products, including steriles and non-steriles, generics, biopharmaceuticals, herbals. He is also an ISO-qualified Lead Auditor; experienced in EU & FDA Good Manufacturing Practice. He has extensive experience in GMP audits of drug substance, drug product and Investigational Medicinal Product manufacturers; outsourced activities; supply chain risk management. He has a successful track record of strategic management, facility qualification, designing and implementing quality systems, managing quality remediation programs, product development and outsourcing. He has designed and delivered bespoke GMP training courses to companies worldwide. Expert witness in litigation involving GMP compliance.