Overview
Data integrity is essential to regulatory compliance within the pharmaceutical industry. This webinar will introduce the recent MHRA, FDA and WHO guidances on data governance and assurance of data integrity.
Why you should Attend
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.
Areas Covered in the Session
- What is data integrity and why do we need it?
- How does data integrity apply to GXP?
- FDA, MHRA and WHO data integrity guidances
- What are 'critical data'?
- Principles of data integrity - ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)
- Risks to data integrity - how to do risk assessments
- How to design robust data systems
- Human factors in data integrity
- Human factors in data integrity failures
- Computerised system access controls
- Data review and audit trails
- Recent data integrity findings in regulatory inspections
- E-signatures
- What does industry have to do?
Learning Objectives
- Understanding of data governance and data integrity as applied to medicinal products. What do you need to do to comply with regulators expectations
Who Will Benefit
- Manufacturing
- Quality Assurance/Quality Control
- IT
- R&D
- Regulatory Affairs
- Supply Chain
- Wholesalers
Speaker Profile
Robert Haslam is a pharmaceutical industry VP with 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.
Instructor
Robert Haslam