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.
- 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
Staff involved with GMP and GDP regulated activities in pharmaceutical development, manufacturing and distribution companies:
- Quality Assurance
- Quality Control
- Supply Chain/Outsourcing
- Regulatory Affairs
- Research and Development
- API Manufacturers
- GMP/GDP Compliance
- Contract Manufacturing Organizations
- Contract Testing Laboratories