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Data Integrity in the Pharmaceutical Industry
This Webinar is over| Date | Nov 7, 2018 |
| Time | 12:00 PM EDT |
| Cost | $200.00 |
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Online
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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.
Areas Covered in the Session :
Who Should Attend:Staff involved with GMP and GDP regulated activities in pharmaceutical development, manufacturing and distribution companies:
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
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