Data Integrity and ALCOA+ Principles Training
Data integrity training.
2 000 Skr
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Purpose:
Provides structured training content on data integrity principles, including ALCOA+, to support the generation, handling, and maintenance of accurate, complete, and reliable GMP data throughout the data lifecycle.
Regulatory Alignment:
Aligned with EU GMP data integrity expectations, including EMA and MHRA guidance, and consistent with ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System).
Included Files:
• Data integrity and ALCOA+ training material
• Data lifecycle and critical data overview
• Illustrative examples and discussion points for GMP environments
Format:
Microsoft PowerPoint or Microsoft Word (fully editable)
Intended Users:
Pharmaceutical manufacturers, quality assurance, quality control, manufacturing, and technical personnel responsible for creating, reviewing, or managing GMP data.