Qualification and Validation Essentials Training (EU GMP Annex 15)
Validation lifecycle training.
2 000 SEK
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Purpose:
Provides structured training content on the principles and regulatory expectations for qualification and validation activities in accordance with EU GMP Annex 15, supporting a lifecycle-based approach.
Regulatory Alignment:
Aligned with EU GMP Annex 15 requirements for qualification and validation and consistent with ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System).
Included Files:
• Qualification and validation essentials training material
• Overview of qualification stages and validation lifecycle concepts
• Illustrative examples and discussion points aligned to Annex 15 expectations
Format:
Microsoft PowerPoint or Microsoft Word (fully editable)
Intended Users:
Pharmaceutical manufacturers, quality assurance teams, engineering, validation, and technical personnel involved in GMP qualification and validation activities.