Risk Assessment Methods – One Size Does Not Fit All
Risk assessment is a key competency for modern Pharma/Biopharma organizations. Since the publication of ICH Q9 “Quality Risk Management” in 2005, the…
Reviewing Documents 101
When it comes to reviewing documents such as batch records, qualifications, validations, and other important documents, there are certain…
Quality 101 for Cannabis Products
Quality is the driving factor that keeps our food system safe. In the United States, there is an unspoken…
Wrapping Up the Inspection
This series on inspection success has stressed the importance of making a good first impression, preparing your inspection management team, using inspection management…
A Deviation has Occurred. What’s Next?
Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error…
The Importance of Validation
Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence…
