Good Documentation Practices - Preparing SOP’s and Batch Documentation
Understand the key role SOPs & MBRs play in the overall quality of the products and compliance system
Computer Software Validation
Understand the methodology used to validate a computer-related system
Data Integrity
DI of the computerized systems has become one of the key areas of strong emphasis for regulatory agencies such as Food and Drug Administration (FDA-US), and EU.
Life-Cycle Approach of Cleaning Validation
From 2000 to 2010 around 35% of the "Warning Letters" from the FDA contained remarks on cleaning and cleaning validation!
Good Hygienic Practices
Is Your Personnel Hygiene Plan Up To Date?
Good Storage and Distribution Practices (GSDP)
Get familiar with the Principles of the GDP Quality System and Quality Management
cGMP Compliance and Inspection
Prepare yourself and Your Company for tougher cGMP Compliance Audits
Root Cause Analysis and Developing an Effective CAPA Strategy
Have you ever had a deviation occur that forced you to retrain staff?
