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Home - About Bob Ferer
- Consulting Services
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- Clean Room Design
- The Contamination Control Plan
- Preparing for Systems-based Inspection
- Implementing an Effective Change Control System
- Assuring Confidence in Laboratory Data
- Hardware and Software Validation
- Design of HVAC Systems for Aseptic Facilities
- Using Spreadsheets in the Laboratory
- Sterile Filtration and Integrity Testing
- Managing Startup Project Teams
- Validation
- Keeping Equipment in a Validated State
- Regulatory Resources
- Contact
The Ferer Group Regulatory Resources
This page contains links to various regulatory agency web sites as well as current issues that face our industry. Check this page to stay abreast on the hot topics and suggestions on how to mitigate risk associated with the various issues.
Resources
Links
- EMEA – European Medicines Agency
- EU Regulations – Eudralex
- FDA CFR 21 Home Page
- FDA Guidance Page
- FDA Inspection Guides
- FDA Regulatory Procedures Manual
- Health Canada
- MHRA
- PIC/S Website
- WHO – World Health Organization
Useful to see what the FDA thinks about a specific topic
The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.
Medicines and Healthcare Products Regulatory Agency
Pharmaceutical Inspection Co-operation Scheme
