Resources

Government Websites:
U.S. Food and Drug Administration                                
FDA Center for Biologics Evaluation and Research                 
FDA Center for Drug Evaluation and Research              
FDA Center for Devices and Radiological Health           
FDA Center for Veterinary Medicine                               
FDA Center for Food Safety and Applied Nutrition                 
FDA Office of Combination Products       
FDA Office of Regulatory Affairs                                 
U.S. Environmental Protection Agency                     
EPA Office of Pesticides, Prevention and Toxic Substances        
EPA Office of Pesticide Programs                         
EPA Office of Water                                              
California Environmental Protection Agency                       
California Department of Pesticide Regulation          

GLP and Quality Assurance Resources:
Society of Quality Assurance 
                                    
Regulatory Affairs Professionals Society                         
Organization for Economic Cooperation and Development    
International Organization for Standardization   
AOAC International                                               
U.S. Pharmacopeia                                                
ASTM International                                               

Validation Specialists:
Computer and 21 CFR Part 11
Process, Equipment and Installation Qualification

                                                          

 

 

Quality & Validation Services

 

Consultants:
Debra Bridges - Medical Devices 

GCP consulting:  ddgay@msn.com
                                   llisansky@aol.com

GCP Consulting:  karl@qualityvalidation.com

 

Part 11 Training & QA Systems Development:
LPL Quality Services

Facility Construction Project Management:
Total Project Services

 

cGMP Processes:
Cychem, Inc.


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