Food and Drug Administration

Center for Drug Evaluation and Research

    

Advisory Committee for Pharmaceutical Science

Manufacturing Subcommittee

        

Gaithersburg Marriott - Washingtonian Center

9751 Washingtonian Boulevard

Gaithersburg, Maryland 20878

 

DRAFT Agenda                                                                                  May 21-22, 2003

 

8:30             Call to Order and Opening Remarks                            

 

                    Introduction of Committee

 

                    Conflict of Interest Statement                                                        

 

8:45             Introduction                                                                    

 

                       

Pharmaceutical cGMPs for the 21st  Century: a Risk-Based Approach

 

9:15             FDA Perspective                                                              

 

10:15            Break

 

10:30            Academic Perspective                                              

 

11:30            Open Public Hearing

 

12:30            Lunch

 

1:30             GPhA Pespective                                                             

 

                    PhRMA Perspective                                                        

 

2:30             Development of subcommittee work plan                        

 

                    Purpose and mission of subcommittee

                   

                    Questions to Subcommittee

 

                    Subcommittee Discussion

 

3:00             Break

 

4:30             Adjourn

 

Thursday, May 22, 2003

 

8:30      Call to Order and Opening Remarks                                           

 

            Introduction of Committee

 

            Conflict of Interest Statement                                    

 

 

Transition from Process Analytical Technologies (PAT) Subcommittee to

Manufacturing Subcommittee

 

8:40      Role of PAT in GMP Initiative                                               

 

Changes without prior approval - FDA perspective                             

 

10:00    Break

 

10:15    Perspective on risk analysis for the GMP Initiative                 

 

            Manufacturing and risk                                                          

 

11:30    Open Public Hearing

 

12:30    Lunch

 

Update - Regulatory approaches regarding aseptic manufacturing

 

1:30      Issues and future plans                                                

 

            PQRI Aspect                                                                           

 

2:30        Break

           

2:45      Subcommittee next steps                                                         

 

4:15      Conclusions and Summary Remarks                                     

 

4:30      Adjourn