GMP Roundtable

Conference

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2003 Roundtable Conference Information:

Date of This Year's Event: October 21st and 22nd, 2003

This year's company sponsor is : Pfizer

Hotel Link: Dearborn Hyatt Regency

Hotel Map Link: Map & Directions

This year's Agenda:

13th Annual GMP Roundtable

October 21st – 22nd, 2003

       Monday, October 20

    5:00 – 7:00 p.m.  Registration (The Hyatt Regency)

    7:00 – 9:00 p.m. Steering Committee Dinner

 

      Tuesday, October 21

    7:30 – 8:30 a.m.  Registration & Continental Breakfast

                          (The Desoto Room)

    8:30 – 8:45 a.m. Welcome

 8:45 – 10:00 a.m. Speaker:  David Bernstein, CATO Research

                        Topic: FDA’s Risk-Based GMP Initiative -                    

                              Impact on Investigational Drug Products During                                    Development

           10:00 – 10:30 a.m.           Break

           10:00 – 12:00 p.m.       Breakout Sessions I

A.                 Clinical Supplies: Drug Product –

                                                                        GMP Requirements by Phase

                                              B.  Technology Transfer & Change Control

C.    Drug Substances GMPs by Phase]

D.    Worldwide Distribution of Clinical Supply                 

12:00 – 1:00 p.m.    Lunch

    1:00 – 2:30 p.m. Breakout Session II

A.     Supply Chain Automation

B.     Radiolabeled Chemcials, Biotracers, PET Drugs, Microdosing

C.    Lab Computer & Equipment Validation

D.    Annex 13 Changes

    2:30 – 3:00 p.m.    Break

    3:00 – 4:30 p.m. Breakout Session III

A.     Early Phase Clinical Supplies Compounding,

Good Pharmacy Practice & GMPs

B.     Process Analytical Technology PAT

C.    Establishing Specifications

D.    Room Classification & EM (Dry Products,

Non-Sterile API)

   5:00 – 7:00 p.m.     Reception (Desoto Foyer)

 

Wednesday, October 22

   7:00 – 8:00 a.m.    Continental Breakfast (The Desoto Room)

    8:00 – 9:30 a.m. Breakout Session IV

A.     Parenteral Dosage Forms Manufacturing

B.     GMP vs. non-GMP Requirements in R&D Phase

C.    CAPA Deviations/OOS

D.    Quality Unit (QA) Responsibilities

 9:30 – 10:00 a.m.    Break

           10:00 – 11:30 a.m.       Breakout Session V

A.     Biotechnology Issues

B.     Electronic Records; Electronic Signatures

(Part 11 Rule)

C.    Stability Program

D.    Third Party/Suppliers Management     

           11:30 – 11:45 a.m.          Closing Remarks – Pfizer, Inc.

      11:45 a.m.            Lunch

         1:00 p.m.            Close