Joint CVG/Therapeutic
Products Directorate (TPD)
2005 INTERNATIONAL CONVENTION AND EXHIBITIONS
"Risk-Based Decision Making in Pharmaceutical
Validation"
October 6-7, 2005 (Toronto,
Ontario, Canada)
Double Tree International Plaza Hotel, 655 Dixon Road, Toronto
Tel: 416-244-1711, www.internationalplaza.com
This convention will be conducted in English.
|
 |
October 6, 2005 - Plenary
Session
|
|
| Introduction and Start of Programme |
Chung Chow Chan, Ph.D. |
8:40AM - 8:45AM |
|
| Opening Remarks |
Herman Lam, Ph.D.
CVG
|
8:45AM - 8:50PM |
|
Key Note Address:
How to Survive and Thrive as
Scientist in the 21st Century |
Brian Fahie, Ph.D.
Eli Lilly & Company
|
8:50AM - 9:35AM |
|
| PAT Update |
FDA invited |
9:35AM - 10:20AM |
|
| Morning Break |
|
10:20AM - 10:50AM |
|
| Cleaning Validation: What is Expected? |
Tonino Antonetti
HPFBI, Health Canada |
10:50AM - 11:25AM |
|
| Validation Requirements for Shipping Studies |
Speaker to be confirmed USP |
11:25AM - 12:00PM |
|
| Lunch Break |
|
12:00PM - 2:00PM |
|
| Applications of Stratified Sampling in Process Validation |
Paul Stojanovski
Patheon |
2:00PM - 2:35PM |
|
| Impact of PAT on Excipient Qualification |
David Schoneker
Colorcon Inc. |
2:35PM - 3:10PM |
|
| Break |
|
3:10PM - 3:40PM |
|
| Compendial Information in Regulatory Filings - Risk-Based
Approach |
Barbara Ferguson
Schering Plough |
3:40PM - 4:15PM |
|
| Validation of Electronic Systems in the Lab |
Wilson Wong
GlaxoSmithKline |
4:15PM - 4:50PM |
|
| Wrap Up for the Day and Door Prizes |
Chung Chow Chan/
Elaine Vanderberg
|
4:50PM - 5:15PM |
|
| |
| October 7, 2005: Discussion
Group Sessions |
|
| Breakfast |
|
8:30AM - 9:00AM |
|
| Round Table Parallel Discussion Sessions |
|
9:00AM - 12:15PM |
|
| |
Round Table Parallel Discussion
Sessions (9:00AM-12:15PM)
Session 1: Pharmacopoeial
Chair: Dean Callaghan,
AstraZeneca |
|
| Acceptable Methods |
|
Alison Ingham, TPD |
|
| Impact of FDA Regulations and CTD Guidance
on Compendial Information in Regulatory Filings |
Barbara Ferguson
Schering Plough |
|
| Packaging Requirements for Solid Oral
Dosage Formulation and Oral Liquid Formulation |
Speaker to be confirmed
USP |
|
| Revised GMP Guidance on Terminal Sterilisation
Process Validation |
Tonino Antonetti
HPFBI |
|
Session 2: Pharmaceutical
Analysis: HPLC Separation and Dissolution
Chair: Dennis Xia,
Apotex |
|
| Test Requirement for Nasal Spray |
Anita Hui
Apotex Richmond Hill |
|
| Shipping Studies in Relation to Labelling |
YC Lee
PharmLink |
|
| Validation of Particle Size in API and
Excipient |
Mark Bumiller Malvern Instrument |
|
| Column Classification |
|
Chung Chow Chan
Eli Lilly & Company |
|
Session 3: Process Analytical
Technology
Chair: David Mayers,
Purdue Pharma Canada |
|
| End Point Determination for PAT |
Stephen Closs
Patheon |
|
| The Role of Raman in PAT Applications |
Mark Kemper
Kaiser Optical Systems |
|
Impact of PAT on Excipient Qualification
- Additional discussion |
David Schoneker
Colorcon Inc |
|
| DOE Application to PAT |
John McCluskey
Pharmeng |
|
Session 4: Process Validation
Chair: Alan Kwong/Ravi
Joshi, PharmEng Technology Inc. |
|
Challenge Studies for Tablets - A Prelude
to
Process Validation |
Krishnan Tirunellai
TPD |
|
| Process Validation for Liquid Product |
Atif Zia
Apotex |
|
| Cleaning Validation |
|
Le Vu
Purdue Pharma Canada |
|
Current Solutions for Potent Powder
Containment
for R & D Laboratories, Scale-Up and Production
Facilities |
Steve Janz
Flow Sciences Inc. |
|
