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Four separate Discussion Groups to a single forum covering
all 4 topics.
 Pharmacopeial Issues
Pharmaceutical Analysis - HPLC and Dissolution
Process Analytical Technology (PAT)
Equipment Qualification/Verification
The objectives for the combined Discussion Group
are to:
Provide a forum for free exchange of scientific
information
Solicit feedback on best practices
2008:
Discussion Group Sessions (October 10)
Session 1: Analytical
Sciences
Chair: Dr. Herman Lam
- TeraHertz Spectroscopy Mr.
Mark Kemper (Picometrix LLC)
- Calibration of NIR
Spectrophotometers Dr. Herman Lam Wild Crane
Horizon
- Sub 2um Particles for
Reverse Phase Chromatography: Benefits, Concerns
and a Guide to Column Selection Dr. Christine Hand
Waters
- Mechanical calibration for
dissolution apparatus Ms. Julie Clucas
Varians
Session 2: Pharmaceutical
Quality and Regulatory Round Table Discussion Chair:
Elaine Vandenberg, Ph.D., GlaxoSmithKline Canada Inc.
- Case studies in product
characterization Ms. Stephanie Croft BPS, TPD
- A Discussion on USP Hot
Topics Debrah Cobham QA Manager GSK
- Round Table discussion Dr.
Chris Watts FDA and Dr. Kahkashan Zaidi USP
2007
Discussion group information
Meeting Details and Discount:
Sign up for 2 discussion group
meetings and the CVG/TPD Annual International Convention
for one discounted registration fee! The meetings
will be held as follows:
| Date |
Venue |
Function |
 |
| April 13 2007 |
Purdue
Pharma |
Discussion Group |
|
June 22 2007 |
PharmLink
Innovations |
Discussion Group |
|
| October 4-5 2007 |
DoubleTree Airport |
International Convention & Discussion Group
|
|
CVG
Discussion Group meeting -
June 22, 9am to 4pm, at PharmEng Innovations
Agenda:
|
|
Topics
|
|
9:15 am to 10:00 am
|
USP
Update
|
|
10:00 am to 10:45 am
|
UPLC
Analysis
|
|
10:45 am to 11:00 am
|
Break
|
|
11:00 am to 11:45 am
|
Dissolution
Automation ¡V a case study
|
|
11:45 am
to 12:30 pm
|
Automated
HPLC method validation
|
|
12:30 pm to 1:00 pm
|
Lunch
|
|
1:00 pm to 1:45 pm
|
Implementation
of the
Corona
CAD in Analytical Development and
Manufacturing Operational
|
|
1:45 pm to 2:30 pm
|
A-QPIC
|
|
2:30 pm to 2:45 pm
|
Break
|
|
2:45 pm to 3:30 pm
|
Classification
and Regulatory Approval of Medical Devices
|
|
3:30 pm to 4:15 pm
|
Automated
Dissolution System Validation
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CVG
Discussion Group meeting -
April 13, 9am to 4pm, at Purdue Pharma
Agenda:
|
|
Topics
|
|
9:15 am to 10:00 am
|
USP
Update
(click to see the presentation)
|
|
10:00 am to 10:45 am
|
CE
Method Development
|
|
10:45 am to 11:00 am
|
Break
|
|
11:00 am to 11:45 am
|
USP
4 Dissolution for suspension
|
|
11:45 am
to 12:30 pm
|
Sterility
validation on parental product
|
|
12:30 pm to 1:00 pm
|
Lunch
|
|
1:00 pm to 1:45 pm
|
PAT
Playground
|
|
1:45 pm to 2:30 pm
|
Raman applications in PAT
|
|
2:30 pm to 2:45 pm
|
Break
|
|
2:45 pm to 3:30 pm
|
NIR
for raw materials ID
|
|
3:30 pm to 4:15 pm
|
Quality
by Design - A Roadmap for Success
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How to register?
The
annual membership fee for each discussion group
is $600 and an additional $30 for CVG membership. This
will entitle the member for all of the three meetings
(breakfast, lunch and refreshments included) of the
discussion group. You will become a regular CVG
member
and enjoy all the rights and privileges of CVG membership.
Information on other CVG activities can be found
at
www.cvg.ca
The membership is transferable within the same company,
but not refundable.
If you have any questions about the individual discussion
topics, please feel free to contact:
Dr. Herman Lam, Ph.D.
(905-819-7131)
Potential discussion topics
Listed below are potential topics for the coming
discussion group meetings. Please send other topics
of interest to Chung Chow Chan for potential inclusion
in forthcoming meetings.
Pharmacopeial/RegulatoryTopics
1. Q7A Guidance from TPD
2. Excipient Regulatory Requirement ?Non-animal source
3. Excursion study requirements ?HPFBI Guidance
4. Setting specifications for drug substance and drug
product
5. System suitability: What parameters and how to
set up?
6. USP Pharmacopeial Forum: A New General Information
Chapter on Dissolution
PAT and New Technologies Topics
1. PAT applications and implementation
2. Advanced spectroscopic techniques
3. Chemical imaging techniques
4. Automation
Pharm AnalysisTopics
1. Column Equivalence and Orthogonality, PQRI vs
USP approach. Case studies.
2. Analysis of low dose/highly potent compounds. What
technology is available?
3. USP Apparatus 3-7: Shared learning from USP and
industry on application of these apparatus
4. Cleaning validation
5. Setting acceptance criteria for dissolution
6. Dissolution method development for extended release
formulations
7. KF method validation: LOD vs titration vs other
techniques.
8. KF method development: issues with hygroscopic
compounds and high starch formulations.
9. Advances in dissolution technologies and applications
Equipment Calibration Topics
1. Lab equipment qualification and management ?Sharing
best practices
2. USP Apparatus 1-7: qualification and calibration
3. Data back up and achieve
4. 21 CFR Part 11 ERES update
5. Equipment for particle size measurement
6. Equipment for thermal analyses
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