DESIGN & IMPLEMENTATION OF EFFECTIVE STABILITY PROGRAM

Venue: DoubleTree International Plaza Hotel & Conference Center

Location: Toronto, Ontario, Canada

Event Date/Time: Feb 20, 2006 End Date/Time: Feb 21, 2006
Early Registration Date: Jan 15, 2006
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Description

DESIGN & IMPLEMENTATION OF EFFECTIVE STABILITY PROGRAM

A TWO-DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOPS ON:

- Essential elements of a compliant stability program
- ICH and FDA requirements for Drug Substances and Drug Products
- Structuring requirements around ICH guidelines
- Validation of Stability Indicating Analytical Test Methods
- Setting up limits and specification
- Method Verification for Stability Indicating Test Methods
- Method Transfer Requirements for Stability Indicating Test Methods
- Sample Handling and Tracking Systems
- Reduce Stability Testing (Bracketing & Matrixing)
- Developing global stability protocols
- Evaluation of data from stability studies
- Qualification and Maintenance of Stability Storage Chambers
- Current issues on Stability such as Zone III/IV conditions
- Handling Stability OOS/OOT results

WORKSHOP & CASE STUDIES

Handling Stability OOS and OOT Results

This session will review the guidance documents applicable to OOS results. One method of using laboratory investigations data for improving existing processes will be discussed. Trending Investigation Report data can lead to identification of potential improvements in analytical methods. Trending can also lead to identification of error prone processes that lead to analyst errors.
This workshop utilizes case study and encourages audience participation. Topics covered include:

Recent warning letters will be reviewed to identify and highlight common pitfalls in handling OOS and OOT test results. The attendees will perform an in-depth review of some of the warning letters to identify OOS SOP steps and CAPAs to prevent the occurrence of the identified issues.

Preliminary Investigation
- Identifying and assessing OOS test results
- Preliminary evaluation exercise
- Roles, responsibilities, conclusions and documentation
Stage I Investigations and Expanded Stage II Investigations
- Laboratory investigations process
- Roles, responsibilities, conclusions and documentation
Corrective and Preventive Actions (CAPA)
- Root Causes Analysis
- Conclusions and documentation
- Action, follow up and documentation
Preventing OOS/OOT Occurrences

Distinguish Program Facilitators:

Tonino Antonetti - Health Canada

Dr. Nicholas F. Cappuccino - Andrx Pharmaceuticals

Dr. Geoff Carr - Patheon Inc.

Dr. Chris Knutsen - Strides Inc

Dr. Paul Newton - GlaxoSmithKline

Dr. Nanda Subbarao - Sandoz

Who Should Attend?

This 2-day course and workshops is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Vitamin, Herbal, and allied industries with daily responsibilities in the following areas:

- Stability
- Quality Control
- Analytical R&D
- Raw Materials Testing
- Product Development
- Formulation
- Chemistry, Manufacturing and Controls (CMC)
- Quality Assurance
- GMP/GLP Compliance
- Pre-Clinical Research
- Regulatory Affairs
- Validation
- Product Submission
- Training
- Documentation and Technical Writing
- Contract Laboratories
- Consultants
- Contract manufacturing
- and other Compliance professionals

Venue

Additional Information

*Multiple Registrations: Send five attendees and the sixth is FREE!

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