Components of a Compliant Stability Program

Venue: International Plaza Hotel & Conference Centre

Location: Toronto, Ontario, Canada

Event Date/Time: Feb 21, 2005 End Date/Time: Feb 22, 2005
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Description

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
- Requirements for ICH Stability (Q1A-F)
- Setting up limits and specification
- Determination of Stability Indicating Methods
- Reduce Stability Testing (Bracketing & Matrixing)
- Developing global stability protocols
- Clinical Product Stability
- Current issues on Stability such as Zone III/IV conditions
- Handling Stability OOS/OOT results
- User Requirements for 21 CFR part 11 Stability Software

WORKSHOPS & CASE STUDIES:
- Stability Protocol preparation
- Creating a Bracketing design
- Creating a Matrixing design
- Investigating Stability OOS test results
- Review and discussion around stability related FDA 483's (Group)

Once again in pursuit of excellence, the International Pharmaceutical Academy (IPA) is proud to bring you the 4th Annual Pharmaceutical Stability event, "Components of a Compliant Stability Program".

Performing stability testing program is not a small task and can take as long as five years or more. In addition there is substantial financial investment in running such a long-term study. Mishandling of a study could be very costly in both money and time, and a single delay can cost the company millions of dollars. Stability and stability-related issues have been the prominent cause of drug product recalls in the past years. When implementing stability program, you must have a secure, controlled environment that will maintain sample integrity and have adequate laboratory procedures that provide training, qualified instrumentation, validated methods and controlled documentation. In addition the quality assurance unit must have intact systems. Above all, it must be assured that the testing laboratory can execute stability testing in a timely fashion and in line with many complex regulatory requirements such as ICH and FDA guidelines.

The objective of this year's program is to present specific information on how to achieve efficiencies in establishing a compliant stability program and related new regulatory processes. This course clarifies FDA regulatory requirements and ICH guidelines as applied in designing stability programs from the early stages of product development all the way to approval and post approval changes. Among the topics to be addressed will be: identifying FDA’s regulations and ICH guidelines for stability testing, writing study protocols and reports, designing stability indicating analytical test methods, establishing effective Stability Data Management Systems, conducting and documenting OOS results and deviations.

As an institute for providing quality training and skills development programs, IPA is proud to bring together expert presenters from across the borders to exchange their views and in-depth knowledge of the most important issues in stability testing today.

This program will address a broad range of stability issues and will provide numerous case studies and workshops to ensure a practical and useful learning experience.

The program has been designed to ensure topics are explored in detail and includes ample opportunities for interaction between and among delegates and presenters.







Strategies on how to Design and Implement a Comprehensive Stability Program Ensuring
Regulatory Compliance & Best Practices in GMP



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Forum Speakers
Who Should Attend?
Hotel & Seminar Location: Program Agenda
Seminar Registration Fee
Methods of payment
Online Register



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
Requirements for
ICH Stability (Q1A-F)
Setting up limits and specification
Determination of Stability Indicating Methods
Reduce Stability Testing (Bracketing & Matrixing)
Developing global stability protocols
Clinical Product Stability
Current issues on Stability such as Zone III/IV conditions
Handling Stability OOS/OOT results
User Requirements for 21 CFR part 11 Stability Software
WORKSHOPS & CASE STUDIES:

Stability Protocol preparation
Creating a Bracketing design
Creating a Matrixing design
Investigating Stability OOS test results
Review and discussion around stability related FDA 483's (Group)

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Distinguished Faculty

Dr. Nicholas F. Cappuccino
Dr. Cappuccino is presently the Vice-President of Scientific Affairs and a member of the Executive Management Committee for Sandoz Inc. in Princeton, NJ. Prior to joining Sandoz in 2002, he was Vice-President of R&D for Apotex, Inc., Toronto, Canada, responsible for world-wide generic drug development at Apotex. Before joining Apotex Dr. Cappuccino worked once before for Sandoz at Geneva Pharmaceuticals in Broomfield, CO as Director of Analytical R&D. Prior to that he was associated with Hoechst-Roussel Pharmaceuticals, Bridgewater, NJ where he held positions of increasing responsibility including Senior Analytical Chemist, Research Associate and Manager of Analytical Research. While completing his Ph.D. in Organic Chemistry from Stevens Institute of Technology, Dr. Cappuccino worked for several years in the Research Division of Schering-Plough Corporation, Bloomfield, N. J.
Dr. Cappuccino currently serves as the Chair of the Science Committee for the International Generic Pharmaceutical Alliance (IGPA) and represents the generic industry as an Observer on the ICH Steering Committee and as an Industry Expert on the WHO Expert Committee for Pharmaceutical Preparations. Nick has been a member of the ICH Expert Working Groups for Stability (Q1A-F) and Impurities (Q3A/3B). He is a member of the AAPS, DIA, and ACS.

Dr. Anthony Mazzeo
Dr. Mazzeo began his career with DuPont’s Petrochemical Division in 1980 after receiving a B.Sc. in Chemistry from S.U.N.Y at Brockport. After several years with DuPont he left to attend graduate school at Syracuse University where he received a Ph.D. in Analytical Chemistry in 1991 under professor George Levy. He has served as manager of technical support and Quality Assurance at New Methods Research Inc. in Syracuse, NY. In 1993 he joined Bayer Corporation’s Allergy Products Division in Spokane, Washington where he was a Quality Assurance Scientist, a position which later included the stability program responsibilities. In 2000, he accepted the position of R&D Stability Manager at DuPont Pharmaceuticals Company in Wilmington, DE (now part of Bristol Myers-Squibb). At DuPont Pharma he was a member of the R&D Stability Review Board. He joined Pfizer Global Research and Development at Pfizer’s Michigan Laboratories in February 2002 to head up the Stability and Outsourcing Group in the Pharmaceutical Sciences Analytical R&D department where he has been involved in harmonizing stability practices throughout all Pfizer R&D sites.
He is a member of AAPS and the American Chemical Society for which he has held each of the officer positions at the Inland Northwest Local Section, including section chair in 1998 and 2000. He is a member of the PhRMA Stability Expert Team and currently involved on the PQRI ad hoc committee on RFIDs and Product Quality.

Mr. Wilhelm Leung
Mr. Leung is the Director of Quality at Cardiome Pharma, Vancouver – Canada with over 30 years experience in the pharmaceutical industry. Prior to joining the Cardiome Pharma, Mr. Leung held the position of Director of Quality and Stability at QLT Inc. In the past Mr. Leung has served many well-known pharmaceutical companies such as Novopharm, Apotex Inc. and Genpharm, and has held numerous senior positions within Bioanalytical, Analytical Research and Development, Stability and QC departments. Mr. Leung expertise include; strong understanding of global regulatory requirements for Pharmaceuticals (FDA, HPB/TPD, ICH) and their practical application in a rapidly changing operations environment, technology transfer and project management, development of specifications and characterization of pharmaceutical products and design and implementation of stability programs. Mr. Leung received his degree in Pharmaceutical Analysis from University of Manchester in United Kingdom.

It may be necessary, for reasons beyond our control, to alter the identity of the speakers


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Who Should Attend?
Because of its comprehensive content, this course will be most valuable to 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

Venue

655 Dixon Road
Toronto
Ontario
Canada
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Additional Information

Certificate of Attendance: All participants will receive a certificate of attendance upon completion of the course Registration Fee Includes: Presentation Materials, Luncheon, Refreshments and Parking