Drug Products Stability and Shelf-Life

Course Objectives:

Stability is defined as the capacity of a drug substance or drug product to remain within established specifications to maintain its identity, strength, quality, and purity throughout the retest or expiration dating periods. Stability assessment of drug products and drug substances are mandated by regulatory agencies across the globe. In fact stability testing issues are responsible for a quarter of all audit findings by regulatory agencies. Stability testing problems also are regularly cited in warning letters and sometimes result in costly product recalls.

This one and half day course and workshop is designed to provide everything you need to know on how to design and implement a comprehensive and compliant stability program.

The workshop emphasizes practical issues such as:

• Development of stability protocols
• Use of bracketing in stability studies

The course provides ample opportunities for group discussions, case studies and exercises. It enables participants to gain the skills and knowledge necessary to meet the FDA, Health Canada’s and other regulatory agencies’ expectations.

A Two-day Comprehensive and Interactive Course with Workshop on:

• Critical Elements of Stability Program and Stability Testing
• FDA, Health Canada, WHO and ICH Guidelines; Q1A, Q1C, Q1D, Q1E, Q1F, Q2A, Q2B, Q3A and Q3B
• ICH Climate Zones
• Types of Stability Studies - Stability Study Designs
• Developmental Stability Studies (i.e., Phase 1 to 3)
• Consistency Studies for drug submission
• Validation Studies
• Routine Stability Studies (Marketed products)
• Setting-up Stability Program Policies, Procedures, SOPs and Study Protocols
• Preparation of Stability Reports
• Consideration in Developing Stability Indicating Methods
• Designing Reduced Testing Program: Bracketing & Matrixing
• Rational for Study Duration and Shelf-life Determination
• Testing Intervals; Long Term and accelerated
• Study Stability Batch Selection, Sample Size, and Sample Management
• Stability Chambers: Mapping, Qualification and Monitoring
• Study Tracking
• Stability Testing and Evaluation
• Stability Trending, Failure Investigation; OOS, and OOT
• Review of Recent Stability Related 483s
  

DISTINGUISHED COURSE LEADER

Mr. Ronald Turton

Chief Scientific Officer

QCL- Quality Compliance Laboratories

Mr. Turton has been involved within the Health Canada and FDA regulated pharmaceutical industries continuously since 1971. His experience covers the areas of Research and Development, Quality Assurance, Quality Control, Compliance, Technical Services and all aspects of Validation from a senior Management perspective. Currently, Mr. Turton is the Chief Scientific Officer at Quality Compliance Laboratories (QCL) providing a wide range of analytical testing services to the pharmaceutical, bio-pharmaceutical, nutraceutical and related industries. Mr. Turton was instrumental in implementing most of QCL's quality systems including the stability storage and testing program.

Prior to QCL, Mr. Turton was associated with Patheon for five years overseeing a team of people responsible for Stability, LIMS, Instrument Validation and Calibration, Technical Writing, Sampling and Packaging Material Control and Annual Product Review (APR). This team was critical to the attainment of committed goals as their internal and external customers included personel and functions extending beyond the laboratory.

Mr. Turton began his career as a bench analyst with Adam's Brands in Toronto. Within a year, he'd transferred to their pharmaceutical division (Warner Lambert) where he worked in various laboratory departments before leaving to join Sandoz Pharmaceuticals where he progressed through laboratory Supervisor to various Management roles with ever increasing responsibilities. When Sandoz merged with CIBA to become Novartis Pharmaceuticals, one of Mr. Turton's duties was to facilitate the transfer of more than 50 product lines into the Whitby manufacturing site from the Dorval manufacturing site while maintaining product Compliance with no major disruptions in product supply.

Mr. Turton is a member of the editorial board of "Pharmaceutical Canada", the only Canadian magazine devoted to providing information specifically targeting the pharmaceutical industry. As well, he is the current chairman of the Research Ethics Board (REB) of Lakeridge Health Corporation overseeing ethical approval of clinical trials conducted at several sites affiliated with Lakeridge Health.

Mr. Turton is also affiliated with a number of pharmaceutical organizations such as: the International Pharmaceutical Academy, the American Chemical Society, the Chemical Institute of Canada and the Association of the Chemical Profession of Ontario. He obtained his Master of Science degree in Chemistry from York University, Toronto and his Bachelor of Technology in Chemical Technology from Ryerson University, Toronto, Ontario.

Program Agenda

Program Content

Who should attend?

This one and half day course is valuable for associates, managers, as well as new stability team members in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

• Quality Assurance
• Quality Control
• R&D
• Analytical Laboratory
• Contract Laboratory
• Product Submission
• Validation
• Documentation and Technical Writing
• Regulatory Affairs
• Project Management
• Product Development
• Training
• Consultant
• Stability

Registration Information:

Certificate of Attendance: