OOS and Setting Specifications for Pharma, Biopharma and Combination Products

Unravel the intricate tapestry of out-of-specifications (OOS) in finished medicinal or combination products, a puzzle with manifold origins such as human error, laboratory glitches, material design quirks, system intricacies, and the labyrinth of production, process, or supply chain challenges. Some of these elements might be beyond our grasp, falling into the realm of inevitability or factors beyond our immediate control. At the very least, we aim to eliminate inappropriate specification settings as a contributor to OOS, a realm where we hold some sway.

This training venture extends beyond the mere unraveling of OOS mysteries. It serves as a beacon, guiding you through the labyrinth of a lifecycle approach to establish global specifications for pharmaceutical, biological, and biotechnology-derived products. In the biopharmaceutical arena, specifications aren't mere suggestions; they are legally binding benchmarks dictating a product's eligibility for market presence. These criteria stand as guardians, ensuring product consistency, quality, safety, and efficacy throughout its shelf life, evolving dynamically during product development and striving to embrace future process capabilities.

Why You Should Attend:

Join us in this webinar, an immersive experience tailored for Product Development, QA, QC, and Regulatory professionals. Dive deep into the art of setting specifications for Drug Substance or Active Pharmaceutical Ingredients (API), Starting materials, Raw materials, Excipients, and the Final Product of small and Biotechnology-derived drug products. The journey aims not only to equip you with the knowledge to navigate recall pitfalls but also to elevate your awareness and decision-making prowess in selecting the right specifications for drug products, ultimately enhancing patient satisfaction and preparing organizations for the scrutiny of regulatory inspections. This session is your compass in the nuanced landscape of setting and maintaining specifications for Pharmaceutical and Biotechnology-derived drug products, ensuring their integrity throughout the intriguing journey of shelf life.

Areas Covered in the Session :

• Define Terminology: CQA, CPP, OOS, OOT, OOE, Quality Attribute, Control limits, Specifications, Release vs Shelf-Life Specifications
• Specification settings based on Early-Stage Development or preclinical data
• Specification settings based on preclinical and clinical data
• Lifecycle approach to setting global specifications
• Establishing Patient Centric Specifications for Drug Substance and Drug
• Product Impurities

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Product Development Teams (Formulation and Analytical)
• Marketing Departments
• Documentation Departments
• Supply Chain Departments

Course Director: KELLY THOMAS

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.