Specification and OOS for Pharma, Biopharma and Combination Products

Why Should You Attend:

Stericycle Expert Solutions in their Q1 2019 Recall Index indicates, For the Eleventh consecutive quarter, failed specifications were the top reason for pharmaceutical recalls.

For example, in this webinar, as a QA, Product Development, QC and Regulatory professional you will learn about what to look for in setting specifications for Drug Substance or Active Pharmaceutical Ingredients, Starting materials, Raw materials, Excipients and Final Product of small and or Biotechnology derived drug products.

The overall goal of this course is to raise awareness for setting the right specifications for the drug product to improve patient satisfactions and to prepare organizations for regulatory inspections. The session provides quality assurance and product development professionals with a management perspective to make the right decisions in selecting the correct specifications.

Emphasis is on higher level on how to prevent OOS, product recall, FDA and or other regulatory notifications due to specification failures, Patient Safety and Satisfaction.

Learning Objectives:

Understand the principles of Specification Settings:

• 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

Areas Covered in the Webinar:

Overview of following in preparation of understanding setting specifications:

• CQA and Quality Attribute
• CPP and Control limits
• OOS, OOT and OOE
• 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 Will Benefit:

This training discussion seminar has been designed for quality assurance, quality control, regulatory affairs and Product development (Formulation and Analytical) personnel in the Pharmaceutical and Bio-pharmaceutical Industries.

It also addresses staff from other departments too, in so far as they are subject to EU and FDA GMP compliance.

• Product development (Formulation and Analytical)
• Production
• Engineering
• Quality Assurance
• Quality control
• Marketing and Sales
• Regulatory affairs
• Supply Chain

Tanvir Mahmud
Founder and Principal, Find Your Solution

Tanvir Mahmud has more than 20 years’ experience in product development, quality and project management in regulated industries including Biogen Idec, Vertex Pharmaceuticals, Boston Scientific, and Consulting Companies. She has a master’s degree in Physical and Biochemistry and a master certification in coaching. Her professional experience relates to research and development, analytical development, formulation development, quality management, chemistry manufacturing and control, drug/device/biologics/combination product stability, training and program management.

Tanvir is a consultant and a trainer at QPS and a Founder and Principal at Find Your Solution (FYS) Consulting and Training, a company offering training and consulting in Risk Management and Continuous Quality improvement.

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