OOS and Setting Specifications for Pharma, Biopharma and Combination Products

There can be many reasons for an OOS of a finished medicinal or combination product such as human error, laboratory error, material design, system, production or process or supply chain issues etc. which can be inevitable or out of our control. At a minimum we don’t want inappropriate specification settings to be the cause of OOS which we have some control.

This Training will also provide some guidance on a lifecycle approach to setting global specifications for pharmaceutical, biological and biotechnology-derived products.
In the biopharmaceutical industry, specifications are legally binding criteria that a product must meet in order to be marketed. They ensure the consistency and quality of the product and help ensure that it is safe and efficacious over the shelf life of the
product. Specifications evolve during product development and ideally should embrace future process capability.

This is true for biological and biotechnology-derived products for which there may be limited experience at the time of regulatory filings (including the marketing application), and for which early commercial production often is necessary to gain a better understanding of product quality attributes, methods, and limits.

Why You Should 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 Product Development, QA, QC and Regulatory professionals you will learn in what to look for in setting specifications for Drug Substance or Active Pharmaceutical Ingredients (API), 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.

This webinar will provide an overview of setting and maintaining specifications for Pharmaceutical and Biotechnology derived drug products throughout its 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


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.

FYS assists companies to achieve results by collecting client’s training requirements, custom designing, developing, and delivering training for employee to improve patient outcomes. Tanvir designs, develops, and delivers training in Risk Management, cGMP and other customized training for Pharma, Biopharma and Medical Device Industries.

Tanvir is a member of the Toastmasters International Club and Project Management Institute. Awards include Certificate of Achievement for presenting the topic Quality Risk Management for Pharma/Biopharma and Medical Device at the NEQC 59th, 60th, 61st and 62nd Conference. Oct 2012, Oct 2014, Oct 2016 and Oct 2018 Advanced Communicator Bronze (ACB), TOASTMASTERS INTERNATIONAL, May 2018.

  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT

  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance