Sterile Product Assurance - Building a Data Package that Convinces Agencies your Product is Good

Instructor: Peter Calcott
Product ID: 702110
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

This Sterile Product Assurance Webinar training will discuss the bases for the claim that your product is sterile after aseptic processing. It will demonstrate the multilayered levels of assurance that together create the assurance needed to claim sterility and how any one of them can result in regulatory issues which can cause severe effects to your position.

Course "Sterile Product Assurance – Building a Data Package that Convinces Agencies your Product is Good" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

This webinar will provide you the foundation for building a case for the sterility assurance of your parenteral product whether clinical or commercial. It will include those elements that are defined even before you make the first batch including facility and equipment design and selection, set up and validations, qualifications and process simulations. It will help you to develop standards for your operations, how to monitor to assure you meet those standards, before, during and afterwards, and to assure that operators meet their qualification criteria.

You will also learn how other companies fail to deliver a convincing sterility assurance package to the agency. With this information you will be able to determine whether your processes and data packages are sufficient to convince the agency.

Areas Covered in the Seminar:

  • Why sterility assurance is important to parenteral products and why the sterility test is just not enough.
  • The linkage between and interdependencies of the various elements in building the case for a sterile product.
  • The role facility, equipment, layout and adjacency play in assuring sterility.
  • About the validation, process qualifications and simulations and operator training and qualification that play a crucial role in assuring sterility.
  • The standards and monitoring needed, as well as the testing, that are required to assure the success of your operations.
  • The way other companies fail to deliver on the agency expectations and how to avoid the pitfalls.

Who Will Benefit:

This Webinar is useful for all companies in pharmaceutical and biotech industries that manufacture sterile products using aseptic processes. All staff from following department must attend this course:

  • Quality Assurance
  • Quality Control
  • Regulatory Compliance
  • Regulatory Affairs
  • Manufacturing
  • Validation
  • Supply Chain and Logistics
  • Project Managers working in the CMC arena
  • Senior Management and executives

Instructor Profile:

Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, pharma and venture capital industry. It provides consulting services in supply chain, quality systems, clinical development, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.

He has held positions in industry in all these disciplines over a 30 year career. He has presented at national meetings and is active in the biotechnology community via BIO and the bay area BayBio trade associations where he was chairman of the BIO RAC committee and is currently a Board member of BayBio.

Topic Background:

Most biological, biotechnological and many pharmaceutical products are administered parenterally and therefore must be produced sterile. Since many of these products are heat labile, including biologicals and biotechnology products, they cannot be terminally sterilized in their final container but are rather aseptically processed. To assure the sterility of the final product requires a complex set of interrelated activities and studies prior to manufacture as well as tight controls and testing both during and after the operations. Although aseptically processed sterile products have been on the market for decades, companies still fail to deliver on the assurance to the satisfaction of the various regulatory agencies. However, by understanding the various elements and how they contribute to the assurance, you can develop a package that not only convinces you but also the agency.

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