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Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

ComplianceOnline

Thursday, June 29, 2017 at 8:30 AM - Friday, June 30, 2017 at 4:30 PM (CEST)

Raw Material Requirements (Health Canada/USP/EP) in a...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (USD) (early bird price)
For Registrations after June 5, 2017 - $2299
Jun 29, 2017 $1,899.00 $0.00
Seminar One Registration (USD) Jun 29, 2017 $2,299.00 $0.00

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Event Details

Raw material requirements in a cGMP environment are often overlooked as a company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion.

This highly interactive two day seminar on raw material requirements in a cGMP environment will:

  • Consider Health Canada, FDA, USP and EP requirements.
  • Examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2, 3 and commercial production.
  • Cover testing requirements during each phase and what may be optional (regulatory risk) until the product moves to its next phase.
  • Determine what options exist - even within a Phase 2 or Phase 3 testing framework.
  • Discuss compendial vs. non-compendial testing and how to respond when no method is available.
  • Discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing.
  • Explore the number of lots required for testing before reduced testing might occur and why some companies don't accept this route.
  • Review the use of individual samples vs. composite samples for testing.
  • Explore ASQ testing to include how to choose attributes and sample size.

The objective of this two day seminar is to explore raw materials and their requirements – issues and solutions. It will also explore how water impacts the final product since water is the single largest raw material that is used within most processes. Another objective is to assure that your organization is maintaining itself within a cGMP compliance framework. Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.

Learning Objectives:

Upon completing this course on raw material requirements in a cGMP environment participants will:

  • Understand how various types of raw materials may impact the user.
  • Learn of the impact of raw materials in the timely production of a product.
  • Determine the single most used raw material in large molecule production and what it means to the user.
  • Find the sources of analyses assistance for raw materials.
  • Appreciate the requirements for Phase 1 through commercial manufacturing.
  • Initiation of additional testing -- when?
  • Examination of regulatory risk (ICH Q9).
  • Why use compendial testing in lieu non-compendial testing.
  • Testing requirements -- when is enough?
  • The impact of ASQ on sample size and attribute testing.

 

Who Will Benefit:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality Control
  • Microbiology
  • Document control specialists
  • R & D

 

For Registrationhttp://www.complianceonline.com/raw-material-requirements-health-canada-usp-ep-in-a-cgmp-environment-issues-and-solutions-seminar-training-80439SEM-prdsm?channel=eventbrite           

 

Note: Use coupon code  NB5SQH8N  and get 10% off on registration.

Have questions about Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions? Contact ComplianceOnline

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When & Where


Vienna

Vienna
Austria

Thursday, June 29, 2017 at 8:30 AM - Friday, June 30, 2017 at 4:30 PM (CEST)


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Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
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