2-Day Raw Material Requirements (Health Canada/USP/EP) in cGMP Environmental Problems and Solutions Training Course (September 15-16, 2022) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The course “Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment – Issues and Solutions Training Course” has been added to from ResearchAndMarkets.com offer.

The objective of this highly interactive FIVE HOUR/DAY, two-day WCS seminar is to explore raw materials and their requirements – problems and solutions.

It will also explore the impact of water on the final product, as water is the most important raw material used in most processes. Another goal is to ensure your organization maintains a cGMP compliance framework to include ICH Q7, Q9 and Q11. Case studies, including warning letters, will be discussed to illustrate commodity regulatory issues.

Raw material requirements in a cGMP environment are often overlooked when a company is developing new products. Depending on the product being developed, for example, tablets and capsules versus biotech products to include recombinant microorganisms and gene therapy products, one needs to find as few as fifteen to twenty or as many as sixty materials first before the process can be moved from initiation to completion.

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

  • Compare and contrast FDA, Health Canada, ICH, USP and EP requirements

  • Review the latest updates to include FDA, Health Canada, ICH, USP, and EP requirements

  • Examine a variety of raw material issues to include which materials need to be tested and to what extent during Phases 1, 2, 3 and commercial production.

  • Cover testing requirements during each phase (appropriate phase), to include microbes and endotoxins, and what may be optional (regulatory risk) until the product moves to its next phase.

  • Determine what options exist – even in a phase 2 or phase 3 testing framework.

  • Discuss compendial and non-compendial tests and how to respond when no method is available.

  • Explain how a minimum purity analysis of 90% versus 90.0% may delay the start of testing.

  • Learn how many batches are required for testing before reduced testing occurs and why some companies aren’t going this route.

  • Review the use of individual samples versus composite samples for testing.

  • Review packaging and storage requirements and their impact on incoming materials to include both raw materials and API.

  • Explore ASQ tests to understand how to choose attributes and sample size.

  • Determine when ASQ relative to the square root of N+1 is appropriate.

Learning objectives:

At the end of this course on raw material requirements in a cGMP environment, participants:

  • Understand how various types of raw materials can impact the user.

  • Discover the impact of raw materials to include any bacteria and endotoxin issues in the timely production of a product.

  • Determine the feedstock most used in the production of large molecules and what it means to the user.

  • Find sources of help with raw material analyses.

  • Appreciate the requirements from phase 1 to commercial manufacture – why safety is required in phase 1

  • Start of additional testing — when?

  • Regulatory risk review to include ICH Q7, Q9 and Q11.

  • Why use compendial tests rather than lay tests.

  • Testing requirements – when is it enough?

  • Understand packaging and storage requirements and their impact on incoming materials to include both raw materials and API.

  • The impact of ASQ versus the square root of N+1 on sample size and attribute testing.

Who should attend:

Those who will benefit from this ONLINE seminar include:

  • Quality professionals

  • Regulatory Professionals

  • Compliance professionals

  • Manufacturing engineers

  • Quality engineers

  • Quality auditors

  • Quality control

  • Microbiology

  • Incoming materials

  • Document control specialists

  • R&D

  • Project managers

Main topics covered:

DAY 01 (10:00 a.m. – 4:00 p.m. EST)

10:00 a.m.: Beginning of the session

  • Compare and compare FDA, Health Canada, ICH, USP and EP requirements.

  • The different raw materials and the user impact

  • Impact of raw materials on the timely production of a product

  • The impact of the raw material most used in the production of large molecules and its impact on the user

  • Regulatory requirements for phase 1 through to commercial manufacture

  • The use of additional tests – is it just examining the certificate of competence?

DAY 02 (10:00 a.m. – 4:00 p.m. EST)

  • Using compendial tests instead of lay tests – pros and cons

  • Regulatory risk (ICH Q9) with raw materials

  • Test requirements – how to sample

  • Test requirements – how to test

  • The impact of ASQ and the square root of N+1 on sample size and attribute testing

  • Case Studies – Deadline to Apply Previous Two Days

  • Examples of Warning Letters

For more information on this training visit https://www.researchandmarkets.com/r/gatj94

Comments are closed.