Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene therapy 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:

  • Compare and Contrast FDA, Health Canada, ICH, USP and EP requirements
  • Review latest updates to include FDA, Health Canada, ICH, 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 (Phase appropriate), to include microbial and endotoxin, 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.
  • Review packaging and storage requirements and their impact on in-coming materials to include both raw materials and API.
  • Explore ASQ testing to include how to choose attributes and sample size.
  • Determine when the ASQ vs. square root of N+1 is appropriate.

The objective of this FIVE HOUR/DAY, ON-LINE two day highly interactive ComplianceOnline 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 to include ICH Q7, Q9 and Q11. Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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 to include any bacterial and endotoxin issues 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—why safety is required as part of Phase 1
  • Initiation of additional testing -- when?
  • Examination of regulatory risk to include ICH Q7, Q9 and Q11.
  • Why use compendial testing in lieu non-compendial testing.
  • Testing requirements -- when is enough?
  • Understand packaging and storage requirements and their impact on in-coming materials to include both raw materials and API.
  • The impact of ASQ vs. square root of N+1 on sample size and attribute testing.

Who Will Benefit:

Those who will benefit from this ON-LINE seminar include:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality Control
  • Microbiology
  • In-coming Materials
  • Document control specialists
  • R & D
  • Project Managers
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(10:00 AM - 4:00 PM EDT)
  • Compare and Contrast FDA, Health Canada, ICH, USP and EP requirements.
  • The various raw materials and the user impact
  • Impact of raw materials in the timely production of a product
  • The impact of the single most used raw material in large molecule production and its impact upon the user
  • The regulatory requirements for Phase 1 through commercial manufacturing
  • The use of additional testing – does one only review the C of A
Day 02(10:00 AM - 4:00 PM EDT)
  • The use of compendial testing in lieu of non-compendial testing – pros and cons
  • Regulatory risk (ICH Q9) with raw materials
  • Testing requirements – how to sample
  • Testing requirements – how to test
  • The impact of ASQ and square root of N+1 on sample size and attribute testing
  • Case Studies – Time to apply the previous two days
  • Warning Letter examples
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Barry A. Friedman

Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from The Ohio State University in Microbiology.

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Register Now

Online using Credit card

$1,499.00

(One Attendee)

March 16-17, 2023, Philadelphia, PA
(Registrations till February 25, 2023 - $1499)
(Registrations after February 25, 2023 - $1899)

$8,999.00

Group-Max. 10 Attendees

March 16-17, 2023, Philadelphia, PA
(Registrations till February 25, 2023 - $8,999)
(Registrations after February 25, 2023 - $10,999)



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Cancellations and substitutions for In-person Seminars:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

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Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
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  • Testimonials

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    The seminar was well coordinated and organized. I like how speaker point out to links for more details.

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    The interaction between the presenter and participant is great. ComplianceOnline.com provides useful courses and practical seminars.

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    Revance Therapeutics

    One of my colleagues referred me to this seminar. The subjects are well chosen and presenter is very knowledgeable. I liked the session on "ASQ Sampling, Supplier Change Notifications".

    QC Sr. Specialist,

    Raw Material Support,

    Bayer HealthCare LLC

    I like the info provided about "Vendor Qualification Requirements".

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    I was looking for a good overview of the RM World and speaker provided in-depth knowledge about it. I liked all sessions of this seminar. Speaker is very knowledgeable.

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    Upsher-Smith Laboratories, Inc.

    I liked the case studies and presentation given on day 2 of seminar.

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    Dermira, Inc.

    Real world examples of warning letters are very useful.

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