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            <p> You'll have access to single log-in for an archived recording of the entire 2 day virtual seminar including the Q&amp;A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio
              recording and transcript for the entire session. Delivery is approximately 48 hours after the session</p>
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RAW MATERIAL REQUIREMENTS (HEALTH CANADA/USP/EP) IN A CGMP ENVIRONMENT - ISSUES
AND SOLUTIONS SEMINAR

MP3 DOWNLOAD / ON DEMAND

COURSE INSTRUCTOR BARRY A. FRIEDMAN, PH.D

Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena




2-DAY VIDEO CONFERENCE

Various parts of the country are still battling the Coronavirus (COVID-19), we
will conduct the class 100% online.




Purchase Options


COURSE DESCRIPTION

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 WCS
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.


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


AGENDA

DAY 01(10:00 AM - 4:00 PM EDT)

10.00 AM: Session Start

 * 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


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.


CGMP TRAINING | QUALITY CONTROL CERTIFICATION COURSES ONLINE

FACULTY BARRY A. FRIEDMAN (30+ YRS EXP)

Ph.D. at The Ohio State University

 * Sarasota, Florida, United States

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.



CHOOSE A PRICING OPTION

$2,259.81


RECORDED ACCESS SINGLE PARTICIPANT



Less

You'll have access to single log-in for an archived recording of the entire 2
day virtual seminar including the Q&A period. You can log in any time of day or
night. You'll also receive all presentation materials, plus an audio recording
and transcript for the entire session. Delivery is approximately 48 hours after
the session

Register Now

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