“Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment – Issues and Solutions” Seminar has been added to ComplianceOnline.com’s offering.
SAN JOSE, CA, UNITED STATES, April 8, 2021 /EINPresswire.com/ — Registration is now open for ComplianceOnline’s 2-day virtual seminar ‘Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment – Issues and Solutions’. Barry A. Friedman, Ph.D. will be the speaker for this virtual event on April 29-30, 2021 (10:00 AM to 4:00 PM EDT).
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 organizations maintain themselves 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.
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
• In-coming Materials
• Document control specialists
• R & D
• Project Managers
For more information or to register for this seminar, please click here.
Virtual Training Through WebEx
Date: April 29-30, 2021 (10:00 AM – 4:00 PM EDT)
About the Speaker:
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.
ComplianceOnline is a leading provider of regulatory compliance training programs for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 55,000 professionals from 15,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California, and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC), and Quality Management Solutions for global corporations.
For more information on ComplianceOnline or to browse through our training programs, please visit our website