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

Dates :Thursday February 25th, 2021 - Friday February 26th, 2021

Location :virtual Seminar
6201 America Center Drive
Suite 240
95002 San Jose, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

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.
 

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.

Program

Day 01(10:00 AM - 4:00 PM EST)
  • 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 EST)
  • 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


 

Speakers

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.

Organizing committee

Complianceonline
 

Location

Map and directions
Conference address :
virtual Seminar
6201 America Center Drive
Suite 240
95002 San Jose
United States
tel : +1-888-717-2436
Map and directions

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Details

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Pharmacy
raw materials requirements, cgmp requirements for raw materials, raw material testing requirements, raw material requirements in a cgmp environment training, compendial and non-compendial testing, ich q9, health canada requirements
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