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Raw Material Requirements (Health Canada/USP/ICH/EP) in a GMP Environment – Issues and Solutions

May 23 - May 24

Location: Toronto, Canada

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:

  • Consider Health Canada, FDA, 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.
  • Explore ASQ testing to include how to choose attributes and sample size.

The objective of this two day highly interactive 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 GMP compliance framework to include ICH Q7, Q9 and Q11.

Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues

Learning Objectives:

Upon completing this course on raw material requirements in a GMP 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 of non-compendial testing.
  • Testing requirements — when is enough?
  • The impact of ASQ on sample size and attribute testing.

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

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, 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 compliance interactions.

Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology. In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi, TungstenShield, IPA (Canada), Executive Conference Corp., Compliance OnLine, and Pharmig (UK). He maintains an active Blog (www.barryafriedmanphdllc.com/) that contains over 200 Blogs that address various Warning Letter and FDA 483 issues as well as over 1,500 “Search” terms.  He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.

This unique two-day seminar is for professionals in the pharmaceutical, biopharmaceutical and life science industries with responsibilities in the following areas:

  • Quality Assurance professionals
  • Regulatory Affairs professionals
  • Compliance professionals
  • Manufacturing
  • Quality auditors
  • Quality Control
  • Microbiology
  • Document Control specialists
  • R & D

Registration Fee & Discounts:

Early Bird: Till April 24, 2019

Regular Price: April 25, 2019 to May 23, 2019

$788 CAD + HST $988 CAD + HST

 

Academia / Government

At all time 

$688 CAD + HST

The fee is payable in advance and includes continental breakfast, lunch & refreshments, course material and certificate of attendance.


Group Registration Discount
Group Registration is available for all our live events. Please contact us: By email: enquiry@ipacanada.com or Call: 416-410-7402

Cancellation Policy
Cancellations received in writing more than 3 weeks before the event will be subject to a service charge of $150.00 CAD. The full conference fees remain payable if cancellations are received less than 3 weeks prior to the event. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organizer to alter the timing of the program or the identity of the speakers. In the unfortunate event that an event is cancelled IPA are not liable for any costs incurred by delegates in connection with their attendance.

Course Venue & Hotel Accommodation

Stay Tuned….information will be available soon.

 

 

 

Details

Start:
May 23
End:
May 24
Event Category:
Event Tags:
,

Venue

Toronto, Canada

Organizer

IPA
Phone:
(416) 410 7402
Email:
enquiry@ipacanada.com
Website:
http://ipacanada.com