- Banking & Financial Services
- BANKING & FINANCIAL SERVICES
- Banks and Credit Unions
- Financial Services and Trading
- Insurance
- Accounting and Taxation
- Life Sciences
- Hitech, Aero & Manufacturing
- HITECH, AERO & MANUFACTURING
- Quality & Safety
- Standards and Methodology
- Energy & Utilities
- ENERGY & UTILITIES
- IT Security
- Reliability (NERC / FERC)
- Quality and Safety
- Risk Management
- CPG & Retail
- CPG & RETAIL
- Retail Audit
- Quality & Safety
- Social Compliance
- Healthcare
- Food & Dietary Supplements
- Cross Industry Functions
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 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.
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:
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Manufacturing engineers
- Quality engineers
- Quality auditors
- Quality Control
- Microbiology
- Document control specialists
- R & D
- Project Managers
- 08.30 AM - 09.00 AM: Registration
- 09.00 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
- 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
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.
Location:
Boston, MA
(Venue to be announced shortly)
August 24-25, 2020
Testimonials
See What People Say About Us
Quality Control,
Gilead Science
QC Lab Supervisor,
Revance Therapeutics
QC Sr. Specialist,
Raw Material Support,
Bayer HealthCare LLC
Senior Associate,
Quality Assurance,
Arbutus Biopharma Corporation
Supervisor,
Laboratory Operations,
Upsher-Smith Laboratories, Inc.
Director CMC,
Dermira, Inc.
Supplier Quality,
Sanofi Pasteur Inc.
Chemistry Specialist,
Bayer HealthCare LLC
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
- Logo on website, marketing email, branding materials & the registration booth
- Exhibit Space
- Free event pass
- Speaking opportunity
- Social media campaign
For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656
Media Partner:
PharmiWeb.jobs is Europe’s largest specialist Pharma Job board. Thousands of active job vacancies listed from hundreds of employers across the UK and Europe; PharmiWeb.jobs is the best place to find your next career move. All you need to do is register and upload your CV.”
Pharmaceutical-Tech is essentially a B2B online business, technology media platform and global magazine that have under its wraps the largest global database of Pharmacy buyers and suppliers. We cover in-depth trends that shape industry dynamics and metamorphose global economics. Pharmaceutical tech has created a recognition that spans over a global audience, thereby revolutionizing how businesses transact.
Local Attractions of Boston, MA
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
North End
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.
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