Raw Material Requirements (FDA/Health Canada/ICH/USP/EP) in a CGMP Environment: Issues and Solutions - New Course
Registration Options
Individual Registration
Group Registration
Duration: 2 Days
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 course on raw material requirements in a CGMP environment will:
- Consider 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
- Explore ASQ testing to include how to choose attributes and sample size
The objective of this two-day highly interactive course 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 Should Attend
Those who will benefit will include:
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Manufacturing engineers
- Quality engineers
- Quality auditors
- Quality Control
- Microbiology
- Document control specialists
- R & D
Contact
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Day 1
Upon completion of this course, you will be able to:
- Explain how various types of raw materials may impact the user
- Discuss 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
- Summarize the requirements for Phase 1 through commercial manufacturing—why safety is required as part of Phase 1
- Discuss the initiation of additional testing -- when?
- Examine regulatory risk to include ICH Q7, Q9 and Q11
- Discuss why use compendial testing in lieu non-compendial testing
- Examine testing requirements -- when is enough?
- Explain the impact of ASQ on sample size and attribute testing
Continuing Education for Pharmacists
PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:
PDA #541 | ACPE #0116-0000-17-044-L04-P | 1.2 CEUs
Type of Activity: Application
Continuing Education for Professional Engineers
New Jersey
PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.
The credit value of this course is 12 CPC credits.
North Carolina
PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.
The credit value of this course is 12 PDHs.
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Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Renaissance Washington D.C. Hotel
999 9th Street, NWWashington, DC , United States
Barry Friedman, PhD, Consultant, Barry A. Friedman, PhD, LLC