ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course
Instructor:
Barry A Friedman
Product ID: 706881
- Duration: 90 Min
Why Should You Attend:
With the multi-national focus on both raw materials and the Active Pharmaceutical Ingredients formed from them, those involved in sourcing both the raw materials as well as those Active Pharmaceutical Ingredients must consider not only raw materials and APIs sourced within the U.S., but also overseas. The ICH Q7A Guidance provides harmonized guidance regarding the manufacturing of APIs up to that point where the APIs are rendered sterile. Whenever a material is classified as an API throughout the world, it should be manufactured according to the ICH Q7A guide regardless of where it is consumed.
Areas Covered in the Webinar:
- Introductory information regarding API GMPs and ICH Q7 for pharma and biologic products
- Quality Risk Management, and Quality System Inspection Techniques
- Materials Management to Include Sampling and Testing of Raw Materials
- Laboratory Controls for Testing of In-Coming Raw Materials and Intermediates
- GMP Documentation and Change Controls
- Facilities and Utility System Design and Maintenance
- Processing and Process Equipment, and Production In-process Controls
Who Will Benefit:
- Quality Assurance
- Quality Control
- Microbiology/Analytical
- R&D Development
- Technical Services
- Validation
- Project Management
- Plant Management
Barry A. Friedman
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. 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.
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.
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 (PharmaWebinars), IPA (Canada), Executive Conference Corp, Compliance On-Line and Pharmig (UK).
Dr. Friedman 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 to assist with finding the appropriate Warning Letter and FDA 483. 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.
More Training By Experts
- Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)
- Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data
- Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs
- USP <61>/<62> Microbiological Enumeration and Examination of Non-Sterile Products – Understanding the Current Standards for the Revised USP and Harmonized EP Microorganisms
- Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
