VIEWS: 45 PAGES: 2 CATEGORY: Medicine POSTED ON: 5/18/2012
The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements.
Live Webinar on GMP Compliance for Dietary Supplements Course "GMP Compliance for Dietary Supplements" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion. Register Now Date & Time: Instructor Profile: Wednesday, June 13, 2012 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Instructor: Dr. Efrem H. Zaret Dr. Efrem H. Zaret President, EZ Associates Inc. Location: Online Price : $245.00 (for one participant) Dr. Efrem Zaret, President of EZ Associates Inc., is actively engaged Overview: in consulting assignments involved The U.S. Food and Drug Administration issued the final rule with the Chemistry, Manufacturing, establishing regulations to require current good manufacturing Control, and Quality of new and practices (CGMPs) for dietary supplements. existing drug products, dietary supplements and active pharmaceutical ingredients and with The current good manufacturing practices (CGMPs) final rule will the preparation and logistics of require that proper controls are in place for dietary supplements so clinical supplies. He assists clients in that they are processed in a consistent manner, and meet quality the identification and control of standards. The CGMPs apply to all domestic and foreign companies contract service organizations, drug that manufacture, package, label or hold dietary supplements, evaluation and testing, with the including those involved with the activities of testing, quality control, preparation and implementation of packaging and labeling, and distributing them in the U.S. The rule quality systems and with establishes CGMPs for industry-wide use that are necessary to submissions to the FDA. He also does training on GMP principles and require that dietary supplements are manufactured consistently as related topics. to identity, purity, strength, and composition. The requirements include provisions related to: the design and construction of physical Dr. Zaret has industrial experience plants that facilitate maintenance, cleaning, proper manufacturing in the development, manufacturing, operations, quality control procedures, testing final product or packaging and evaluation of drugs, incoming and inprocess materials, handling consumer complaints, foods, nutritionals, and other and maintaining records. regulated products both in the United States and in Europe. Dr. Zaret obtained his B.S. in Chemistry from Why should you attend: the Illinois Institute of Technology The regulations require that you understand the requirements and and his M.S. and Ph.D. degrees in Organic Chemistry from the establish a Quality System designed to meet them. This presentation University of Wisconsin-Milwaukee. will review the requirements and the rationale for them. ...more Areas Covered in the Session: Suggest a Topic More Webinars l History of the regulations and their current status Your Necessity is our Priority l Review of the key points of the regulations l Discussion of methods that can be used to comply with the regulations l Documentation that is required for compliance l The role of the Quality organization l What to expect during an FDA inspection l How to respond to an FDA inspection l Raw material control and incoming inspection l Cleaning and Maintenance Click here to register for this webinar Who Will Benefit: l Senior Management l Quality Control Management and personnel l Manufacturing management and supervisors l Warehouse Management and supervisors l Shipping and Distribution Management and supervisors It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
Pages to are hidden for
"GMP Compliance for Dietary Supplements"Please download to view full document