BEGIN:VCALENDAR PRODID:-//Microsoft Corporation//Outlook 12.0 MIMEDIR//EN VERSION:2.0 METHOD:PUBLISH X-MS-OLK-FORCEINSPECTOROPEN:TRUE BEGIN:VEVENT CLASS:PUBLIC CREATED:20100122T154923Z DESCRIPTION:Just a friendly reminder that dicentra’s online seminar on Su ccessful Product Submissions will take place this coming Wednesday. Visit www.dicentra.ca/training to register now.\n\nSuccessful Product Submission s: How to Register Your Multi Ingredient Products for Unique Health Claims \nWednesday\, February 24\, 2010\, 1:00 PM Eastern Time\n60 minutes follow ed by a 30 minute question and answer period\nAnne Wilkie\n1 Certificate o f Course Completion issued to the attendee\, and archive of the PowerPoint and audio to keep forever\n \n\ nAs of November of 2009 the Natural Health Products Directorate (NHPD) has completed 33\,000 of 43\,000 product license applications received. Out o f these 48% have either been withdrawn by the applicant (11%) or refused b y the NHPD (37%). Later this fall the NHPD is expected to make an announce ment on new enforcement measures with potential target dates as to when pr oducts will absolutely require a license before entering the marketplace.\ n\ndicentra’s 2010 Successful Product Submissions Web Seminar will addre ss the many challenges facing industry in obtaining Natural Product Number s and will provide potential solutions to overcome these challenges. This seminar is presented only once a year and is derived from dicentra’s exp erience in completing thousands of Product License Applications. Topics co vered include:\n* a summary of the recent NHPD workshops outlining complia nce and enforcement measures\;\n* an update on the status of submissions a t the NHPD\;\n* an overview of the product submission review process that takes place at the NHPD\;\n* a list and discussion of reasons why products are being refused\; and\,\n* what can be done to improve the likelihood t hat your product will be approved\, especially for non-traditional applica tions. \nThe seminar presenter\, Anne Wilkie\, is the former Vice Presiden t and Head of Regulatory Affairs for the Canadian Health Food Association\ , Canada's largest trade association representing the interests of retaile rs and suppliers of natural products and organics. Anne held this role for the past 10 years during which time she developed and led the regulatory program for the CHFA and was actively involved in the creation and impleme ntation of the Natural Health Products Regulations and consultations on th e Organic Products Regulations. Prior to the CHFA\, Anne worked for Health Canada and the Canadian Food Inspection Agency in a variety of roles incl uding Laboratory Analyst\, Food and Drug Inspector and Nutrition Program S pecialist.\n\nAnyone involved in preparing submissions for Product License Applications should attend this course to fully understand the review pro cess at the Natural Health Products Directorate and to acquire the ability to submit a complete and successful application.\n\n DTEND:20100728T193000Z DTSTAMP:20100122T154924Z DTSTART:20100728T170000Z LAST-MODIFIED:20100122T154923Z LOCATION:Online PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:Dicentra Online Seminar: GMP Training TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E0080000000010DB44D24F9BCA01000000000000000 010000000D9872C999A33A24583E9323AB602F9BA X-ALT-DESC;FMTTYPE=text/html:\n\n\n\n\n\n\n\n\n

Just a friendly reminder that dicentra’s online seminar GMP Training will take place this comi ng Wednesday. Visit www.dicentra.ca/training to register now.

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Good Manufacturing Practices Train ing for Natural Health Product Site License Holders
\nWednesday\, July 28\, 2010\, 1:00 PM Easte rn Time
\n120 minutes followed by a 30 minute question and answer period
\ nWilliam Morkel\nCertificates of Course C ompletion issued for up to 5 attendees and 1 corporate certificate for GMP training
\nAr chive of the PowerPoint and audio to keep forever

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\nAll facilities involved in the manufacturing\, importing\, packaging or labeling of natural health products in Canada should now have a Site Lice nse from the Natural Health Products Directorate (NHPD). This requirement has been in place now for over two years and in the interim\, policies and procedures have changed as the NHPD has raised its expectations in terms of the documentation required to support an application. At the heart of a successful license application or renewal is compliance with the Good Manufacturing Practices (GMPs). Manufacturers\, packagers\, importers\, and labelers must implement a GMP compliant q uality system and must ensure that individuals on staff receive initial an d ongoing GMP training. This course\, prepared and delivered by William Mo rkel\, will provide participants with the information and tools necessary to facilitate compli ance with the regulations and will address issues and concerns with the in terpretation and implementation of the GMP requirements.
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\nThis c ourse is specifically designed for potential and current Site License hold ers. Any personnel directly involved in the manufacturing\, importing\, packaging or labeling of natural health products should attend this course in order to ensure th at they have adequate training to control and supervise these activities u nder GMP requirements.
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\nWilliam Morkel\, Senior Regulatory Affairs &\; Quality As surance Specialist at dicentra\, has ten years of experience working in th e field of pharmaceutical and natural health products quality assurance an d often delivers lectures on GMP issues with Health Canada. This seminar has been presented by William to many of Canada’s largest companies in the natural health pro duct industry as part of their annual GMP training.
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