Drug Product Submission (NDS) Preparation in CTD and eCTD format
December 6, 2019 | 9:00 AM- 5:00 PM
The guidance on marketing applications for drugs and biologics was finalized by the International Council on Harmonization (ICH) in 2003. Today the CTD format is recommended for marketing applications in several countries in the world and is mandatory in several regions including Canada, Japan, Europe and U.S.A..
| | Chemistry, Manufacturing and Controls
| December 6, 2019 | 9:00 AM-5:00 PM
The objective of this course is to provide a strong understanding of the importance and underlying principles for CMC requirements from the regulatory perspective. Participants will gain an understanding of the CMC portion of a
| | HPLC Training and Certificate Program
| January 13 – 24, 2020 | 9:00 AM-5:00 PM
HPLC is a very popular instrument for compound analysis since it is simple to learn and easy to use. Modern HPLC are applied in quality control (QC) and research and development (R&D) to separate, identify, purify and quantify compounds. In the pharmaceutical industry, it is commonly used to quantify the active pharmaceutical ingredient (API)
| | | | January 8, 2020 | 1:00-3:00 PM
This webinar examines the history, rationale, purpose, and GMP requirements applicable to the manufacturing, packaging and labeling, testing, and control of pharmaceutical products and consequence of inaction. Gain practical knowledge in
| | | Cannabis Micro Licence Application Process and Requirements | December 11, 2019 | 2:00-3:30 PM
The Cannabis Act establishes that an application for one of the Micro Cultivation/Processing Licence must be filed with Health Canada in the form and
| | | | | | Health Canada, GPP, and GMP Compliant Facility Design and Build | December 10, 2019 | 2:00-3:00 PM
Based on the recent announcement by Health Canada, prospective applicants of a cannabis cultivation, processing or medical sales licences are required to have fully built regulatory-compliant
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