Fundamentals of Quality Assurance for Medical Marihuana (GPP)
Details
Attendees will be given ample opportunity to ask questions and to learn about the vast scope of responsibility that the quality system regulations expect
Outline
- Marihuana for Medical Purposes Regulations-Review Expectation and Current Guidance
- MMPR Requirements for the Quality Assurance
- Responsibilities of the Senior Person In Charge (SPIC), Responsible Person In Charge (RPIC), Quality Assurance Person
- Good Production Practices
- Premises
- Equipment
- Sanitation Program
- Destruction
- Deviations
- Recall
- Complaints
- Retained Samples
- Adverse Reactions and Pharmacovigilance
- Record Keeping and Good Documentation Practices (GDP)
- Training
- Standard Operating Procedure
- Structure, Essential Elements
- How to Write and Implement them
- Analytical Testing
- Required Testing
- Product Specification
- Analytical Method Validation Requirements
- Certificate of Analysis
- Out of Specification Result (OOS)
- Outsourcing and Quality Expectation
- Packaging, Labelling and Shipping
- Security
- Audits
- How to Prepare for Audits
- Health Canada Audits
- Self Audits
- Supplier Audit
Speaker/s
Professor
AAPS
Peivand holds a Ph.D. in Physiology and Biophysics from the School of Medicine, University of Sherbrooke (Quebec, Canada), a M.B.A. from American Business Administration Institute (Maryland, USA), and he is accredited by the Canadian Council of Pharmaceutical Education with certifications in Evidence Based Medicine, Psychiatry, and Management. His B.Sc. in Physiology and Cell Biology and M.Sc. in Neurophysiology and Psychophysiology were obtained from University of Pierre et Marie Curie (Paris, France), and his M.Sc. in Biology was obtained from University of Quebec in Montreal (Quebec, Canada).
Peivand’s industrial experience (Wyeth/Pfizer/ApoPharma/Apotex) covers the management of more than 40 international clinical studies for pre and post marketing phases and participation in pre and post marketing regulatory activities and strategic planning. Peivand provides companywide corporate and sales training on multitude of subjects.
Peivand’s academic experience includes medical research and teaching since 1991 at U of Quebec in Montreal (School of Biological Sciences), U of Montreal (School of Medicine), U of Sherbrooke (Faculty of Sciences), Humber Institute of Technology and Advanced Learning (School of Health Sciences) and Seneca College of Applied Arts and Technology (School of Social Worker and Immigration and Faculty of Continuing Education). As a professor in graduate and post graduate programs, Peivand's experience includes teaching Pharmaceutical Clinical Research and Regulatory Affairs, Quality Control and Audits, Compliance, Bioethics, Clinical Pharmacology, Psychiatry, Psychophysiology, Neurophysiology, Medical Biochemistry, Microbiology, Microbial Ecology, Virology, and Genomics.
Peivand has authored more than 65scientific realizations, including 12 publications in National Library of Canada, articles in peer-reviewed journals, oral and poster presentations, and more than 1000 technical and scientific reports. Every year, Peivand mentors more than 120 postgraduate students in Clinical Research and Regulatory Affairs.
Peivand has received several awards and recognitions including “A Scientific Recognition and Award” from His Very Honorable Bernard Landry, the Prime Minister of Quebec, Canada in 1995 and a letter of commandment from the Dean, School of Health Sciences, Humber Institute of Technology and Advanced Learning for teaching excellence in 2008.
Peivand is actually teaching at Advanced Academy of Pharmaceutical Sciences (AAPS), Humber Institute of Technology and Seneca College of Applied Arts and Technology in Clinical Research and Regulatory Affairs programs and is an independent consultant."
Note: Please indicate any special Dietary requirements when registering for the course
Special Offer
If you are unable to attend we can come to your site. Contact us
Registration Fee Includes
Presentation Materials, Luncheon, Refreshment and Free Parking
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