Complaints, Adverse Events and Recalls For the Medical Marihuana Industry
Details
During this course, you will learn all relevant aspects to efficiently organise and improve your complaint Handling and Recall and Adverse Reaction System to fulfil current MMPR requirements.
In principle, every complaint or adverse reaction might cause a recall, and every complaint may provide an opportunity to improve. According to the MMPR regulations, the Licensed Producer must review all complaints and other information concerning potentially defective product carefully according to written procedures. Additionally a system should be designed to investigate the need and initiate (if necessary) the recall. According to the MMPR, Licensed producer should have a designated person responsible for handling the complaints and deciding the measures to be taken. The Quality Assurance (QA) should be made aware of any complaint, and be actively involved in the investigation and any subsequent recall.
Who Should Attend
These programs are designed for your QA/QC, Regulatory, SPIC/RPIC, Production, and Operation Personnel and Managers and Quality Consultants.
Outline
This course will help your organization establish a comprehensive process for initial intake and triage of customer complaints, adverse reaction reporting and any subsequent recalls.
Course Outline- Review of the regulations MMPR - Sections 59-63
- Complaint Handling System Essentials
- Characterizing complaints and conducting investigations
- Risk management and determining the necessary actions:
- Data handling and trending
- Implementing corrective actions
- Failure analysis and establishing preventative actions
- Follow-up and closure
- Standard Operating Procedure(SOP)
- Organizational and functional responsibilities, QA, SPIC, RPIC
- Documentation and Record Keeping Requirements
- Customer response letters
- Critical linkages with Adverse Event Reporting System
- Adverse Events Reporting Regulatory Requirements
- Classification of reportable incidents
- Reporting requirements:
- Documentation
- Compliance Enforcements
- Effective Recall Management
- Events that can lead to a recall (e.g. Out of Specification, Complaints, etc)
- Purpose of a recall
- MMPR requirements
- Recall Process
- Roles and responsibilities
- Investigation
- Risk assessment and strategy
- Effective communication
- Market withdrawal
- Recall Closure
- Product reconciliation
- Recall effectiveness check
- Preparing the final report
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."
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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