Writing Effective Standard Operating Procedures (SOPs) For Medicinal Marihuana (MMPR) & Pharma Industries

This course reviews the regulatory requirements (GMP/GLP and MMPR) of SOP’s and their role in License Producer's operations. It then launches into a series of topics, interactive exercises and group discussion on how to write effective SOP’s and manage and maintain this critical documentation system.

The workshop emphasizes practical issues such as:

• The benefits of SOP’s
• The logical approach to defining the SOP procedure
• List of SOPs required for Licensed Producer or Establishment Licensing
• Writing SOP’s
• Critiquing an example of a badly written SOP
• Applying learned techniques to a specific task and writing a SOP

The course provides ample opportunities for group discussions, case studies and exercises. It enables participants to gain the skills and knowledge necessary to meet the Health Canada’s and other regulatory agencies’ expectations.

WHO SHOULD ATTEND

This One-day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medicinal Marihuana Licensed Producers, Medical Devices and allied industries with daily responsibilities in the following areas:

• Quality Assurance

• Documentation and Technical Writing

• Quality Control Laboratory

• Regulatory Affairs

• R&D

• Project Management

• Analytical Laboratory

• Product Development

• Contract Laboratory

• Training

• Product Submission

• Consultant

• Validation

• Others who interact together to launch a product

1. Overview of Regulatory Requirements (GMP and MMPR)
2. The role of SOP’s in Quality Documentation systems
3. SOP List
4. SOP Maintenance
5. Designing an SOP Template
6. SOP writing and Ensuring the Flow of the Document
7. Writing Tips for a Concise, Unambiguous Document
8. SOP’s as a training tool
9. The Change Control System related to SOP

Writing SOP’s 
Critiquing an example of a badly written SOP

8:00 am - 9:00 am
Registration & Continental Breakfast

9:00 am – 9:05 am 
Opening Remarks

9:05 am -10:45 am 
Course Begins

10:45 am -11:00 am 
Mid-Morning Refreshments

11:00 am -12:45 pm 
Course Cont’d

12:45 pm – 1:45 pm 
Luncheon

1:45 pm – 3:30 pm 
Course Cont’d

3:30 pm – 3:45 pm 
Afternoon Break

3:45 pm – 5:00 pm 
Course Cont’d

5:00 pm 
Conclusion of Programs

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."

Presentation Materials, Luncheon, Refreshment and Free Parking

Note: Please indicate any special Dietary requirements when registering for the course.