Objective
To provide the trainees with a comprehensive understanding of the Health Canada GMPs requirements to ensure an effective overall approach to product quality control and risk management by setting appropriate standards and practices for product manufacturing, storage and distribution.
Learning Outcome
After completing this course, the participants should be knowledgeable about all Good Manufacturing Practices elements (Premises, People, Process and Product).
Also, a background information on Quality Management system and the role of Quality Control department are presented to guarantee that the drugs are of the quality required for their intended use. It incorporates GMP to secure that the finished products meet the requirements for product quality, safety and efficacy.
Who will benefit
Regulatory and Quality assurance
- Government personnel (inspectors).
- Plant operational (production) supervisors
- Middle-to-senior management
- Newly hired plant technicians
Handout Materials
When the training is conducted On-Site, trainees will be given a binder, containing the training course slides and the exercises materials.
Sources(Guidelines)
Health Canada: Good Manufacturing Practices guide for drug products (GUI-0001) Version 9 (2020).
Know your instructor
Dr. Jalal Mokhalalati, B.Sc., M.Sc., Ph.D.
Dr. Mokhalalati holds a Ph.D. degree in the field of human nutrition from University of London. Since his graduation in 1981, he wrote a number of books and scientific papers, and he worked in various countries for different sectors, including teaching at the University of Gaza.
In 2001, Dr. Mokhalalati retired from Abbott Laboratories as the Head of Medical and Regulatory Affairs Department in S. Arabia and started his own consultation office in Canada to serve the food & drug industry in all aspects of establishment licensing (GMPs), and Health Products registration with Health Canada.
Ratings & Reviews
Certification
Trainees who participate in this program will receive a “Certificate of Achievement” from QMRS Education Center
Table of Contents
Drug Good Manufacturing Practices Health Canada Parameters
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Before Starting
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Module One: Prerequisite Information (1)
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Module One: Prerequisite Information (2)
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Module Two: Premises (C.02.004)
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Module Two: Equipment (C.02.005)
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Module Three: Personnel (C.02.006)
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Module Four: Sanaitation – Premises (C.02.007)
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Sanitation – Employees (C.02.008)
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Module Five: Raw Material Testing (C.02.009)
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Raw Materials Testing(C.02.010)
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Module Six: Manufacturing Control (C.02.011 and C.02.012) – 1
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Module Six: Manufacturing Control (C.02.011 and C.02.012) – 2
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Module Six: Manufacturing Control(C.02.011 and C.02.012) – 3
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Module Six: Manufacturing Control (C.02.011 and C.02.012) – 4
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Manufacturing Control (C.02.012) – 1
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Manufacturing Control (C.02.012) – 2
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Module Seven: Quality Control Department (C.02.013, 014 & 015)
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Quality Control Department Operational Responsibilities
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Lab Testing
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Module Eight: Packaging Material Testing (C.02.016)
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Packaging Material Testing (C.02.017)
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Module Nine: Finished Product Testing (C.02.018)
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Finished Product Testing (C.02.019) – 1
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Finished Product Testing (C.02.019) – 2
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Module Ten: Records (C.02.020, C.02.021, C.02.022, C.02.023 and C.02.024) – 1
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Module Ten: Records (C.02.020, C.02.021, C.02.022, C.02.023 and C.02.024) – 2
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Module Eleven: Samples (C.02.025 and C.02.026)
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Module Twelve: Stability (C.02.027)
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Module Twelve: Stability (C.02.028)
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✅ Checklists – Stability – Potency
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✅ Checklists – Stability – Purity
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✅ Checklists – Stability – Physical Characteristics
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Sterile Products (C.02.029)
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Course Completion