Session Length: HALF DAY INTERACTIVE TRAINING PROGRAM
Open Session dates: TUESDAY MARCH 26, 2019; 9:00AM – 1:00PM
Pricing: $350 per participant
Fundamentals Of Good Manufacturing Practices
Active Pharmaceutical Ingredient and Product Importation
Health Canada GMP Regulations GUI‐0001, GUI-0104
This half day course presents participants with the essential Health Canada Good Manufacturing Practices (GMPs) requirements for licensed pharmaceutical Importation and Distribution, and is applicable to Active Pharmaceutical Ingredients(APIs), and OverThe‐Counter/Category IV, Prescription and Biological products. All companies with a Drug Establishment Licence in Canada must follow these guidelines. Canadian GMPs are based on the Food and Drugs Act, and are the primary pharmaceutical industry guidance, designed to protect the patient or consumer, and assure the quality of pharmaceutical products.
This assessed and certified course is routinely delivered onsite to Importers and Distributors and is intended to provide participants with the knowledge to complete foundational and ongoing GMP training requirements.
This training also includes a GMP‐relevant understanding of current Health Canada hot topics, describes useful regulatory resources, and addresses proposed changes to the GMP guidance as outlined within the recent industry consultation.
WHO SHOULD ATTEND
- Canadian Importers and Distributors of Over‐The‐Counter/Category IV, Prescription and Biological products
- Canadian Importers and Distributors of Active Pharmaceutical Ingredients (APIs)
- New employees with no formal training in GMP
- Personnel with existing training who need to stay current with GMP
PURPOSE OF WORKSHOP
- Gain a basic understanding of GMP regulations
- Review a brief history of GMP; understand the role of quality control and quality assurance; learn about equipment use, validation, sanitation, labeling, records, records and good documentation; and look at deviations, change control and audits
- Address requirements for Drug Establishment Licensing of APIs and Products
- Shows you how to apply GMP principles to protect patients, and assure the quality of pharmaceutical products
- Provides a methodical approach to GMP that simplifies the regulations and helps you understand how to comply
- Gives you a participant folder, marked quiz, course certificate, indexed cGMP/GMP pocket booklet, and The Personal Action Plan™. The Blue Book™ will be an indispensable reference for your day-to-day activities in the workplace.
- Course accommodates employees new to GMP, or experienced employees needing to stay current with GMP
- On completion, learners meet HPFBI training requirements (as per HPFBI GMP regulations C.02.006)
- Shows you how to implement GMP and avoid nasty surprises in government and supplier audits, or self‐inspections
- Enables you to gain a working knowledge of GMP in a half‐day