GMP Fundamentals

Recorded Webinar Time: 2 Hours Cost: CAD$600+HST Buy Now!

Description

In order to ensure appropriate and consistent quality of medicinal/herbal substances, it is necessary to establish good practices in growing, harvesting, and processing operations. Canada’s Access to Cannabis for Medicinal Products Regulations (ACMPR) requires Licensed Producers to implement and adhere to Good Production Practices (GPP). In Europe, European Medicinal Agency (EMEA) requires adherence to Good Agricultural and collection Practices (GACP) for growing and harvesting. Both GACP and GPP are designed to ensure full traceability back to the seed source for each crop. Following GACP and GPP standards ensures that only the highest quality plants are grown and harvested.

Course Overview

This webinar examines the history, rationale, purpose, and GMP requirements applicable to the manufacturing, packaging and labeling, testing, and control of pharmaceutical products and consequence of inaction.
Gain practical knowledge in understanding of the essential elements and quality systems required for GMP and for maintaining compliance in the pharmaceutical industry.

Course Outline

  • Assuring Quality in the workplace
  • The benefits of GMP compliance
  • Management Responsibilities for GMP
  • SISPQ/principles of drug production
  • Principles of GMP
  • Training/Effective Training Requirements
  • GMP Documents
  • Standard Operating Objectives
  • Quality Control/Quality Assurance
  • Methods and Specifications
  • Sanitation Programs
  • Out of Specification and Deviation Investigations
  • Production Controls
  • Good Documentation Practice
  • Record Keeping
  • Validation and their types
  • Effective Change Control
  • Industry Trends
  • Hosting Inspectors and Auditors

WHO SHOULD ATTEND

This course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

  • Regulatory Affairs
  • Clinical Research
  • Quality Assurance
  • Documentation and Technical Writing
  • Product Submission
  • Project Management
  • Training
  • Product Development
  • Consultants
  • Others who interact together to launch a product