GMP Fundamentals

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

Distinguished Faculty

Steven Tanner

Mr. Steven Tanner has worked for and partnered (GQRP) with the top global pharmaceutical manufacturing, contract research, wholesale and specialty distribution organizations in both Europe and North America. From Eli Lilly UK to Merck KGaA (now Mylan) in Canada, Pharmanet (now Inventiv Health), Teva, and the McKesson Corporation, Steven now surpasses more than 18-years of progressive GxP industry experience in quality, compliance and technical training senior leadership roles.

Steven’s specialties include leading FDA and Health Canada GMP inspections, customer 3rd party logistics (3PL) quality & qualification audits, as well as the hands-on design, strategy, execution and management of GxP regulatory quality systems: change controls, deviation controls, CAPA, validation/21 CFR Part 11, document controls, environmental monitoring, complaints, equipment & shipment qualifications, SOPs, technical writing, drug recalls, quality agreements, self-inspections. Steven has also partnered since 2004 with AAPS – Academy of Applied Pharmaceutical Sciences where he’s provided quality assurance/GxP technical facilitation. In 2016 Steven accepted a full-time role as Campus Manager and Director of Student Affairs with AAPS.

Steven graduated in 1999 with an honours degree in Chemistry from Leicester University in the United Kingdom and holds a postgraduate diploma in Adult Education from St Francis Xavier University, Nova Scotia, Canada.

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