Live Webinar GMP Fundamentals

Register online | Download Registration Form (PDF)

Dates Available

March 21, 2019

Time

1:00 p.m – 3:00 p.m.

Cost

CAD $345.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Distinguished Faculty

Ms. Deborah Gordon B. Sc

Instructor and Program Chair
AAPS

Deborah Gordon, B. Sc., Dip. Pharm. QA, began her career in the Sciences as a Forensic Analyst working on crime scenes and in the lab, analyzing evidence to be presented in court. Her attention to detail, which was critical to crime scene investigation, eventually led her to the Quality Assurance field. Her experience as a Forensic Analyst paved the way for her career growth. In 2008, Deborah completed her training as an Auditor by successfully passing the American Society for Quality Auditor examination, (ASQ, CQA).

Deborah has 16 years of experience in the pharmaceutical industry, including 15 years of auditing experience. Her experience includes Quality Systems for storage, distribution, wholesaling, packaging/labeling and manufacturing of pharmaceuticals. She has done extensive work in temperature mapping of warehouses, fridges and freezers. As a leader in pharmaceutical quality assurance, she also enjoys the challenge of auditing and teaching.

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