Live Webinar GMP Fundamentals
February 8, 2019
1:00 p.m – 3:00 p.m.
CAD $345.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Instructor and Program Chair
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.
Health Canada Guide 0069, Temperature Control of Drug Products during Storage and Transportation requires drug products to be “transported, handled and stored in a manner that mitigates the risk of exposure to temperatures outside labelled storage conditions; potentially impacting the safety, quality and effectiveness of the drug product…..fabricators, packagers/labelers, distributors, importers and wholesalers are additionally responsible for the appropriate handling, storage and distribution of drugs according to C.02.015 of the Food and Drug Regulations”. Other Regulatory bodies such as the FDA also require the temperature of storage areas to be maintained in accordance with labelled storage conditions in order to maintain drug safety, quality and efficacy.
GMP Temperature Mapping should be completed on a periodic basis, for example every three years in order to demonstrate continuing compliance. Temperature Mapping should also be completed when significant changes have been made to the equipment and storage areas which could impact air circulation or loading or unexplainable variability in temperature occurs outside of the specifications.
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.
- 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
- Product Development
- Others who interact together to launch a product