JAPM with the support of JFDA & IFC Announces the opening of Registration for the Virtual Workshop:

 

“Risk Management”

 

Risk management and prevention of cross contamination training course

Manufacturers of medicinal products must ensure they do not place patients at risk due to inadequate safety, quality or efficacy.  To achieve this goal, it is a GMP requirement that appropriate attention is paid to those factors that present cross-contamination risks.  This course is designed to help you identify the cross-contamination risks in your facility, identify appropriate risk controls which are designed on the basis of the hazard presented by the materials being handled, and ensuring all measures are correctly implemented via a system of Quality Assurance (QA) incorporating Good Manufacturing Practice (GMP), and Quality Risk Management (QRM) principles.

 

What you will learn in our 3 hour Risk management and prevention of cross contamination training course:

Upon completion of this course participants will understand;

• Quality Risk Management (QRM) principles and typical risk management tools
• How to implement QRM into your Quality System
• Fundamental principles of what is considered to be cross-contamination in a GMP environment
• Application of Health Based Exposure Limits (HBEL) to cross-contamination control
• How to create a cross-contamination risk assessment including what to consider and how to assign the correct risk rating
• Review of PIC/S Aide Memoire(s) “Cross – Contamination in shared facilities” and “Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management” so you know what to expect during an inspection
• Use of case studies so you can practically apply theory to real life.

 

Who should attend?

• Quality Assurance personnel
• Quality Control personnel
• Operations and Manufacturing personnel
• Validation personnel

 

Speaker:

Ashley Isbel

Bio:

Ashley Isbel - Lead Consultant – GMP Services Director 

Among Australia’s leading experts in sterile compliance and validation, Ashley offers 25 years of practical experience as a qualified chemical engineer in GMP-regulated industries (TGA, PIC/S, FDA), including pharmaceuticals, pharmacies, medical devices and blood and tissue.  

Ashley has trained regulatory agencies as well as supported start-up companies to find their way through CFR 820, CFR Part 11, PIC/S, ISO 13485 and 14644.   

His expertise includes lifecycle validation, process engineering and GMP compliance, with specialities in sterile manufacture including next-generation medicines, HVAC systems and cleanroom design and construction. 

Ashley routinely conducts practical gap analysis, performs design reviews and inspections to assist companies to develop compliance road maps and support vendor audits. 

Registration form attached, for registration & more information please email: dana@japm.com

 

Limited Seats, Stay Distant, Stay Safe!