Quality Risk Management for Pharmaceuticals 03 (PQRM03)
This introductory one day course is outlines the key concepts contained in ASTM 2500E and ICH Q9 and how to apply the standard / guideline.
For example;
- Quality Assurance personnel
- Quality Control personnel
- Operations and Manufacturing personnel
- Validation personnel
"In relation to pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as well as government and industry, the protection of the patient by managing the risk to quality should be considered of prime importance."
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE - QUALITY RISK MANAGEMENT Q9 November 2005
Learning Objectives and Course Description
This course includes:
- understand the basics of Quality Risk Management
- awareness of FEMA
- ASTM 2500
- ICH Q9
- understand the regulatory requirements relevant to Quality Risk Management
- Quality Risk Management and the trends evident within our industry
- the critical processes of Quality Risk Management
- the importance of knowledge and how to manage knowledge in a Quality Risk Management context
- understand Risk Based compliance, Risk Based decisions and how to focus efforts on the greatest risks to patient safety and product quality
- extensive tuition in Risk modelling
- what regulators will expect in Quality Risk Management policies, procedures and justification documents
- understand the intent of the ICH Q8, Q9 and Q10 documents
- lead Quality Risk Management forums
- Subject Matter Experts and their roles in Quality Risk Management
This one day course is intended to provide participants with a working knowledge (illustrated by recent examples) and understanding of the current cGMP.
Benefits include
- learning from experienced professional trainers
- understanding Risk Management and its applications for shop floor personnel
- one on one tuition during the course as the classes and are small and intimate
- receipt of a complete training kit, trainer’s notes and a certificate of completion for participants assessed.
View schedule and how to make a booking.
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