ARV Excellence and Pharamchemical Ireland have teamed up to deliver a two day programme called: 

Quality By Design: A Systematic Approach to Pharmaceutical Development, Approval and Manufacturing

Participants will gain an understanding of quality by design as it applies to pharmaceutical product development, approval and manufacturing. The course is broad in scope covering the evolution of the regulatory environment – where it was, the current environment and future trends. The programme will cover new quality system design approach to new drug development and the drug approval process. The course will help participants develop an understanding of Quality Risk Management based on ICH Q9 and learn about RiskMAP's. 

Course Outline: 
Day One 
Morning 
Module 1 - Regulatory perspectives on cGMPs 9.00am - 10.30am 
Break 
Module 2 - Principles and Procedures for New Drug Approvals - 11.00am - 12.30am 
Afternoon 
Module 3 - FDA's Drug Compliance and Inspectional Strategies, FDA Enforcement Letters 1.30pm - 3.00pm 
Break 
Module 4 - Good Laboratory Practices (GLP) Requirements - 3.30pm - 5.00pm

Day Two 
Morning 
Module 5 - Quality System Design Control Approach to New Drug Development 
Module 6 - Good Clinical Practice in FDA-Regulated Clinical Trials 
Afternoon 
Module 7 - Guidance for Clinical Investigators, Sponsors, and IRBs 
Module 8 - Manufacturing Methods & Processes for Pharmaceuticals, Bioresearch Monitoring ( BIMO)

For more information please contact Una Clarke: 01 6051535 or email: una.clarke@ibec.ie 

QBD Brochure - training course.pdf (1421kb)

The course has been developed by ARV Excellence associates Dr. Kaiser Aziz and Stan Masterangelo.

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