Pharmaceutical Quality: QRM, CAPA & Root Cause Analysis

Place
Hotel Bristol Luxury Collection, Vienna, Austria
Site visit
Dates
3 - 5 February 2020
Who should attend?

QA Managers and Inspectors, QC Laboratory Managers, Qualified Persons, Regulatory Compliance Managers, Production Managers, Formulators, Process Validation and Scale-up Specialists, Process Development Managers, Regulatory Compliance Managers, Chemical Engineers

Summary

This 3-day training course is designed for Pharmaceutical Quality professionals. Delegates will examine Root Cause Analysis(RCA) techniques by applying them to practical examples from the industry. Learn how to meet Corrective Action Preventive Action (CAPA) audit expectations and to maintain control over product and processes in a GMP environment.

Aims

Key Topics

• Application of Quality Risk Management (QRM)

• Regulatory Requirements for RCA, CAPA and OOS

• Causal Analysis: Definition of different types of cause

• RCA techniques, concepts and stages

• Data acquisition and Task analysis

• Principles of Critical Deviation Management (CDM)

• CAPA Audit expectations

• Training/retraining and Human Error

Programme

All training materials will be provided in printed and digital form

All delegates will receive printed and LinkedIn certificates

• CAPA is the pharmaceutical process which outlines how to undertake activities to maintain control over product and processes in a GMP environment

• Without a thorough understanding of CAPA, and the accompanying need for RCA, companies will spend a lot of time and effort in repeatedly correcting faults rather than establishing procedures that will prevent these faults from occurring

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Trainers

Dr. Malcolm Ross

Generapharm

CEO

Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities. His early industrial experience with Teva and Taro were directed primarily to the US markets but later, as President of IPR, a company jointly owned by PAR and Merck Generics, followed by R&D director for Polpharma, his role expanded to include development for the European markets. Technically Malcolm specialized in development, both of formulations and analytical methodologies and holds a number of patents for novel formulations. In 2006 Malcolm moved to Basel and has worked for Novartis in several roles as well as consulting for a wide range of companies on strategic planning and technical matters. He has conducted many training courses throughout Europe and Asia.

Dr. Malcolm Ross

Generapharm

CEO

Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities. His early industrial experience with Teva and Taro were directed primarily to the US markets but later, as President of IPR, a company jointly owned by PAR and Merck Generics, followed by R&D director for Polpharma, his role expanded to include development for the European markets. Technically Malcolm specialized in development, both of formulations and analytical methodologies and holds a number of patents for novel formulations. In 2006 Malcolm moved to Basel and has worked for Novartis in several roles as well as consulting for a wide range of companies on strategic planning and technical matters. He has conducted many training courses throughout Europe and Asia.

Tour info

Testimonial

Price per Delegate (EUR)

2295.00
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Request Full Agenda

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Contact us

Lydia Makori

l.makori@symmetric.events
+421 222 200 543