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Pharmaceutical Quality: QRM, CAPA & RCA

Event Date 05- 06 December 2019, Location – Austria

OVERVIEW OF PHARMACEUTICALS QUALITY MASTERCLASS

This 2-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.

WHO SHOULD ATTEND THIS PHARMACEUTICALS QUALITY TRAINING?

  • QA Managers and Inspectors should attend this Pharmaceutical Quality Training
  • QC Laboratory Managers  should attend this Pharmaceutical Quality Training
  • Qualified Persons should attend this Pharmaceutical Quality Training
  • Regulatory Compliance Managers should attend this Pharmaceutical Quality Training
  • Production Managers should attend this Pharmaceutical Quality Training
  • Formulators should attend this Pharmaceutical Quality Training
  • Process Validation and Scale-up Specialists should attend this Pharmaceutical Quality Training
  • Process Development Managers should attend this Pharmaceutical Quality Training
  • Regulatory Compliance Managers should attend this Pharmaceutical Quality Training
  • Chemical Engineers should attend this Pharmaceutical Quality Training
  • Project Management Should Attend This Pharmaceutical Quality Training
  • CMO Managers Should Attend This Pharmaceutical Quality Training
  • Quality Assurance Personnel Should Attend This Pharmaceutical Quality Training
  • Risk Management Should Attend This Pharmaceutical Quality Training
  • Production Management Should Attend This Pharmaceutical Quality Training
  • Maintenance Staff Should Attend This Pharmaceutical Quality Training

KEY TOPICS PHARMACEUTICALS QUALITY MASTERCLASS

• 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

 

KEY TAKEAWAYS PHARMACEUTICALS QUALITY MASTERCLASS

Understand

  • Industry approaches for scaling-up of solid dosage forms applying QbD principles

Learn

  • How to translate theoretical scaleup models and current regulatory guidances into practice – What is really relevant?

Gain

  • transfer and validation for commercial drug production. Practical knowledge during the interactive sessions and workshops

Registration Fee


€2496


Per Participant


Start Time

9:00 am

December 5, 2019

Finish Time

5:00 pm

December 6, 2019

Address

Austria

Online Registration.

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:+44 2032 398083


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