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23-04-2018 (Singapore)

P40074 Critical GMP – The Quality Triangle
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Critical GMP – The Quality Triangle

23 – 24 Apr 2018, Mandarin Orchard Hotel, Singapore

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Team Savings: Register 2 Delegates & the 3rd Comes free!

overview

QRM, CAPA & RCA

Key Learning Outcomes

  • An understanding what current inspectors consider essential in terms of CAPA in order to demonstrate that your company is operating under cGMP
  • An appreciation of how quality is defined by the triangle of Quality Risk Management, Root cause analysis and Corrective/Preventive action.
  • An in-depth analysis of the real meaning of risk and how to approach quality risk management
  • The significance of deviations, their use and limitations
  • Knowledge of how to carry out root cause analysis and how to document it in order to convince regulators that you have carried out a systematic investigation

Who will benefit:

This training course will be of practical importance to the following:
Corporate managers, QA Managers, Qualified Persons, QC Laboratory Managers, Production Managers, Regulatory Compliance Managers, Process Validation Engineers, Process Development Managers, QA Inspectors

pricing

Packages Price
2 Day TrainingSGD $3495Early Bird

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate of 2-day main conference package only.
For Group Registrations, email info@ibcasia.com.sg or call +65 6508 2477

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.

trainer

Malcolm Ross

President, Generapharm

Agenda

INTRODUCTION

  • The two main reasons for cGMP failures
    • Corrective Action/Preventive Action
    • Data integrity
  • Why now and the remedy-the quality triangle and quality culture

THE QUALITY TRIANGLE
The inter-relationship between CAPA and RCA (without RCA there can be no guarantee that CAPA is satisfactory) and QRM (without a genuine risk analysis every deviation in process, production or materials or from an SOP can result in considerable expenditure of time and resources for no additional value).

BASIC UNDERSTANDING OF CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA)

  • Why are CAPA’s necessary?
  • Definitions of correction, corrective action and preventive action
  • When and where are CAPA’s required
    • FDA 21CFR requirements and FDA QSIT expectations
    • Eudralex (Eu GMP)
    • WHO and PIC/s CAPA requirements
  • CAPA within the ICH Quality systems

PRINCIPLES OF CRITICAL DEVIATION MANAGEMENT (CDM)

  • Deviations-planned and unplanned definitions.
  • Levels of deviations-critical, major and minor
  • The application of risk assessment and management to deviations
  • Using CAPAs only for CRITICAL deviations – Risk analysis and management
  • Management and trending of noncritical deviations
  • Trends leading to Preventive Action

INVESTIGATIONS-THE NEED TO DETERMINE ROOT CAUSE

  • The need for an investigative, multidisciplinary team
  • The cultural issues in establishing a root cause analysis
  • Data collection and data integrity
    • The FDA and MHRA guidelines for data integrity
    • Cultural challenges in data integrity
    • Process mapping, Flow charts and walk throughs
  • Causal analysis-proximal and distal

ROOT CAUSE ANALYSIS TECHNIQUES

  • Five whys
  • 5 W’s + 1H
  • Fishbone [Ishikawa] diagrams
  • Change analysis and Barrier analysis
  • Operator error – the train/retrain trap

ANALYTICAL RESULTS AND OUT OF SPECIFICATION OOS AS A SPECIFIC TYPE OF UNPLANNED DEVIATION

  • The introduction of concept of OOS as a legal requirement
  • The FDA and MHRA guidance simply specific examples of CAPA
  • The demand for investigation which follows principles of RCA
  • The extension of OOS to Out Of
  • Trend and Out Of Expectation

when & where

23 - 24 Apr 2018

Mandarin Orchard Singapore, by Meritus
333 Orchard Road, Singapore 238867
Tel: +65 6831 6062 | Fax: +65 6737 3130
Mobile No.: +65 8298 9442
Contact Person: Tan Ai Li
Email: aili.tan@meritushotels.com
Website: www.meritushotels.com

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

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