Effective Quality Risk Management & CAPA
A GMP Inspector’s Perspective on Compliance

מערכות איכות יעילות לניהול סיכונים, כולל CAPA


Minimize Failure, Maximize Profits and Effectively Meet the Latest GMP Compliance Requirements from Inspection Agencies World-wide. Total Compliance to EU GMPs Annex 20 – “Quality Risk Management”

תאריך: 27 מאי 2013
מיקום הקורס: מלון דן פנורמה תל אביב
קטגוריה: איכות , מומחים מחו"ל
מידע כללי
משך הפעילות: יום לימודים מלא
שעות:  09:00-17:00
עלות: 2,150 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 13387
שפת הקורס: אנגלית
על הקורס

A sound effective “Quality Risk Management” (QRM) program enhances productivity and profitability of pharmaceutical manufacturing and testing operations and assures patient safety. This course evaluates the requirements of the EU GMPs on Quality Risk Management and CAPA (Corrective Actions and preventive Actions) from a GMP Inspector’s perspective. The course examines how to effectively implement QRM requirements, and evaluates how and why Good Manufacturing Practice (GMP) regulatory inspection agencies world-wide have zeroed in on Quality Risk Management as the premier means to assure GMP compliance, and enhance patient safety. Companies that have implemented sound QRM practices have dramatically enhanced their profitability by implementing QRM’s “do it right the first time” practices as well as benefited from a reduced frequency of GMP inspections by authorities. This course provides examples of companies doing it right and companies getting it very wrong

קהל היעד

This course is designed for all staff concerned, and involved with, the quality of pharmaceutical products; especially Senior Corporate Management (Director and VP level); and Quality Assurance, Production, Quality Control Laboratories and Regulatory Affairs management staff

Effective Quality Risk Management & CAPA
A GMP Inspector’s Perspective on Compliance
התועלת שתופק

At the end of the course you will:

  • understand why all GMP inspection agencies world-wide are demanding pharmaceutical companies implement effective Quality Risk Management practices, and its implication to your company
  • learn the top 10 issues associated with proper Quality Risk Management implementation
  • understand the A-Z of QRM implementation
  • be able to implement a sound cost-effective QRM and Corrective and Preventive Action (CAPA) program in your facility
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

Course Overview

GMP inspectors from regulatory agencies (EMA, FDA, MHRA and others world-wide) have long recognized that during a 5 day inspection performed typically once every 2 - 3 years they can maximally view 5% of all activities in a pharmaceutical company. Faced with the long list of GMP deficiencies that are cited after this minimal inspection as well as the numerous reasons arising from product recalls, GMP inspectorates are concerned about how the 95% of operations that they do not see impact patient safety. Based on this fear, regulatory agencies world-wide under the auspices of the International Conference on Harmonization (ICH) have promulgated and implemented guidelines (ICH-Q9) on how pharmaceutical companies are expected to handle “Quality Risk Management” (QRM), and these expectations form a core part of GMPs.

Implemented in Europe by the EMA as Annex 20 of the EU GMPs, QRM requires all pharmaceutical and API companies to have systems in place to prevent failure in production and testing processes; and when failure occurs (out-of-specification results, process deviations, complaints, etc.) to perform root cause analysis to investigate the failure and prevent its recurrence – an investigative process termed CAPA (Corrective Action and Preventive Action). During the past 4 years the main GMP observations cited by GMP inspectorates world-wide have focused on company’s lack of effective QRM and CAPA systems.

This course provides a sound grounding in QRM and CAPA, what the concepts are, how to implement a sound program and gaining the best output from QRM and CAPA programs to increase productivity, profitability and patient safety.

Course Outline

  • What is Quality?
    • Quality Systems, Components of Quality Systems, Quality Processes, ICH-Q9
  • Quality Risk Management
    • What is Risk, Identifying Risk, Mitigating Risk
  • •    Root Cause Analysis
    • How to perform effective Root Cause Analysis; How to know when you have identified the Root Cause; What to do when you cannot find the Root Cause?
  • Regulatory Issues
    • What do the regulations and guidelines say; what do the authorities expect from you?
    • What specifically does a GMP inspector want to see in your QRM system?
  • Quality Risk Management and CAPA
    • Taking effective Corrective and Preventive Actions (CAPA); How do you know when your CAPA plans and practices are effective, or even when you’ve done too much?
  • Performing Proper Investigations
    • Out-of-Specification Investigations, Deviation Investigations, Complaint investigations – How to properly perform these investigations, and the benefits to be derived from proper investigations
  • Tools to Effect CAPA Fixes
    • Brainstorming, Ishikawa (Fishbone) Diagrams, Pareto Analyses, Process Mapping, Trend Charts, Why-Why Analysis, Forced Field Analysis, 6-Sigma Problem Solving – and putting it all coherently together
  • Risk Pre-Emption, Risk Reduction
    • Failure Mode Effect Analysis (FMEA), Fault Tree Analysis (FTA), Hazard Analysis Critical Control Points (HACCP)

Case Studies: Learn from Others: Examples of pharmaceutical companies getting it right; and companies getting it wrong – totally wrong – and costing them a fortune

אודות המרצה

Mr. Michael Anisfeld

is senior consultant for Globepharm Consulting specializing in GMP/Quality activities for the healthcare manufacturing industries. In his current position he numbers among his clients United Nations Agencies, national regulatory agencies (including the US-FDA) and more than 200 pharmaceutical, medical device, biotechnology and bulk pharmaceutical companies in North America, Europe and Asia.

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