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EVENT DATES
May 2014
MoTuWeThFrSaSu
   1234
567891011
12131415161718
19202122232425
262728293031 
EXHIBITION HALL DATES
May 2014
MoTuWeThFrSaSu
   1234
567891011
12131415161718
19202122232425
262728293031 

Venue

Hyatt Regency Bethesda One Bethesda Metro Center 7400 Wisconsin Ave. Bethesda , Maryland 20814
Tel: (301) 657-1234
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2014 PDA Knowledge Management Workshop - Enabler For ICH Q8 - Q11, QRM And Continued Process Verification

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Overview

Do you understand Knowledge Management?  Have you found that when senior operators and managers retire some part of how things run smoothly is lost?  Do deviations take a long time to find the root cause?  Does the organization collect hundreds of thousands of data points but you still don’t understand the process? This workshop will cover each of these questions and be directly targeted to understanding the types of systems that need to be put into place to capture and manage knowledge.

Knowledge management is defined in ICH Q10, Pharmaceutical Quality System as a systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components. Health authorities expect that complex information is accurately and consistently captured, managed, and shared during the product life cycle.  Knowledge management is viewed by the authors of ICH Q10 as an enabler of the pharmaceutical quality system from product development to discontinuation.

Knowledge management facilitates a wide range of activities in the manufacturing environment. It supports quality risk management during risk assessment, when determining the impact on quality and probability of detection of an event. It helps to develop an appropriate control strategy, from defining critical quality attributes to justifying why process parameters are critical or not. Prior platform knowledge and process risk assessments support QbD approaches and guide process development. Design spaces are defined and justified using properly managed data and information.  

  • Business need: keep knowledge within the company when people leave (retirement or change of jobs); in today’s world even more important since job changes are so frequent and war for talent has become intense.
  • Productivity,  “LEAN” – first time right: designing strategy depends on prior knowledge
  • Innovation: based on prior knowledge

This is the workshop to attend if you want to treat knowledge as an important asset for your organization, and how to implement a program to capture and manage knowledge to achieve its full benefit. 

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