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Ref : 27515
Event :Process Validation – Integrating ICH Q8, Q9 and Q10 into the Process Validation Process

Date :Thursday July 26th, 2018

Location :9106 Seven Locks Road, Bethesda, Maryland 20817
Bethesda, United States

Type :Congress - International audience

Accreditation :--


 

Further information

Objectives

ICH Q10, The Pharmaceutical Quality System, which was released to the international pharmaceutical industry in 2008, includes the concept of the product lifecycle. Since that time, the lifecycle approach has been applied to all aspects of pharmaceutical products and processes. ICH Q8, Pharmaceutical Development, and ICH Q9, Quality Risk Management, are closely integrated with ICH Q10. In 2011, the FDA issued its Guidance for Industry, Process Validation: General Principles and Practices. This guidance integrates quality system concepts from ICH Q8, ICH Q9 and ICH Q10 including lifecycle and identifies the three stages of the process validation lifecycle. The Europeans followed with a similar guidance for process validation including the lifecycle concept. This has now been incorporated into the revised Annex 15: Qualification and Validation of the EU GMPs. Worldwide, the pharmaceutical community is approaching process validation as a process control tool that is applied to pharmaceutical production processes throughout the life of the process and the product. It is now a challenge for the process validation team to integrate a lifecycle approach into the development and validation of new processes and the verification of the validation of old processes.
 

Speakers

Jerry Lanese
 

Location

Map and directions
Congress address :
9106 Seven Locks Road, Bethesda, Maryland 20817
Bethesda
United States
tel : 1-844-216-5230.
Map and directions

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Announcer





Compliance Training Panel
Description : Process capability and process performance indices are long-established metrics of a process ability to meet customer specifications. A Six Sigma process, in fact, has six process' standard deviations between the process nominal and the specification limits. If the process is centered on the nominal it will have two [...]

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Details

Process Validation – Integrating ICH Q8, Q9 and Q10 into the Process Validation Process Medicine
https://www.compliancetrainingpanel.com/webinar/topic?wb=mp00102
Professionals, Product development Process transfer Process validation
100 1 10
English

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