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Langue du site : Français - English
Réf : 26635
Evènement :GMPs for Active Pharmaceutical Ingredients

Date :Mercredi 21 Février 2018

Lieu :9106 Seven Locks Road, Bethesda, Maryland 20817
Bethesda, Maryland, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Objectives

Description :
In this webinar we will discuss the regulatory expectations that apply to the production and control of active pharmaceutical ingredients. The discussion will start with the introduction of ICH Q7, the internationally accepted GMP for APIs, and discuss how this is supplemented by contemporary guidance such as ICH Q10, the Pharmaceutical Quality System, ICH Q8, Pharmaceutical Development, ICH Q9 Quality Risk Management and ICH Q11, Development and Manufacture of Drug Substances. The impact of new FDA guidance on Process Validation and Quality Metrics will also be considered.

 

Speakers

Name: Jerry Lanese

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.

Lieu

Plan et itinéraire
Adresse de la conférence :
9106 Seven Locks Road, Bethesda, Maryland 20817
Bethesda
Maryland, États-Unis
Tél : 1-844-216-5230.
Plan et itinéraire

Renseignements

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Annonceur





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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Précisions

GMPs for Active Pharmaceutical Ingredients Pharmacie - Paramédical
http://bit.ly/2btyshq wednesday, february 21, 2018 at 13:00 hrs (est)
Professionnels, In the API manufacturer Senior management Site managers Materials Production Quality Control Quality Assurance Reviewer Auditor In the Drug Product Manufacturer Purchasing agents Quality Assurance Quality Control Quality auditor
50 1 50
English

Divers

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