Votre événement devrait être ici ! Pour référencer, gérer, promouvoir... Pour s'informer ou se former ... Inscriptions en ligne

Langue du site : Français - English
Réf : 26437
Evènement :GMP for Phase I Investigational Drug Products 2018

Date :Jeudi 22 Mars 2018

Lieu :En ligne (Internet, Visioconférence, ...)

Type :Formation - Audience Internationale

Accréditation :--


 

Informations

Overview:
Phase I clinical trials are the first time that investigational new drugs are introduced into human subjects and, although it is very, very important for all drugs to be manufactured using GMPs, it is probably more important than at any other time during the lifecycle of the product, that a product be safe whenever humans are being exposed to it for the first time.
 
Why should you Attend:
FDAs guidance document "Good Manufacturing Practice for Phase I Investigational Drug Products" applies to correct GMP requirements to drug products made for the purpose of using an investigational drug product on human subjects for the first time, during conduct of Phase I clinical trials, which can begin if your IND is not put on clinical hold in 30 days after receipt by the FDA.
 
Areas Covered in the Session:
Statutory and Regulatory Requirements
Personnel requirements
QC Functions
Facility and Equipment Requirements
Control of Components and Containers and Closures
Manufacturing and Records 
 
Who Will Benefit:
Senior Quality Managers, Quality VPs
Quality Associates or Specialists
Regulatory Management or Regulatory Specialists
Compliance Professionals
 
Speaker Profile:
Stephanie Cooke is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms.
 
Event Fee: One Dial-in One Attendee Price: US$150.00
 
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/control/w_product/~product_id=501683LIVE?channel=doctorama_Mar_2018_SEO

Renseignements

Pour accéder aux informations vous devez être connecté. Créer un compte est facile et gratuit!

Connexion à votre compte
S'inscrire sur Doctorama

Annonceur

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

Autres évènements de Compliance4All

Fiche de présentation de Compliance4All

Précisions

GMP for Phase I Investigational Drug Products 2018 Médecine - Pharmacie
--
Professionnels, Healthcare, Medical, Online Trainings, Safety courses
50 1 --
English

Divers

Pour plus d'informations sur GMP for Phase I Investigational Drug Products 2018, veuillez contacter Compliance4All

Pour afficher le site de l'annonceur, vous devez être connecté

Connexion à votre compte
S'inscrire sur Doctorama


Recommander cet évènement