Ajouter un événement
Annoncer / Référencer
SPECIALITES MEDICALES ...

GMP for Phase I Investigational Drug Products 2018

Du Jeudi 22 Mars 2018 au Jeudi 22 Mars 2018 à CA
A partir de: 10:00
Secteurs concernés: Equipement médical -Soins Infirmiers -
DESCRIPTION
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

PUBLIC, SECTEURS, ACCREDITATION
Accréditations : 0
Public concerné: Professionnel
Audience: Internationnale
Visiteurs/Participants: 50
Conférenciers: 1
Exposants: n.r
Type d'événement: Conférences en ligne
Secteur principal: SOINS INFIRMIERS
Secteurs concernés: Equipement médical -Soins Infirmiers -
ORGANISATEUR / ANNONCEUR

COMPLIANCE4ALL
161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congrès, formations ou conférences médicales REF #28-7834
GMP for Phase I Investigational Drug Products 2018
Publié sur congres-medical.com le : 2018-02-01 11:04:56
Congrès, formations ou conférences médicales en SOINS INFIRMIERS
Affiche / Visuel
RESERVATIONS HOTELS: CA
Obtenez les meilleures offres
sur les hôtels!
près de Online

Recherche d'hôtels

Date d'arrivée

Date de départ

VOTEZ
Evaluez cette annonce
PREPAREZ VOTRE VOYAGE
Liens extérieurs sponsorisés
;
Plus d'information sur le HONcode