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Key deadlines

Conference starts:

2018-03-22

Website

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Conference 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
Email: support@compliance4All.com