GMP for Phase I Investigational Drug Products 2018
ENDED
Training by
Compliance4All
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On-Site
/ Training
USD 150.00
Details
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
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
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
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
Outline
Speaker/s
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.
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.
Special Offer
One Dial-in One Attendee
Price: $150.00
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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 has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.