GMP and Regulatory Expectations for Early IND Products 2017

Start Date : November 13, 2017
End Date : November 14, 2017
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : john.robinson@globalcompliancepanel.com

Description







 


 


Course "GMP and Regulatory Expectations for Early IND Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


 


Overview:


 


This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.


 


Why should you attend:


 


Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have modified the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time some of the things that may appear to have changed, have not, and the pharmaceutical worker should be aware of this.


 


Who will benefit:


 



 


 


Agenda:


Day 1 Schedule


 


Lecture 1:


Very Early Stages



Lecture 2:


GLP requirements



Lecture 3:


Early Pre-IND Studies



Lecture 4:


Meetings and Preparing for the IND



 


Day 2 Schedule


 


Lecture 1:


GMPs for Phase 1 IND products



Lecture 2:


GMPs for Phase 1 continued



Lecture 3:


Requirements for Phase 2 INDs



Lecture 4:


Preparing for IND Meetings



 


 


Speaker


Dr. Steven Kuwahara


Founder & Principal, GXP Biotechnology, LLC



Dr. Steven Kuwahara, Ph.D. is the Founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.


 


 Location: Taipei, TaiwanDate:  November 13th & 14th, 2017 and Time: 9:00 AM to 6:00 PM


Venue: WILL BE ANNOUNCED SOON , Taipei, Taiwan


Price:


 


Price: $895.00 (Seminar Fee for One Delegate)


Register for 5 attendees   Price: $2,685.00   $4,475.00 You Save: $1,790.00 (40%)*


Register now and save $200. (Early Bird)


Until October 05, Early Bird Price: $895.00 From October 06 to November 11, Regular Price: $1,095.00


Register for 10 attendees   Price: $4,922.00  $8,950.00 You Save: $4,028.00 (45%)*


 


Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar


At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.


As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.


For More Information- https://www.globalcompliancepanel.com/control/sponsorship 


 


 


 


 


 




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Organized by

Organized by globalcompliancepanel

NetZealous DBA as GlobalCompliancePanel ,
NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Tel: Event Manager
Mobile: 800-447-9407
Email: john.robinson@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com


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