This course provides the attendee with an understanding of the USP Chapter <1226>. FDA 483s on the subject of Method Verification will be discussed.
Event Date:May-18-2010
Note:Discount available for 10% Please Contact us on (+1-650-620-3915).
FDA
Do your compendial methods comply with USP <1226>?
Submitted by admin@complianc... on Thu, 04/03/2010 - 06:43Evolving Regulatory expectation for Particulates in Biologics
Submitted by admin@complianc... on Thu, 04/03/2010 - 06:38This webinar addresses evolving regulatory requirements for particulates and the techniques suitable for testing and characterizing sub-visible particulates in therapeutic formulations.
Note:Discount available for 10% Please Contact us on (+1-650-620-3915).
cGMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products
Submitted by admin@complianc... on Thu, 04/03/2010 - 06:34This cGMP training will helps you in understanding systematic plan of evaluating cGMP applicable to the IND product cycle, the regulatory mandates (FDA, ICH, CHMP and the EU medicine agency), risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.
Note:Discount available for 10% Please Contact us on (+1-650-620-3915).
Overview of Drug Development
Submitted by mkeller on Tue, 02/03/2010 - 16:23Date(s) And Time(s):
Apr 12 2010 8:30AM - Apr 12 2010 4:45PM
Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
Overview:
Proven Tips to Identify and Develop Pharmaceutical Products
From Discovery Through Marketing Application
Utilizing Chemistry, Manufacturing & Control (CMC) in Drug Development
Submitted by mkeller on Tue, 02/03/2010 - 16:20Date(s) And Time(s):
Apr 8 2010 8:30AM - Apr 9 2010 4:30PM
Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
Overview:
Navigate the CMC Compliance Maze
Arm yourself with the tools to write or assemble CMC sections of regulatory submission, to prepare for CMC meetings with FDA, and to avoid non-compliance.
WHAT YOU WILL LEARN
Regulatory Affairs Part I: The IND Phase
Submitted by mkeller28 on Wed, 24/02/2010 - 14:06Date(s) And Time(s):
Mar 15 2010 8:30AM - Mar 17 2010 3:30PM
Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
Overview:
All You Need to know about IND Submissions in Only 3 Days
Regulatory Affairs Part I: The IND Phase
Submitted by mkeller28 on Wed, 24/02/2010 - 13:50Date(s) And Time(s):
Mar 15 2010 8:30AM - Mar 17 2010 3:30PM
Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
Overview:
All You Need to know about IND Submissions in Only 3 Days
Regulatory Affairs Part I: The IND Phase
Submitted by mkeller28 on Wed, 24/02/2010 - 13:46Date(s) And Time(s):
Mar 15 2010 8:30AM - Mar 17 2010 3:30PM
Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
Overview:
All You Need to know about IND Submissions in Only 3 Days
Cayman Chemicals gets FDA warning
Submitted by Anonymous on Fri, 19/02/2010 - 01:49The last gasp for a dying company? Seems the deranged leader has got himself a warning letter about becoming a pharma by the FDA. Watch out ladies Maxey Cosmetics wants to sell you their contaminated, untested eyelash growth remedy, Someone lock him up before he kills more people.
DIA and FDA Office of Women’s Health (OWH): Strategies for Ensuring Representation of Patient Demographics in Clinical Research for Regulatory Review
Submitted by mkeller28 on Mon, 15/02/2010 - 15:35http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?pr...
Date(s) And Time(s):
May 5 2010 8:00AM - May 6 2010 5:00PM
DIA and FDA Office of Women’s Health (OWH) Host First Recruitment and Retention Conference.