Pack of TEN: Best Selling Pharma Webinars by GlobalCompliancePanel
Actual Price: $2950.00
Your Price: $1095.00
GMP Expectations for Products Used in Early Phase
FDA issued a guidance document covering GMP requirements for
Phase 1 products. These guidelines remove some of the problems
that are encountered with early phase products and are in addition
to those that cover the CMC sections for IND submissions at Phase
Steven S Kuwahara
Founder & Principal, GXP
GMP for Phase 1 Products
This presentation will cover the contents of the guidance that was Steven S. Kuwahara, Ph.D. is the
given. founder and Principal of GXP
BioTechnology LLC, a consulting firm
FDA has issued as rule that relieves Phase 1 products from that works in the areas covered by
complying with the GMP given in 21 CFR 211. the GLP and GMP of drugs, biologics,
and nutraceuticals. ..more
Transfer of Analytical Methods and Procedures: FDA
Dr. Ludwig Huber
Requirements and Strategies and Tools for
Chief Advisor - Global FDA
When validated methods are transferred between laboratories and
sites, their validated state should be maintained to ensure the
same reliable results in the receiving laboratory. Ludwig Huber, Ph.D., is Director of
Labcompliance and Chief Advisor for
Understanding and Implementing USP <1058> global FDA compliance at Agilent
Analytical Instrument Qualification Technologies. ..more
Analytical instruments should be qualified to demonstrate suitability
for the intended use. Despite the fact that instrument qualification Kerry Paul Potter
is nothing new and companies spend a lot of time, it is a frequently President, Summit
cited deviation in FDA inspectional observations and warning
Kerry gained his pharmaceutical
manufacturing experience during his
Understanding the New USP Chapter 1224 for Transfer 28-year career with Merck. His
of Analytical Methods career spanned the areas of Quality
When validated methods are transferred between laboratories and Operations, Audits & Inspections,
sites, their validated state should be maintained to ensure the Laboratory, Human Resources, and
same reliable results in the receiving laboratory. Learning & Development. ..more
Calibration and Qualification in Analytical Laboratories
Laboratory equipment should be calibrated and/or qualified to
Your Necessity is our Priority
demonstrate suitability for the intended use.
Laboratory systems including equipment are amongst key targets
of FDA inspections.
Good Documentation Practices for GMP Operations
Whether you work in production or in a laboratory or if you conduct
investigations or finalize product release, sound data and
information is essential to success and compliance. .
Learning from Recent FDA Warning Letters Related to
Computer Validation and Part 11 - Prepare Yourself for
the upcoming FDA Part 11 Inspections
On July 8, 2010, the FDA announced to soon conduct a series of
inspections related to 21 CFR Part 11.
FDA made it very clear that the focus of the inspections will on most
critical issues the industry had with Part 11 in the past.
Good Laboratory Practice Regulations - Introduction
and Strategies for Implementation
Complying with GLP regulations can increase the cost of a
laboratory up to 30%. Companies or employees either don't know
exactly what GLP really means, what procedures are required and
how to implement GLP regulations.
Understanding Analytical Test Results: Comparing Two
Sets of Data
The class will cover the understanding the properties of single test
results and how they may be compared.
There are many problems that arise from a misunderstanding of the
properties of single data sets and the problems are compounded
when data sets are compared.
Click here to buy the webinar pack
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
1000 N West Street Suite,
1200 Wilmington DE 19801
Phone: 800-447-9407 or
Fax your PO to: 302-288-6884
If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe