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OCT
05
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Project Management for FDA-Regulated Companiesthe 05/10/2010 Conference
in Online Event
This fda-Regulated webinar on Project Management will discuss and provide examples of most common project management tools and how to use it immediately to comply with fda and EU MDD regulations....
Similar events fda: events Medical Devices, events medical device
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OCT
15
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Preparing for and handling FDA Laboratory GMP inspectionsthe 15/10/2010 Conference online
This Laboratory GMP inspection webinar will discuss how to handle fda inspections by identifying the red flags, the target areas and knowing the steps of inspection.
Areas Covered in the Seminar:
Purpose of an fda inspection.
Inspection red flags.
Inspection Target Areas.
Preparing for an inspection.
Steps to follow during inspections.
How to respond to 483s.
Who Will...
Similar events fda: events laboratory analysis, events laboratory control
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JUN
12
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FDA Warning Letter Closeout Programthe 12/06/2012 Conference online
This fda warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from fda.
Why Should You Attend:
fda Commissioner Margaret Hamburg recently announced several new enforcement initiatives.
Who will benefit:
This seminar will give valuable help to fda regulated...
Similar events fda: events ing training, events Training
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JUN
27
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FDA's new enforcement initiative – Strategic Software Validation Planning for Executives and Managersthe 27/06/2012 Conference online
This Software Validation training webinar will discuss how to approach Strategic software Validation planning so as to satisfy fda by complying to new enforcement initiative by fda.
Why should you Attend:
fda has in place several enforcement initiatives. They are certain to impact your regulatory risk profile. How will you prepare for software quality, software...
Similar events fda: events software, events software systems
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JUN
28
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One and Half-day In-person Seminar: Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshopfrom 28/06/2012 to 29/06/2012 Seminar
in Grand Hyatt San Francisco
(San Francisco)
Knowing how to get your 510(k) application through fda quickly can save millions of dollars in unnecessary investment burn.
Mark DuVal, a national authority on the 510(k) program is in Silver Spring, Maryland at fda nearly twice a month negotiating 510(k)/IDE/PMA issues for his clients. He will teach you the basics and advanced knowledge of the 510(k) program. He will also provide...
Similar events fda: events professional documents., events document management
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SEP
05
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Validation and use of Excel spreadsheets in FDA regulated environmentsthe 05/09/2012 Conference online
This fda validation training will describe methods for planning and executing spreadsheet validations that satisfy fda requirements.
Who will benefit:
This seminar will give valuable help to fda regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include:
- System owners and personnel who...
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JUL
11
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GAMP® 5 as applied to FDA software validation - strategies to avoid warning lettersthe 11/07/2012 Conference online
This GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to fda software validation.
Why Should You Attend:
Many companies struggle with understanding what fda, MHRA, EU and other Ministries of Health want to see regarding software validation....
Similar events fda: events software development
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AUG
22
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The 6 Most Common Problems in FDA Software Validation & Verificationthe 22/08/2012 Conference online
This fda Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.
Who will benefit:
This seminar will give valuable help to fda regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include:
- System...
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APR
13
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Revisión de la Calidad Del Productofrom 13/04/2010 to 14/04/2010 Workshop
in IQS - Instituto Químico de Sarrià
(Barcelona)
Review of product quality is a workshop that will provide students information on the rules and requirements of the European GMP and fda. Discuss the advantages of the annual review of the product as a tool for quality improvement and present sagging statistics used in the annual review of the product. It targets Responsible for quality control, quality assurance and quality management,...
Similar events fda: events quality of life, events quality of care
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APR
20
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Estudios de Estabilidad: Norma Ichq1from 20/04/2010 to 22/04/2010 Workshop
in IQS - Instituto Químico de Sarrià
(Barcelona)
Stability Studies: Norma Ichq1 aims to give an overview of the stability studies and explain the guidelines of the European Pharmacopoeia, fda and the rules governing ICHQ1 accelerated stability studies and stability studies of long term. "Giving a practical methodology to conduct the studies according to the rules. -Explain the treatment and evaluation of the data using a case. It...
Similar events fda: events european, events screening europe
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