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JUL
09
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Biosimilars - a Regulatory Overview and Market Reviewthe 09/07/2012 Workshop
in Central London
(London)
Biosimilars have attracted a great deal of interest recently and are seen by some as the new generic frontier. This masterclass will look at the regulatory barriers to entry as well as what has actually occurred in markets where Biosimilars have been launched. The programme also includes a look into what the future might bring in terms of a US Biosimilars pathway and competition for the high price...
Similar events drug reps: events market research, events bio-medical
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MAY
31
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Risk-Based Validation Equipment Validationthe 31/05/2012 Conference online
This training will provide a practical methodology for creating and applying Risk-Based Equipment Validation. It will show an example of how this process may be integrated into a facility Master Validation Plan.
Why Should You Attend:
In installing equipment, how much validation is enough? How much is too much? Risk-Based Validation establishes rules for what is appropriate and is the...
Similar events drug reps: events database system, events database design
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JUN
07
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Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environmentfrom 07/06/2012 to 08/06/2012 Conference
in Hyatt Regency Columbus
This 2-day on-site Course will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan and South Korea. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in both countries, the importance of partner selection and the cultural knowledge...
Similar events drug reps: events clinical trials, events clinical operations
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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 Pharmaceutical, Medical...
Similar events drug reps: events ing training, events fda
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JUN
19
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Reduce COTS Software Validation using the risk-based approachthe 19/06/2012 Conference online
Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.
Why Should You Attend:
This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system...
Similar events drug reps: events software, events Software Development
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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 validation and 21 CFR part 11...
Similar events drug reps: events software developers, events software systems
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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 drug reps: events software development
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AUG
08
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Spreadsheet Validation: Understanding and satisfying FDA requirementsthe 08/08/2012 Conference online
This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.
Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data.
...
Similar events drug reps: events technical drawing, events technical translation
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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 owners -...
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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 create or use ...
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