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Parameter Generation & Control, Inc. Complete Pharmaceutical Stability Solution including stability chambers and rooms, stability validation services, and "off-site" stability storage services.
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Beckloff Associates Founded in 1976, Beckloff Associates, Inc. assists companies with worldwide development of pharmaceutical, biotechnology, and medical device products through regulatory and product development planning, regulatory...
Drug Development Consulting Support
Since 1976, Beckloff Associates has been a full-service pharmaceutical research and development consulting firm that specializes in helping pharmaceutical,...
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Ofni Systems Ofni Systems’ Electronic Data Management software reliably and efficiently automates complex record generation. FDA regulated industries, including pharmaceuticals, bioscience, medical devices and clinical trials, utilize...
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GeneEd For corporations seeking to train anywhere from ten to thousands of users, annually, GeneEd offers the flexibility of 2 distinguished Multiple User Training Programs. These programs provide a convenient solution to...
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CSS Informatics CSS Informatics provides expert pharmaceutical software consulting services and leading-edge software to pharmaceutical, biotechnology, medical device and CRO companies to improve the quality and efficiency of clinical...
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Osellus Osellus is a leading provider of enterprise-class software process solutions that help development organizations maximize the effectiveness of their end-to-end processes. The company's standards-based software and...
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Pharma-Sys Our first responsibility is to our Customers - to help them protect lives and to help them comply with those government regulations that are in place to protect lives. In so doing, we must provide compliance services of...
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More
CFR Part 11 Training
Research Library
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Parameter Generation & Control, Inc.
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On the surface, providing a specified humidity and temperature for stability testing may appear easier to achieve than the 5% RH and 2C ICH guidelines would seem to indicate. The ability to control humidity at 2% does not mean that you are safely within the 5% RH tolerance dictated by ICH.
The ability to produce a recording, display, or printout that is within a specified tolerance may not be a ...
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Clinical Research Training Center
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The CRTC is the only training provider, that incorporates in its program and price structure a full scale job placement support and coaching till hire and provides services, which covers all the needs of the aspiring CRA and CRC
- Rapid access (in 3-6 months) to a very well paid, but almost unknown career
opportunity with chronic shortage of trained staff
- Personalized on-line training, ...
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Pilgrim Software, Inc
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White Paper Regulation 21 CFR Part 210-211
© 2006 Pilgrim Software, Inc. All Rights Reserved
The demand for healthcare products is ever increasing as the landscape of modern society evolves. These trends are reshaping the Pharmaceutical and Biologics industries. With the demand for products, comes the concern among pharma-bio manufacturers for regulatory scrutiny. Non-compliance is fiscally ...
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Veriteq, a Vaisala company
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The 21 CFR Part 11 rule states that the FDA view is that the risks of falsification, misinterpretation, and change (without leaving evidence) within the GMP environment are higher with electronic records than paper records, and therefore specific controls are required.
The Veriteq validatable data logging system is a “hybrid” system that employs the use of both electronic records and signed ...
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Veriteq, a Vaisala company
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The 21 CFR Part 11 rule states that the FDA view is that the risks of falsification, misinterpretation, and change (without leaving evidence) within the GMP environment are higher with electronic records than paper records, and therefore specific controls are required.
The Veriteq validatable data logging system is a “hybrid” system that employs the use of both electronic records and signed ...
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CFR Part 11 Training
Video
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