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Environmental Monitoring
February 25-27, 2009
Hilton San Diego, Mission Bay, San Diego, CA
Developing, Deploying and Managing Best Practices for Environmental Monitoring In the Life Sciences Industry
Risk Management in Environmental Monitoring - Using Risk Assessment to Develop a Lean, Yet Effective, Environmental Monitoring Program. Arm yourself with valuable new tools to develop the optimal EM program from an array of case studies, interactive exercises and take home tool kits.
Early Bird Special! Register by December 24, 2008!
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Preformulation & Formulation Strategies for Pharmaceutical Products
January 27-28, 2009
Philadelphia, PA
This enlightening conference format features, in chronological order, all of
the necessary steps you should consider in preformulation and formulations strategies
and how these new strategies can accelerate drug process development. A special
emphasis is placed on the application of current Quality-by-Design principles.
Early Bird Special! Register by November 25, 2008!
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event brochure
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7th Annual Change Control
January 26-28, 2009
Marriott Courtyard Downtown, Philadelphia, PA
Developing, Deploying and Managing Best Practices for Change Control in the Life
Science Industry
This 7th Annual Event is a three-day conference bringing together change control
experts and regulatory representatives who will present their experiences in change
control process in pharmaceutical manufacturing. Participants will attend workshops
in a case-study format that will include topics such as documentation requirements,
configuration management, six sigma, validation, global regulations, post-monitoring
and much more!
Early Bird Special! Register by November 21, 2008
Download event brochure
Hurry for a 10% pre registration discount before 11/21/2008 !
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WEB SEMINAR CD: Cleaning & Cleaning Validation; An Overview
This web-seminar CD will present a general overview of the cleaning process for equipment and facilities in the pharmaceutical industry. The regulatory requirements for a cleaning SOP will be defined by reviewing several examples of FDA 483 notices of adverse findings given to companies in the industry.
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Web Seminar CD: Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11: With Clear Recommendations for Corrective and Preventive Actions
The new Part 11 regulation takes quite some time, but inspectors go out and focus inspections on computer systems and electronic-records for compliance with GMPs. Just in 2007/2008, there have more than 20 deviations related to computer system validation and Part 11compliance, some with disastrous consequences for inspected companies. Purchase this Web seminar CD and learn how to avoid such warning letters.
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JVT Article: A Step-by-Step Approach to Establishing a Method Validation Program
Journal of Validation Technology, August 2007, Vol. 13, No. 4, pages 317-328, Author: Cindy Green
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JVT Article: Choosing Choosing Wisely Wisely: The Benefits and How To of Doubling Sampling Plans for Attributes Testing
Journal of Validation Technology, August 2007, Vol. 13, No. 4, pages 312-316, Author: Alyssa Sloan
Choosing the best sampling plan for process validation and design verification testing is aided by knowledge of all of the options. An alternative and often more efficient option to the single attributes sampling plan is the double sampling plan for attributes testing.
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JVT Article: Application of Probability of Passing Multiple Stage Tests in Benchmarking and Validation of Processes
Journal of Validation Technology, August 2007, Vol. 13, No. 4, pages 286-311, Author: Pramote Cholayudth
This article will discuss the scientific aspect of the last QA principle mentioned above and describe how to demonstrate the probability of meeting the product specifications, for multiple stage tests, for future quality control (QC) samples using process optimization or validation test results.
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GXP Article: Achieving Risk Management for FDA Compliance Using ISO 14971
Journal of GXP Compliance, July 2007, Vol. 11, No. 4, pages 22-29, Author: Victoria Lander
Risk Management is a way to put safe products on the market and to ensure that any unsafe products that do reach the market are promptly identified and efficiently corrected.
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WEB SEMINAR CD Series: Advanced Topics in LC Method Validation
This 6 CD Series collection is presented by Dr. Michael Swartz will explore advanced topics including instrument qualification, robustness, method transfer, investigating out of specification results and adopting new technology. This seminar is aimed at Directors, Lab Managers, and Practicing Chemists in regulated laboratories responsible for designing or implementing method validation protocols with an LC focus.
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WEB SEMINAR CD Series: Validation Basics A-Z: Planning, Implementing & Maintaining
This is a 5 CD collection with our expert presenter Dr. Gamal Amer
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WEB SEMINAR CD: cGMP Informatics - IT Infrastructure Design for 21st Century Pharmaceutical Quality Control and Quality Assurance Operations
This web presentation will outline a new three tiered IT infrastructure for cGMP quality operations. Key to this structure is the implementation of a "thin LIMS" coupled with a GMP Electronic Notebook System. At this presentation attendees will learn. . .
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The Cleaning Validation Toolkit
8 titles included: The discipline of Cleaning Validation is as individual as process validation, but the methods, techniques and risks are almost identical in all kinds of pharmaceutical manufacture.
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Change Control Combo SPECIAL OFFER
SPECIAL EDITION - Change Control Implementation AND A Practical Guide to Change Control System Managememt
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Handbook to Laboratory Best Practices, Training and Facing Challenges
There are some who still believe (or still want to believe) that there are no regulations that apply to “Research”. This simply is not true.
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Handbook to GMP Training, Compliance & Risk Management Solutions: A European Perspective
This handbook highlights the need for patient focused & value adding qualification, validation & change control programmes for manufacturing and regulatory which are cost effective & in line with current regulatory requirements.
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FDA Main Toolkit
This Toolkit includes: Special Edition: cGMP Training, Special Edition: cGMP Training II, A Pocket Guide to cGMP Sampling, Web Seminar CD: Mock FDA Inspection and Web Seminar CD: Using FDA Warning Letter Trends to Create a Proactive Compliance Environment
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FDA Print Toolkit
This Toolkit includes: Special Edition: cGMP Training, Special Edition: cGMP Training II and A Pocket Guide to cGMP Sampling
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Medical Device Design Control Program
The Medical Device Design Control Program is a suite of documents that collectively establishes a comprehensive Product Development Program (PDP). The Suite consists of a set of twenty-five (25) inter-related standard operating procedures, templates and forms ready for customization.
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SOP Library
The SOP Library provides you with SOP templates in GCP, GMP and GLP documents. From FDA Inspections of Clinical Sites to Quality Control.
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Process Validation Combo
The Special Edition: Conducting Audits, Corrective and Preventive Action and Process Validation. Define, Document and Implement -- These three titles assist in establishing documented evidence and provide vital information on planning, implementation, meeting and exceeding required actions under Process Validation, Corrective & Preventive Action as well as Audits and Gap Assesments
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Cleaning Validation Handbook
The discipline of Cleaning Validation is as individual as process validation, but the methods, techniques and risks are almost identical in all kinds of pharmaceutical manufacture.
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DOMESTIC: Journal of GXP Compliance Subscription
The Journal of GXP Compliance is industry's only peer-reviewed Journal exclusively dedicated to providing practical information on: Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
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DOMESTIC: JVT Subscription
Journal of Validation Technology
The only peer-reviewed Industry journals exclusively dedicated to providing practical approaches for implementing compliance practices and conducting effective validations.
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