Resource Center: Project Management
Information Technology Project Management Resources
General Project Management Resources
Below are links to a number of web resources for project management, pharmaceutical and biotech information, and technology information useful to IT project managers in the life sciences industry.
Provides processes, templates, articles and discussions to aid in managing information technology projects.
Construx's Steve McConnell is a well-known pragmatic author and software process improvement advocate. Construx offers training, advice, and numerous software engineering resources.
Software Productivity Center
Provides a number of project management software development process improvement resources and self assessment tools.
Provides processes, tool reviews, articles, discussions and other research for project management and software development professionals.
Includes research, news, discussions and best practices for project managers.
The Pharmaceutical Institute offers books and educational materials for the pharmaceutical and biotech industry professionals; useful for project managers looking to augment their domain knowledge.
Focuses on software process improvement with an emphasis on the requirements phase of the software development life cycle. This site includes books, templates, white papers, and training materials.
Has compiled an excellent software development book list, which includes books specific to validation and SOP authoring for regulated pharmaceutical applications.
Provides various project management resources including templates, links and articles.
Templates and Methodologies
Below is a selection of web sites that provide project methodologies and templates in a wide price range some are free.
VECS is looking for one or more web sites that provide templates specific to computer system validation (e.g., Validation Plan and Report, Installation/Operational Qualification, SOPs). If you know of a resource please
e-mail us at email@example.com.
Project Management News
Pharmaceutical Industry and Project Management Associations
Project Management Institute
"PMI stands as a global leader in the development of standards for the practice of project management. Our premiere standards document, A Guide to the Project Management Body of Knowledge (PMBOK® Guide), is recognized throughout the world as a standard for managing projects in today's marketplace." "PMI's Project Management Professional (PMP®) certification is the preeminent professional credential for individuals associated with project management." The site includes a variety of project management resources, papers, and publications.
PMI Pharmaceutical Special Interest Group
"We provide a unique opportunity for project management professionals in the pharmaceutical, bio-tech, contract research, and medical device industries to network with and learn from one another."
PMI Delaware Valley Chapter
The Delaware Valley Chapter of the PMI serves the Greater Philadelphia Area, South Jersey, Delaware and Northern Maryland.
DIA (Drug Information Association)
"DIA is a professional association of approximately 20,000 members worldwide who are involved in the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products." DIA offers a number of seminars, webinars, training, and networking opportunities.
Society for Clinical Data Management
"The Society for Clinical Data Management (SCDM) is a non-profit professional society founded to advance the discipline of Clinical Data Management."
Association for Clinical Research Professionals
"ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology, and medical device industries, as well as those in hospital, academic medical centers, and physician office settings."
Institute for Validation Technology
"As publisher of the Journal of Validation Technology® and the Journal of GXP Compliance®, we are dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries."
Other Tools Used by VECS
Below are other tools that VECS has successfully used.
news from InformationWeek.
Articles, Presentations, and Webcasts
Below are a few recently archived articles that discuss current trends in project management.
Following are some periodicals which focus on project management, the pharmaceutical industry, and information technology.
- Applied Clinical Trials - The Global Guide to Clinical Trials Management
- BioPharm International - The Applied Technologies of Biopharmaceutical Development·
- Pharmaceutical Executive - A Global Business and Marketing Publication
- Pharmaceutical Technology
PMI Pharmaceutical Special Interest Group regularly offers project management webinars - Click on Webinars. PharmaSIG membership is required.
Upcoming IT Management and Health and Life Sciences webinars from BetterManagement.com
Below is a list of recurring project management conferences:
Following is a small subset of frequently referenced FDA guidance.
General Principles of Software Validation - January, 2002
This document provides guidance for development of validated software (i.e. software that is fit for its intended use).
Computerized Systems Used in Clinical Trials - April, 1999
This document provides guidance for development...
Draft Guidance - Computerized Systems Used in Clinical Trials - September, 2004
This document provides guidance for development...
Electronic Records and Electronic Signatures (21 CFR Part 11)
The following describe the FDA’s rule for implementing electronic records and electronic signatures and provide guidance for applying the rule known as 21 CFR Part 11.
Glossary of Computerized System and Software Development Terminology
This document is referenced in many of the FDA’s guidance documents.
A list of all the FDA’s current guidance documents is available here.
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