Drumbeat Dimensions, Inc. Sitemap
Drumbeat Dimensions Inc. is a validation and compliance
management consulting company providing tools and services for assessing
and enhancing Quality Management Systems in the pharmaceutical industry.
Company Information
At the start of each year, many people make resolutions aimed at
improving something about themselves. Pharmaceutical companies should
follow a similar approach to ensure that they minimize potential risks
of non-compliance. An annual assessment of your quality system is an
excellent way to avoid non-compliance surprises.
Drumbeat Dimensions Inc. is a validation and compliance
management consulting company providing tools and services for assessing
and enhancing Quality Management Systems in the pharmaceutical industry.
Tim Fields, President of Drumbeat Dimensions, Inc.,
has over 25 years of experience in the pharmaceutical industry
including 13 years with Pfizer where he was responsible for
organizing and managing the...
The DRUMBEAT® method is based upon a series of concepts
(DRUMBEAT® concepts) developed in 1977 by the late Ken Chapman to address the many policies and procedures called for by the new, then-pending cGMP regulations.
Drumbeat Dimensions was incorporated February 1, 1995, to answer the need of the health care industry to organize and upgrade its
GMP-related policy and SOP management systems.
Drumbeat Dimensions, Inc. provides links to companies and
organizations that provide beneficial services to the pharmaceutical
industry.
Find out where to meet a
Drumbeat Dimensions, Inc. representative at an industry
conference and get daily pharmaceutical industry news updates.
A document frequently referred to is the SOP (Standard Operating Procedure). The term SOP is somewhat ambiguous, in that various people and groups use different interpretations. The brief discussion about document classification that follows is intended to help clarify
Drumbeat Dimensions, Inc. use of the term.
Drumbeat Dimensions, Inc. Services
Drumbeat Dimensions Inc.'s audits are conducted by experienced industry professionals using a comprehensive systems-based approach to identify and reduce potential regulatory risks.
Drumbeat Dimensions, Inc. can help you to structure a management system by working with you to develop
Quality Policy and Procedure Guidelines (QPPGs) that define the quality standards for production and control of pharmaceutical drug products.
Using DRUMBEAT®-based tools, the knowledgeable professionals at
Drumbeat Dimensions Inc. can quickly and efficiently analyze and classify procedures, and provide Risk Analysis Profiles to client management.
The experienced professionals at Drumbeat Dimensions Inc. work in partnership with the client in the development
of
Validation Plans,
Protocols,
Reports, and
Management of Validation Documentation
Drumbeat Dimensions Inc.'s Training Professionals can provide training on a variety of
cGxP topics focused on ensuring that client personnel are adequately trained for their job function.
Contact
Drumbeat Dimensions Inc. to schedule a customized
training session at your company.
DRUMBEAT® Products
Dynamic DRUMBEAT® for Pharmaceuticals is an electronic set of DRUMBEAT® tools that enables you
to rapidly identify risks of regulatory non-compliance, search and compare SOPs across multiple plant sites, and against worldwide regulatory requirements,
organize, optimize, and manage SOPs, facilitate strategic audit planning and reporting,
simplify development of comprehensive Good Manufacturing Practice (GMP) Training Programs,
and expedite development of a Quality Management System
Dynamic DRUMBEAT® for Pharmaceuticals Tools
Find explanations of the Tools included in
Dynamic DRUMBEAT® for Pharmaceuticals.
Dynamic DRUMBEAT® for Pharmaceuticals FAQ's
Find the answers to some Frequently Asked Questions about
Dynamic DRUMBEAT® for Pharmaceuticals.
Dynamic DRUMBEAT® for Pharmaceuticals Demo
View a slide show demo of Dynamic DRUMBEAT® for
Pharmaceuticals. Drumbeat Dimensions, Inc. recommends a high speed Internet connection to view this slide show.
Dynamic DRUMBEAT® for Pharmaceuticals Case Studies
Real life examples of the DRUMBEAT® Method and Dynamic DRUMBEAT® for
Pharmaceuticals in action.
Dynamic DRUMBEAT® for Pharmaceuticals User
Guide
View the Dynamic DRUMBEAT® for Pharmaceuticals User Guide in your
browser. Requires Adobe® Acrobat® Reader™
Dynamic DRUMBEAT® for Pharmaceutical Clinical Trial Supplies is designed primarily for those who produce pharmaceutical Clinical Trial Supplies, and secondarily for those who use Clinical Trial Supplies in the execution of human clinical trials.
Regulatory requirements for pharmaceutical clinical trial supplies differ from regulatory requirements for corresponding commercial drug products, especially in the early stages of clinical research (for example, Phase I and early Phase II.) As Phases III and IV are reached, the differences become fewer and more clearly defined. Although
Dynamic DRUMBEAT® for Pharmaceutical Clinical Trial Supplies addresses clinical trial supplies in Phases I through IV,
Dynamic DRUMBEAT® for Pharmaceutical Clinical Trial Supplies was developed chiefly for preparation of clinical trial supplies in the advanced phases of clinical research in the US. Regulations in most parts of the world resemble those in the US.
Find explanations of the Tools included in Dynamic DRUMBEAT® for Pharmaceutical Clinical Trial
Supplies.
View a slide show demo of Dynamic DRUMBEAT® for Pharmaceutical Clinical Trial
Supplies. Drumbeat Dimensions, Inc. recommends a high speed Internet connection to view this slide show.
Real life examples of the DRUMBEAT® Method and Dynamic
DRUMBEAT® for Pharmaceutical Clinical Trial Supplies in action.
View the Dynamic DRUMBEAT® for Pharmaceutical Clinical Trial Supplies User Guide in your
browser. Requires Adobe® Acrobat® Reader™
Other Areas of Interest
Learn how Drumbeat Dimensions, Inc. handles the personal
information you submit.
Easy-to-use form to order DRUMBEAT® Products and Services.
Various methods to submit questions or ask for information about Drumbeat
Dimensions, Inc. and its Products and Services.
Find the definitions to some of the more frequently used words and
phrases in DRUMBEAT® Products.
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