SOP Workshop: Workshop in a Book on Standard Operating Procedures for Biotechnology, Health Science, and Other Industries

Product Description
Failure to follow one’s own procedures is the single most-cited violation of the Good Manufacturing Practices (GMP) regulations. In this workshop in a book, Dr. Paul Sanghera, the best selling author of several books in science and technology, presents cohesive, concise, yet comprehensive introduction to the fundamentals of Standard Operating Procedures (SOPs) in context of Good Manufacturing Practices (GMP), quality assurance, and quality control. Those who can benefit from this book include students and professionals in biotechnology, health science, and other industries: especially those who are trying to meet the FDA regulations on SOPs. This is a general book for the beginners to develop a basic understanding about SOPs. Also the busy executives and managers will find this book useful for a quick introduction to SOPs. The material is presented in the format of lecture notes, which are self-contained, comprehensive within the scope of the book, and presented in an easy-to-follow logical learning sequence. All concepts are explained from scratch with enough examples and exercises. Example SOP templates are provided to put the concepts in practical context. Topics Include: *Introduction to SOPs *Effective SOPs *Producing Effective SOPs *Living with Approved SOPs: following, monitoring, and controlling SOPs *Process Based Approach to SOPs *Solutions to Self Test Exercises * Example SOP Templates *Glossary of terms

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Training Specialist in a Biotech QA department – RCE – Holly Springs, NC

for a Training Specialist on a ten month contract opportunity with a leading Biotech company in Holly Springs, NC, . Job # 142249
Duties;
Write training SOPs…

From CareerBuilder – 16 Mar 2010 10:20:38 GMT – job details – View all Holly Springs jobs

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BioScience Laboratory Opportunity (Biotech) at Baxter International (Cedar Rapids, IA)

Pharmaceutical, Pharma, Science, Biology, Chemistry, Biotech, Regular Full-time, Job Requirements, Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records. Good verbal communication and…

View full post on Biotech jobs | Simply Hired

Siena Biotech Selects the QUMAS Biotechnology Package as Its Regulatory Content Management Solution

JERSEY CITY, NJ–(Marketwire – January 5, 2010) – QUMAS, the leading provider of Compliance Solutions to highly regulated companies, today announced that Siena Biotech SpA has selected the QUMAS Biotechnology Package (based on the industry leading eDMS DocCompliance) to improve document control, reduce approval lifecycles of documents and SOPs, and to become eCTD ready. Siena Biotech SpA has also selected QUMAS ProcessCompliance to automate Change Control and Non-Conformance Management and drive efficiencies across both processes. Initially, Siena Biotech SpA will roll the QUMAS applications out to 30 users.

“With this Package, Siena Biotech SpA is gaining access to a world class document management solution, packaged to ensure low acquisition and implementation costs for biotechnology companies,” said Ken Hayward, CTO at QUMAS. “By harnessing the power of DocCompliance with pre-configured industry practices for R&D leading to eCTD readiness, Siena Biotech SpA will be up and running with this solution very quickly.”

Siena Biotech chose the QUMAS Solutions because of the built in best practices for biotechnology operations, which suited its IT department that did not have the bandwidth to spend months configuring systems. The QUMAS Quickstart approach means that the organization will be up and running in a short time frame, with a relatively low cost. According to Siena Biotech, the look and feel of the interface is great, and very user-friendly.

Goran Westerberg, head of Development Operations in Siena Biotech SpA commented: “We were in the market for a flexible and up-to-date system for document management and found QUMAS Solutions to be the ideal fit for our organization, allowing the system to grow with the portfolio of the Company.”

Federico Paoli, Siena Biotech’s head of IT, concluded that “QUMAS was able to quickly map our needs and provide a solution that fits our infrastructure.”

H@rlock, the QUMAS partner in Italy, has been instrumental in engaging Siena Biotech with QUMAS, in providing local representation and continue to represent QUMAS throughout the Italian market.

This announcement marks the beginning of a new area of business for QUMAS, extending its traditional tier one and two life sciences focus further across the sector to smaller organizations that require the same solutions, but at a lower cost and in an easy to implement format.

About QUMAS: QUMAS is the leader in Enterprise Regulatory Compliance Solutions with more than 250 global customer deployments and over 15 years of experience helping companies in highly regulated industries. For more information visit www.qumas.com

About Siena Biotech: Siena Biotech SpA is an innovative drug discovery company focused primarily on degenerative and proliferative diseases of the central nervous system with the aim of discovering new drugs for therapeutic intervention.

The company was established in 2000 by the Monte dei Paschi di Siena (MPS) Foundation, which is a non-profit, private institution. Since its inception, the company has grown rapidly to achieve the critical mass needed to compete successfully, and has developed a well-balanced and innovative project portfolio focused on the CNS diseases of Alzheimer’s and Huntington’s diseases and brain tumours. For more information visit www.sienabiotech.com