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JVT new features include:
Validation Learning Center: Focuses on basic validation information, coordinated by Editor Paul Pluta
Cleaning Validation: Addresses situations faced in cleaning and cleaning validation. Coordinated by Rizwan Sharnez of Amgen
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GXP new features include:
Engineering for Non-engineers: Engineering topics
Compliance Tools: Methods and techniques relevant to compliance Biotech Processes - Various unit operations in manufacturing biotechnology products
Training for Compliance: Key points for training
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Domestic
International |
Welcome to the fresh new world of the Journal of GXP Compliance and the Journal of Validation Technology!
We've created an exciting new look in compact, easier to manage journals, with stellar additions to our editorial board, new topical features, and more. We've taken reader suggestions under consideration, and have been working on improvements for several months. We invite you to join us for the unveiling!
The Institute of Validation Technology (IVT) has redesigned our journals with updated content that combines reader-favorite columns with expanded new columns, industry news, increased interactivity, and practical tools like sample charts, graphs, spreadsheets, and appendices available online for easy downloading.
Members of the journals' Editorial Advisory Boards (EABs) are recruited from expert industry practitioners and consultants who review submitted articles for accuracy and relevance. In 2008, the journals added industry expert Paul L. Pluta, Ph.D. to the editorial staff. Dr. Pluta's expertise will enhance editorial content with new insight and written contributions.
We invite you to submit your own experiences and opinions to help us keep our content fresh and relevant.
Both the Journal of GXP Compliance and the Journal of Validation Technology will feature the following new columns:
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Auditor Tales —Coordinated by Michael Anisfeld, senior consultant with Globepharm Consulting Inc., this column presents a discussion of actual problems encountered in compliance and validation. Mr. Anisfeld will also serve the journals as a guest commentary writer.
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Statistical Viewpoint — Focusing on basic statistical information for the industry everyman, this column is especially applicable to compliance and validation. Abbott Laboratories' David LeBlond coordinates this column, presenting statistical principles useful to practitioners in compliance and validation. While certain barriers to understanding statistical principals exist (complex mathematics, abstract ideas, required assumptions, etc.) this valuable resource presents statistical principles with those barriers in mind. Statistical concepts are explained in a meaningful way to help readers understand and apply statistical concepts to work situations.
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Global Regulatory Viewpoint — Regulatory information is discussed from a global perspective, useful to those who deal with pharmaceutical development, regulatory submissions involving chemistry, manufacturing and controls (CMC), validation, and compliance. In addition, it is a vehicle for publishing various approaches that define or contribute to best practices. By serving these functions, this column will enhance communication to and from regulators and industry so that regulatory expectations for the entire product lifecycle are clearly understood.
Note to readers:
Reader comments, questions, and suggestions are needed to help fulfill the objective of all columns, old or new. We invite questions on current columns or your suggestions for future discussion topics. Your help will ensure that all columns are useful, relevant and topical. Submit your comments, suggestions or manuscripts for publication to Coordinating Editor Susan Haigney: shaigney@advanstar.com.