• Reading the FDA Tea Leaves

    7 December, 2011 John Avellanet, Management Director, Cerulean Associates, LLC

    Adapted from Cerulean's regulatory intelligence monthly newsletter, SmarterCompliance™ (No. 48, Vol. 4, Iss. 12).

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  • Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean

    19 April, 2017 Mike Micklewright, President of QualityQuest Inc.

    This article originally appeared in "Quality Digest Daily," an electronic publication from Quality Digest (www.qualitydigest.com)."

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  • Things Change - Plan On It

    Denise Robitaille, RABQSA-certified lead assessor, ASQ-certified Quality Auditor and Fellow of the American Society for Quality

    This article was originally published by Quality Digest Magazine.

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  • Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program - Part 2

    6 October, 2010 Nancie E. Celini, GxP, Learning Program Lead

    In the previous article I discussed the use of the acronym "GxP" as well as regulations, a changing industry landscape and some suggestions for becoming a learning organization. In this article we will look at learning and why having a strategy, leadership and a comprehensive program is so important in our work and to our future success.

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  • Better Innovation for Product Development and Process Improvement

    19 April, 2017 Ellen Domb, Founding Editor of The TRIZ Journal and principal TRIZ consultant for the PQR Group, and Joe A. Miller, Biomedical Engineer and TRIZ consultant

    TRIZ is a problem-solving method based on logic and data, not intuition, which accelerates, broadens, and deepens a project team's ability to creatively solve difficult, pertinent problems. TRIZ provides repeatability, predictability, and reliability due to its structure and algorithmic approach. "TRIZ" is the (Russian) acronym for the "Theory of Inventive Problem Solving." G.S. Altshuller and his colleagues in the former U.S.S.R. developed the basic method between 1946 and 1985, and it has been

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  • Validation of Off-the-Shelf Software

    19 April, 2017 David S. Brown, President of David S. Brown LLC, A Consulting Firm

    "Previously published on www.MedicalDeviceSummit.com, Copyright: Innovative Publishing Company, LLC. Reprinted with permission"

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  • Six New FDA Enforcement Policies: How They Impact You

    Dr. Marla A. Phillips, Director, Med-XU, Xavier University

    On August 6, 2009, FDA Commissioner Dr. Margaret Hamburg publicly announced the FDA's new enforcement strategy. This strategy involves six new policies that went into effect on September 15, 2009. What are the policies and what do they mean to you?

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  • Tools to Circumvent Pitfalls on the Path to Your IND/NDA Milestones

    MasterControl

    PharmaDirections presents a new webinar: Tools to Circumvent Pitfalls on the Path to your IND/NDA Milestones: Avoid risks, surprises and wasted resources with confident pre-clinical and CMC critical path planning.

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  • What to Expect When They're Inspecting - Part 1

    18 October, 2011 Holly Scott, Biologics Consulting Group, Senior Consultant and Former CBER Consumer Safety Officer and FDA Field Investigator

    The next time you attend an industry function like BIO, BioEast, or an AABB conference, start up a conversation about FDA inspections with those seated at your luncheon table. It's more than likely that everybody will describe a different inspection experience and that no two perceptions will be the same.

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  • What to Expect When They're Inspecting - Part II

    10 April, 2012 Holly Scott, Biologics Consulting Group, Senior Consultant and Former CBER Consumer Safety Officer and FDA Field Investigator

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • Writing and Enforcing Your SOPs for GxP Compliance Success - for Quality Professionals

    14 July, 2011 David R. Dills, Quality & Compliance Advisor

    This paper addresses the fundamentals of writing and enforcing your SOPs not only for compliance and in accordance with internal company policies and requirements but certainly for ensuring compliance with FDA requirements as well.

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  • Writing and Enforcing Your SOPs for GxP Compliance Success - for Life Science Professionals

    31 January, 2012 David R. Dills, Quality & Compliance Advisor

    Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.

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  • Clinical CAPA: CAPA Isn't Just for Manufacturing Anymore

    22 March, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    Note: The views expressed in this article are those of the author and do not necessarily represent those of her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • Drug Accountability in Clinical Trials

    3 May, 2012 Dr. Robbie Wong, Pharm.D., Clinical Development Consultant and Affiliate Assistant Professor, Dept. of BioEngineering, University of Washington

    It's not exciting, it's not cutting edge. It may be the last thing you think about when preparing for an FDA audit. You might scan the records and figure if all the lines are filled in, it must be okay. Or, the auditor might not look at it, so I will trust that the pharmacist did it correctly. After all, aren't pharmacists one of the most trusted professions? Consider this: if drug accountability is in question, then the whole study could be in jeopardy. Proving that the drug was administered to the patient that resulted in the effects seen from study drug is a key factor in determining the merit of a product candidate. The FDA has listed drug accountability as number three in a list of top five pitfalls.

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  • Highlights of the 2012 Revised EU Pharmacovigialnce Regulations

    29 January, 2013 Sidney N. Kahn, Pharmacovigilance & Risk Management, Inc.

    In December 2010, the European Commission (EC) published legislation for implementation in July 2012 that made the most sweeping changes to European pharmacovigilance since 1995. Directive 2001/83/EC, covering non-centrally approved products, was amended by 2010/84/EU, and Regulation EC/726/2004, governing centrally approved products and European Medicines Agency activities, was amended by 1235/2010. The goals of the new requirements are to:

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  • Introduction to High Risk Software Automated Testing

    24 April, 2013 Brett Castano, Clinical Operations Manager, RealityCorp

    In today's world, high risk software applications are managing a majority of clinical trial data collected in the field. In the early 2000s, the clinical trial industry saw a switch from managing the data collection process through manual means to doctors utilizing secure software applications that allow the doctor to enter the data electronically through the use of a computer or mobile device. MasterControl itself is an example of a high risk software system that is utilized within the clinica

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  • The Odd Couple - Quality vs. Research

    29 February, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    Compliance is often seen as a subjective word, and at best can mean something very different from one functional area to another within the same organization. The compliance requirements for a quality group are very different from those in R&D groups such as Clinical and Regulatory Affairs. Technology and processes can play a significant role in defining and meeting compliance requirements, however if the technology is not flexible and configurable it can become difficult to implement one solu

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  • Outsourcing Trends for 2012

    22 March, 2012 by Kate Hammeke

    With the goal of optimizing collaborations in the drug development industry, Nice Insight (http://niceinsight.com/) developed a quarterly survey to measure customer awareness and customer perception across 300+ contract research and manufacturers. Nice Insight's Q4 Pharmaceutical and Biotechnology Outsourcing Survey generated responses from 2,619 outsourcing-facing executives from big pharma (29%), specialty pharma (17%), emerging/niche/start-up pharma (22%), biotechnology (25%), and emerging biotechnology (7%). In addition to creating a research tool that aids sponsors in the outsourcing partner selection process and enabling CROs and CMOs to understand their position within the industry, Nice Insight also garners broad industry trends from its survey data.

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  • Implementing a Systems Approach to Parmaceutical Quality Systems

    22 April, 2012 Christine Park, Quality Architech, Christine Park & Associates

    In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn't changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations.

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  • EU Pharmacovigilance Legislation

    12 June, 2013 by Steve Jolley, SJ Pharma Consulting LLC

    The new legislation represents the biggest change to EU pharmacovigilance requirements since the formation of the European Medicines Agency (EMA) and will have a significant impact for regulators and industry.

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