• Using Good Systems Practice to Right-Size IT Services for Emerging Biotech Firms

    19 April, 2017 Keith Parent and Christopher Port

    By Keith Parent and Christopher Port

    Full story
  • Harmonization of Quality Groups and Automated Quality Audit Systems

    19 April, 2017 Chris Ball, AMGIT

    The term harmonization has become a buzzword in the life science sector and doesn't just refer to the harmonization of international standards created by various regulatory (or voluntary) bodies but can also refer to the harmonization of company-wide cultural and political differences as well as the harmonization of varying policies and procedures introduced by company mergers and acquisitions.

    Full story
  • 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

    Full story
  • 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"

    Full story
  • Value Adds to ISO 9001:2000 Compliance

    19 April, 2017 Sandford Liebesman

    There are three major ways 8.5.1 can be improved. Who is responsible for compliance to this requirement? Top management should have the responsibility. Also, there is no requirement for a process to accomplish continual improvement. Finally, how does one measure the effectiveness of the quality management system? Without a defined measurement of effectiveness it will be difficult to show improvement.

    Full story
  • Pundits Forecast Pharma's Future

    18 April, 2017 MasterControl

    End of first-quarter economic reports are pouring in and the economic pundits are pondering the industry's performance in 2007 and forecasting the future of pharma in the remainder of 2008.

    Full story
  • Taming the Regulatory Beast: Role of Regulatory Trend Analysis in Successful FDA Approval

    18 April, 2017 Mukesh Kumar, PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research, Germantown, MD

    The biggest risk in drug development is failure to convince the FDA that your product meets the requirements for marketing approval. By the time a company files a New Drug Application (NDA), it believes that sufficient evidence is available in support of the marketing approval, based on its understanding of the regulations and requirements. However, about 40% of the NDAs submitted to the FDA are rejected for one or another reason while more than half go through multiple cycles of review adding a

    Full story
  • SPL R4: The Latest on Electronic Regulatory Submissions

    18 April, 2017 Keith Thomas, Product Strategist and Former Director of R&D, i4i

    As of June 1st, 2009 the FDA will no longer accept Establishment Registrations or Product Listings submitted on paper for human prescription drugs, human over-the-counter drugs, or listed biologics and veterinary medicines. After that date, all such filings must be made electronically through the FDA's electronic submission gateway and encoded in XML, according to the rules set out in the HL7 Structured Product Labeling (SPL) standard and the FDA implementation guide. Medical devices are not c

    Full story
  • Submissions Processes with Templates for Microsoft Word®

    18 April, 2017 Antoinette Azevedo

    As regulatory agencies such as the U.S. Food and Drug Administration (FDA), and parallel agencies in Europe, Japan, and Canada, move toward a completely electronic submission environment, tools like templates for Microsoft Word® become increasingly essential to submissions content development processes. Templates can be essential during the preparation of electronic common technical documents, or eCTDs. The eCTD is a standard created by the International Conference on Harmonisation (ICH), a

    Full story
  • Good Clinical Practices and the Top Five GCP Violations in a Clinical Study

    18 April, 2017 Michelle Sceppa, Principal at MSceppa Consulting

    Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, biologics, devices, therapy protocols). These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. The regulations that provide a platform for the quality of the data are Good Clinical Practices or GCPs.

    Full story
  • The 5 'W's of Quality Agreements

    18 April, 2017 Arvilla Trag, ASQ Certified Quality Auditor, Midwest Consulting Services, Inc.

    What is a Quality Agreement, and what should be included?

    Full story
  • Quality Audit - A Tool for Continuous Improvement and Compliance

    18 April, 2017 Jason Clegg, Marketing Director, MasterControl, Inc.

    The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.

    Full story
  • Please Don't Call Them CAPAs

    18 April, 2017 Denise Robitaille, RAB-QSA Certified Lead Assessor, Author and ASQ Certified

    I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separa

    Full story
  • Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review

    18 April, 2017 Kerry Potter, Founder and President of Summit Consulting, Inc.

    What happens when the FDA arrives at your manufacturing facility? Your first reaction may be panic or perhaps regret for not having solved any wayward problems the inspection team will surely now find. But it does not have to be that way. In fact, by preparing in advance and using the right tools, a firm should be able to greet the FDA by saying, "Excellent. Everyone knows what to do. Let's get right to it." That is the exact attitude companies need to have to successfully pass any inspection.

    Full story
  • 19 Key Elements to Review for Effective Audits

    18 April, 2017 Dr. George L. Harris, DBA, CPM, CPCM, President, Calyptus Group

    Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination o

    Full story
  • FDA Electronic Submissions, IT Changes Challenges

    18 April, 2017 MasterControl

    Where’s the hot spot at the Food and Drug Administration these days?  With product recalls, new hires at top levels and an impending election, there’s more than enough sizzling seats to go around at the Agency.  

    Full story
  • Investigating Clinical Trial Investigators Means More Headache for Drug Sponsors

    18 April, 2017 Michael McCaughan

    One leading indicator of a more enforcement-minded approach at the food & drug administration may be a crackdown on clinical trial investigators suspected of fraud. One thing is already clear: sponsors who rely on investigators who trigger suspicions will pay a price in the form of an even tougher time getting the drug through FDA.

    Full story
  • All New Electronic Submissions Must Conform to eCDT format - For Pharmaceutical Industry

    18 April, 2017 Lane Hirning

    For well over a decade, there has been an initiative by the International Conference on Harmonization (ICH) to standardize formats for new drug applications in the U.S., Europe, and Japan (where the majority of new medicines are developed).  In the past, the format and organization of submissions varied by country, which made it difficult and time-consuming for a U.S. drug company, e.g., to submit an application for drug approval in Japan or the United Kingdom, and vice versa. A com

    Full story
  • New FDA Guidance to Balance Risks and Benefits of Drugs

    18 April, 2017 MasterControl

    FDA to Provide Emerging Drug Safety Information

    Full story