Showing items tagged as Pharma

  • It's Not Just You: FDA Regulatory Requirements Really Are Increasing

    20 November, 2014 Alexander Gaffney, RAC

    The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year.

    Full story
  • Two Keys to Prosperous B2B Customer Partnerships

    4 December, 2014 James Jardine, Marketing Communications

    It may be a trite and simplistic aphorism, but it’s one that’s hard to live by in a competitive business world. Yet the companies that stay true to it are always the most successful. That’s because a company that provides products and services to other businesses is only as valuable as the value it supplies. Think of it this way: ‘why’ a company does what it does is even more important than ‘how’ the company does it or ‘what’ it is actually doing.

    Full story
  • Basics: Documenting a Real QMS

    18 December, 2014 T. Dan Nelson, Consultant

    Using ISO  parlance, a management system is designed to achieve objectives.   In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers.  A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.

    Full story
  • Stedman Graham Steps Out of Oprah’s Shadow, Shares Secret to His Success

    30 December, 2014 Cindy Fazzi, Editor, MasterControl Insider

    Stedman Graham, CEO of S. Graham and Associates and a best-selling author of motivational books, shared the secret to his success. No, it’s not Oprah, though he’s widely known for his long-time relationship with one of the world’s most famous media personalities. 

    Full story
  • Risk Management: A Primer for Lean Quality Assurance

    6 January, 2015 Gina Guido-Redden Co-Founder, Coda Corp USA

    In this article, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s quality professionals: risk management.

    Full story
  • What Does Risk-Based Monitoring Mean for QA Auditing?

    13 January, 2015 Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants, Inc.

    By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed. So what does that mean for quality assurance (QA) teams who audit these new processes? Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

    Full story
  • Setting an Organization's Risk Management Context

    15 January, 2015 Rod Farrar, Director, Paladin Risk Management Services

    There is considerable confusion in the risk world in relation to terms such as risk appetite, risk tolerance, risk acceptance, risk threshold and risk attitude (just to name a few).  These are defined differently by organisations and there is no guidance in ISO 31000 that clarifies this, so the confusion becomes a distraction.

    Full story
  • Risk Management in Clinical Research: Process and Application

    29 January, 2015 Emily Haglund, Clinical Auditor, IMARC Research Inc.

    Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding risk based approaches to clinical research. These documents include FDA’s “

    Full story
  • CAPA Should Not Be a Dreaded Four-Letter Word

    5 February, 2015 Cindy Fazzi, Editor, MasterControl Insider

    In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.

    Full story
  • Success By the Numbers (or Why Being Science-y is a Good Thing)

    12 February, 2015 Craig Gygi, Executive Vice President, Operations MasterControl

    How do you know if you know? In other words, how do you know when you have sufficient knowledge to reliably manage or improve a process? This last question reveals the foundation of all quality, regulatory, and compliance work.

    Full story
  • The Journey to Supply Chain Excellence

    12 March, 2015 Ed Rausch, VP of Global Marketing, Elemica

    Some goals haven’t changed. Businesses in 2015 still have the common pursuit of growing revenues, profits, and market space, and leading companies are relying on building collaborative relationships in their extended supply chains to meet these goals in a responsible and sustainable way. Building powerful and more intimate relationships, extending across a critical mass of trading partners, leads to continuous improvements in company performance, agility, and differentiation.

    Full story
  • Did the Titanic Follow ISO 31000 Risk Management Guidelines?

    19 March, 2015 David Patrishkoff, President, E3

    ISO 31000 (Risk Management) and its supporting publications encompass an impressive and useful "to-do" list of risk management guidelines to create and protect the value of an organization. However, if an organization selectively pursues some of the ISO guidelines and ignore others, highly undesirable events and tragedies can occur.  This is what happened with the Titanic.

    Full story
  • Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences

    2 April, 2015 Patricia Santos-Serrao,MasterControl's Market Segment Manager, Global Pharmaceutical, Blood & Biologics

    When describing the role of Regulatory Operations I have found that one of the best analogies of their role and responsibilities is to be the “air traffic control tower for interactions between a life sciences organization and a regulatory authority.” By no means is that their only role but it is an essential role that involves constant communication with various parties both internally as well as externally. Regulatory Operations personnel coordinate resources and documentation essential for filing of global applications such as INDs, NDAs, BLAs and MAAs for pharma/biotech organizations and of 510k and PMAs for medical device organizations.

    Full story
  • The Bright Future of Quality and Compliance

    14 May, 2015 Craig Gygi, Executive Vice President, Operations, MasterControl Inc.

    Quality and compliance stand at a crossroads. It’s the same crossroads that many other professional fields have navigated. Remember when computers entered the mainstream of business?

    Full story
  • Cosmeceuticals: the Good, the Bad and the Ugly

    19 May, 2015 MasterControl

    Since retiring from FDA, I have assisted numerous businesses in developing labels for “Cosmeceuticals.” I have also presented a number of training programs on the manufacturing and marketing of such products. When I was asked to write something using this specific title, I thought I would be able to quickly put an article together. At first, I had a difficult time putting pen to paper because I couldn’t think of anything “ugly” about cosmeceuticals as I define them. To get started I searched the Internet to see what others were saying about these products.

    Full story
  • How to Tip Off a GCP Auditor in 25 Words or Less

    21 May, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    When our GCP auditors conduct training and deliver guest lectures, they frequently hear those questions from class attendees. Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice. And other times, not so much.

    Full story
  • Change in Pharmaceutical Manufacture

    28 May, 2015 Peter Murray, Consultant

    Within the pharmaceutical industry, the concepts of validation, change, change control, deviation and out of specification (OOS) are often treated as distinct activities which operate with a significant degree of independence.

    Full story
  • Don’t Call Me Jim Cramer but Here are My Top 5 Pharma Trends

    3 June, 2015 Lane Hirning, Product Management Director, MasterControl Inc.

    Judging by a recent report forecasting future growth, the pharmaceutical industry is thriving despite the recent economic downturn. A market research firm is estimating a 30 percent increase in global medicine spending by 2018, which is great news for the industry (1). The same report cited the anticipated launch of 200 new revenue-boosting drugs within the next five years.

    Full story
  • 7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

    18 May, 2018 Ginette Colazzo, President, Ginette M. Collazo Human Reliability Consultancy

    As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of failures and defects. Sadly, little is known about the nature of these events mainly because the quest for answers ends where human error investigations should begin. This situation has become very evident to regulators and GMP enforcement agencies are being more critical of the approach, result, and effectiveness of corrective and preventive actions or CAPAs when dealing with human performance issues. In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations.

    Full story
  • Ensuring Proper Training for Clinical Research Staff in Less Time

    9 July, 2015 Sandra Maddock, President & CEO, IMARC Research

    There has never been a more exciting time to be involved in clinical research. We’re seeing more advances in life-changing medical devices and pharmaceuticals than at any other time in history, creating a growing demand for qualified clinical research associates.

    Full story