Showing items tagged as Pharma

  • Communicating Priorities to Your Employees

    16 September, 2014 Curt Porritt, SVP, Marketing, MasterControl Inc.

    Needless to say, if managers don’t understand corporate priorities, they can’t communicate them to employees. Entire departments may pursue the wrong priorities, causing stra­tegic corporate plans to become less effective. I’ve seen a lot of this. Likewise, if managers understand the priorities, but have not communicated them well to their departments, the results can be the same. And if employees are left to themselves to decide what the priorities are, not only are the efforts of your teams unlikely to match corporate goals, they probably won’t even match each other. You will likely have employees working in different directions, even within the same departments or even on the same projects.

    Full story
  • Choosing the Right Drug Name: How to Increase Your Chances for Approval

    4 September, 2014 Susan M. Proulx, President, Med-ERRS

    The pharmaceutical industry is all too familiar with how exceedingly challenging it can be to achieve a viable trademark that is accepted by the health authorities, especially if obtaining a global mark is the end goal. Over the past few years, health authorities in several countries have been developing their proprietary name guidances. In the last six months alone, both Health Canada and the FDA released guidances pertaining to proprietary name development – Health Canada’s proprietary name guidance was finalized and FDA released its first-ever initial draft guidance on the topic of name selection and development. Industry is now curious to learn how these guidances will affect their current trademark development and selection process and their trademark’s chance of approval.

    Full story
  • FDA Issues New Q&A On Data Integrity

    2 September, 2014 Jamie Colgin, Colgin Consulting, Inc.

    Recently FDA published a new set of seven questions and answers. Three questions cover data integrity and e-signatures. While the Q&A target GMP, there are lessons to be learned for all of us:

    Full story
  • What You Don't Know About the Drug Supply Chain Security Act (DSCSA) Implementation Plan

    28 August, 2014 Peter Knauer, Senior QCC Consultant, MasterControl Inc. and Moj Eram, Regulatory Consultant

    This article discusses the implementation aspects of the new Drug Supply Chain Security Act (DSCSA), which was signed into law (Title II of Public Law 113-54) by President Obama on November, 27, 2013. The Act intends to build a comprehensive, standard electronic and interoperable system to identify and trace prescription drugs in the US.

    Full story
  • Regulatory Records Primer Part 2: Decoding the Requirements for Pharmaceutical Manufacturers

    26 August, 2014 Les Schnoll, Quality Docs, LLC

    In Part 1 of the Regulatory Records Primer (Decoding the Requirements for Medical Device Manufacturers), I discussed the general requirements and thought processes undertaken by the FDA with respect to regulatory records.  While the drug side has not yet “evolved” to using a quality systems approach to the regulatory requirements, the same basic process holds true.  Following is a discussion on the regulatory records required to be maintained by manufacturers of finished drug products.

    Full story
  • Questions All Auditors Should Ask: The Use and Misuse of Audit Checklists

    31 July, 2014 by Laurie Meehan, Polaris Compliance Consultants, Inc.

    There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: “Why?” So how can you develop the best checklists possible and avoid relying on them too heavily?

    Full story
  • Are You Ensuring Supplier Quality?

    8 July, 2014 Christine Park, Quality Architech, Christine Park & Associates

    "Everyone cares about quality. Just ask them. However, unless someone actively measures quality performance, you must question the commitment to improvement."

    Full story
  • Partnering with Quality Professionals Worldwide

    19 June, 2014 by Jon Beckstrand, CEO, MasterControl Inc.

    MasterControl has grown our reach significantly over the last 10 years—from a small provider of a narrowly focused document control product to one of the largest organizations in the world focused on helping quality and compliance professionals achieve their purpose. I have met with many of the world’s top quality professionals over the past 10 years and I have been amazed by their devotion and commitment. I have recently found myself asking the question: What drives these dedicated people? Why are they so passionate about their jobs? I believe I have found the answer and it has had a strong effect on how I view MasterControl’s mission.

    Full story
  • Quality’s Role in Drug Approvals

    12 June, 2014 by Theresa Allio, Ph.D.

    In a recent review, I summarized the underlying reasons contributing to delayed market entry for 51 product applications submitted to CDER between 2009 and 2012.1 Reasons cited in the complete response letters issued for these applications covered a number of areas, including safety, efficacy, regulatory, labeling and quality related issues. Quality- related issues were one of the most prominent reasons for delay of market entry with deficiencies being cited in 20/51 (39%) of applications. GMP inspection failures and data deficiencies contributed equally to the quality citations. The prominence of quality-related issues in the delay of product approvals emphasizes the importance of robust quality programs in drug development. Understanding what elements have posed as hurdles in past development programs will help a sponsor avoid these pitfalls in the future.

    Full story
  • 7 Steps to CAPA Success

    10 June, 2014 by David R. Butcher, Marketing Communications, MasterControl

    A formal Corrective Action/Preventive Action (CAPA) can be a powerful tool for meeting current regulatory requirements. Done right, the systematic investigation of the root causes of identified problems or identified risks will prevent their occurrence or recurrence. For many companies, however, a crucial obstacle to CAPA success persists: adequate documentation of actions taken to achieve quality success.

    Full story
  • How Can You Measure the Return on Your QMS Investment?

    29 May, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.

    Full story
  • How to Cut Your Document-Approval Cycle Time Using Escalation

    27 May, 2014 by Marty Jackson, Professional Services Consultant, MasterControl Inc.

    From SOPs and procedures to CAPAs and deviations, most regulated companies maintain document-based and form-based processes for compliance and business reasons. How do you get approval for your documents and forms? How many processes do you have and how long is your approval cycle time for each one?

    Full story
  • Ruined by Best Efforts

    22 May, 2014 by Craig Gygi, Executive Vice President, MasterControl Inc.

    When W. Edwards Deming famously said, “We are being ruined by ‘best efforts,’” he was conveying the idea that simply striving to improve—even with laudable effort—can actually have the opposite outcome. How can this be? How could good intentions and diligent work ever possibly sabotage us? Well, they do all the time.

    Full story
  • Conducting an Effective Failure Investigation: Going Deep Enough to Hit Root Cause

    24 April, 2014 by Christine Park, Quality Architech, Christine Park & Associates

    The FDA has increased focus on the effectiveness of failure investigations during recent inspections. A review of recent 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to really identify root cause.

    Full story
  • Leverage TOQ for a Faster, Cost-Effective Software Validation

    10 April, 2014 by Richard Dirkson, Senior Validation Services Consultant, MasterControl Inc.

    More and more regulated companies are using electronic quality management systems, but the concept of software validation remains a mystery to many engineers and quality professionals. In this article, I will try to shed light on the underlying goal of software validation within the context of FDA guidelines and offer a practical strategy.

    Full story
  • On the Quality of Vendor/Supplier Audit Responses

    8 April, 2014 by John Janeri, Independent CSV/Part 11 Auditor working with Polaris Compliance Consultants; Edited by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.

    Full story
  • More Helpful Quality Event Management Tips from MasterControl CAPA Presentation

    5 March, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    A previous post to this blog covered some of the highlights of a recorded MasterControl webinar that discusses best practices for corrective and preventive action (CAPA) systems. The free recording is presented by quality expert Ken Peterson, a prominent consultant who has decades of experience with risk management, customer service, and CAPA systems. Peterson has devoted his quality expertise to a long list of successful companies such as Pfizer, Abbott Laboratories, Kodak, and IBM.

    Full story
  • Medical Device Clinical Trials – How Do They Compare with Drug Trials?

    18 February, 2014 Brandy Chittester, Director of Clinical Monitoring Services, IMARC Research, Inc.

    It seems like the clinical research world is often thought of in terms of pharmaceuticals. Clinical trials are often referred to in Phases, such as “a Phase 2 study of a new drug” or “a Phase 3 randomized clinical study with a placebo control.” Although clinical trials for medical devices have many similarities to those for pharmaceuticals, there are some necessary differences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even be required!

    Full story
  • Responding to FDA 483s: Do’s, Don’ts, and When to Call In a Remediation Partner

    14 February, 2014 Lisa Weeks, Marketing Communications, MasterControl Inc.

    Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

    Full story
  • “3 Loops in 1” as Reflected in FDA Warning Letters

    12 February, 2014 Cindy Fazzi, Marketing Communications, MasterControl Inc.

    Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).

    Full story