background image for GxP Lifeline
GxP Lifeline
  • 2017-bl-author-wolfgang-schmitt

    How to Become a QP in Europe

    Both the European Compliance Academy (ECA) and the European Qualified Person association (EQPA) are often contacted by people who would like to become a Qualified Person (QP according the EU Directives) outside of the EU. Is this possible?

    Full story
  • digital-business-documents-132

    Good Communication Skills are Key for Inspection Readiness

    When an FDA inspector comes to your door, it is usually a time of stress and uncertainty. You need to handle logistical elements like where the inspectors are going to be placed, how you.

    Full story
  • CAPA in the Food Industry: 10 Tips to Avoid Pitfalls from an Industry Quality Expert

    At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider

    Full story
  • Developing a Quality System on a Managed Budget

    Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction. Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving. Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy.

    Full story
  • smart-document-contract-132

    The Quality Metrics Journey

    One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.

    Full story
  • Training Does Not Stand Alone: The Quest for Training Effectiveness Continues

    While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?

    Full story
  • Why It’s Time to Revisit FDA’s Quality by Design

    Patients of Alzheimer’s disease, their families, and health care advocates recently encountered back-to-back disappointments when two clinical trials for Alzheimer’s drugs failed in quick succession. First, Eli Lilly & Co. stopped its late-stage clinical trial for solanezumab, then Merck & Co. ended its clinical trial for verubecestat. Both studies failed to show efficacy.

    Full story
  • The 15 Strangest Phobias and Why They Include the Fear of Paper

    It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.

    Full story
  • How to Practice Quality Management in Your Personal Life

    “Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone. 

    Full story
  • Supplier Approval Challenges Under FSMA

    As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog

    Full story
  • The Dude Abides! 5 Quotes from “The Big Lebowski” that Apply to Quality

    “The Big Lebowski” never fails to make me laugh. The 1998 cult classic, starring the indefatigable Jeff Bridges, features some of the most quotable lines in film. Saying them is enough to break the ice among strangers at a party. In my family, the quotes are inside jokes that never grow old.

    Full story
  • How to Respond to FDA Inspection Observations, Including Those You Dispute

    Although FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.

    Full story
  • Big Changes for ICH GCP & EU Regulations

    The most substantial change to international guidelines in 20 years occurred earlier this year when the ICH* issued a draft addendum to its GCP guidelines, ICH E6(R2).

    Full story
  • Data Integrity Starts With User Access

    In my next few blog posts, we'll be covering user access and how it can impact data integrity. For starters, let's explore the Principle of Least Privilege. What is it?  What happens when it's violated? Finally we'll map out five actions you can take to protect your company.

    Full story
  • Medical Device Development: Thinking Globally, Acting Locally

    The global healthcare and healthcare service market will maintain steady growth due in large part to an aging population that is living longer and to improved healthcare services in emerging markets that include China, Brazil, India, Japan, Israel, and South Korea, among others. It is interesting to note that countertrends seem to be developing in the medical device space; for example, hospital utilization of medical devices has slowed significantly, reimbursements continue to tighten, and there was a first-time global decrease (5%) in US premarket approvals (PMAs) in 2012, a trend that continued into 2013. There were also fluctuations in investor healthcare spending across 2012, drops in mergers & acquisitions deal value and deal counts, and a device tax that is adding to the squeeze.

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

    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
  • mc-logo-220x25

    Elements of Effective Quality Agreements

    Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.

    Full story
  • mc-logo-220x25

    New Draft Guidance on Quality Agreements: No Passing the Buck on CGMPs

    Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with

    Full story
  • mc-logo-220x25

    Quality Misconceptions

    For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality-related issue and are looking to quickly extinguish the fire and prevent recurrences. Or they may simply want to reduce their overall risks—and costs—by incorporating a specific quality initiative.

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]