• 11+ Years Delivering Industry News
  • 600+ Expert Contributors
  • 1,200+ Articles
  • 130,000+ Subscribers

Showing items tagged as Pharma

  • February Tip: Continuous Employee Training Reduces Deviations and Nonconformances

    9 February, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

    This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .

    Full story
  • What Do Changes to Australia’s PIC/S Guide to GMP Mean for Pharma Down Under?

    1 February, 2018 by Luana Carone, Solutions Consultant for Australia/New Zealand, MasterControl

    It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.

    Full story
  • January Tip: How to Choose and Use External Consultants

    23 January, 2018 by Jake Walton, Quality Manager

    External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.

    Full story
  • 5 Most Common Pharma Form 483 Quagmires & How to Avoid Them

    26 December, 2017 by James Jardine, MasterControl Communications

    See the most common reasons the FDA cited pharmaceutical companies with Form 483 Inspectional Observations last year and examine potential remedies that can help prevent future warnings.

    Full story
  • What is Pharmaceutical Quality by Design?

    9 November, 2017 by Beth Pedersen, Staff Writer

    It seems that Quality by Test is well on its way to being a thing of the past, and for good reason. With only one out of every 10 drug products actually making it to market, it is no surprise that pharma companies are increasingly eager to adopt measures to ensure quality and manage risk. Quality by Design (QbD) continues to be a hot topic across the life science industries, and as evidenced by the widespread adoption of QbD among manufacturers, there is no question about its benefits.

    Full story
  • Don’t Let These Product Registration Problems Delay Your Time to Market

    7 November, 2017 by Cindy Fazzi, Staff Writer

    The combination of a lengthy process and high cost of drug development is a hard pill to swallow for pharmaceutical companies. It should serve as the biggest motivation for them to find fundamental ways to accelerate their overall time to market.

    Full story
  • Revisiting CAPA for a More Modern (and Effective) Approach

    17 October, 2017 by Peter Knauer

    Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?

    Full story
  • Gottlieb Says FDA Wants to Widen Access to Better Compounded Drugs

    13 October, 2017 by Karla L. Palmer

    We have witnessed this past week some noteworthy activity in the drug compounding space. Where will this lead traditional compounders and outsourcing facilities? What will it mean for compounders in the months ahead? We will just have to wait until FDA releases anticipated draft guidance on changes in outsourcing facility compounding in the coming months. FDA’s announcement about draft outsourcing guidance is somewhat of a headscratcher, especially considering that a number of anticipated compounding guidance documents and regulations were recently moved to CDER’s regulatory agenda inactive list (here; search "drug").

    Full story
  • Three Ways to Accelerate Your Lean Journey

    4 October, 2017 by Dan Markovitz, Markovitz Consulting

    I spent two days in St. Louis last week at the Global Lean Leadership Conference. It’s a small conference—only about 150 people—consisting of companies that have embraced Paul Akers’s 2 Second Lean philosophy. Companies that wanted to join the conference were required to have the president attend (although there were many other people from those companies as well).

    Full story
  • Anticipating Tensions Between Clinical Care and Study Protocol

    3 October, 2017 Laurie Meehan, Social Media Manager; Polaris Compliance Consultants, Inc.

    Protocol trumps practice. This principle seems clear enough, but complying with it is not always as straight-forward as it sounds. Years of practicing medicine has reinforced the way a physician responds to medical situations. But do these responses run counter to the investigational plan? Can a site’s commitment to standard of care affect its ability to meet enrollment targets? There’s a lot to consider.

    Full story
  • ISO, Regulatory Requirement Changes Loom

    1 September, 2017 by B. Christine Park; CQA, CQM/OE; Consultant

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

    Full story
  • EU Policy 70 and Redaction — PleaseReview’s Take on It

    1 September, 2017 by David Cornwell, Founder/CEO PleaseTech Ltd.

    This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.

    Full story
  • Good Communication Skills are Key for Inspection Readiness

    25 August, 2017 by UL

    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
  • Thoughts from 2017 PDA Quality Metrics and Quality Culture Conference

    24 August, 2017 MasterControl

    I had the pleasure spending two days networking and discussing quality metrics and quality culture with industry and FDA leadership at PDA's 2017 Quality Metrics and Quality Culture Conference last February. This year's conference included some of the most candid and honest dialog on these topics that I've seen between industry and FDA to data. I thought I would share some of the messages and my takeaways from the two-day event.

    Full story
  • Avoiding CAPA Pitfalls: 10 Tips from a Food Industry Quality Expert

    22 August, 2017 MasterControl

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

    Full story
  • 6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017

    8 August, 2017 Beth Pedersen

    Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment. As more device and pharma companies join forces to develop combo products, the traditional industry and regulatory boundary lines between the two sectors become blurred, presenting medical product makers

    Full story
  • Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials

    25 July, 2017 MasterControl

    When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.

    Full story
  • How Training Personnel on Your Quality System Can Produce Positive ROI. Don’t Stop at the Quality Manager.

    18 July, 2017 Greg Peckford, Founder, Quality Career Advancement

    Is the quality manager the only individual within an organization that requires training on quality and improvement methods? Absolutely not! In order for an organization to get the most value out of their quality program, and to ensure it is effective, is to train as many people as possible or even all employees, depending on the size of the company, on the concepts and strategies that its quality management system is based on.

    Full story
  • Developing a Quality System on a Managed Budget

    11 July, 2017 MasterControl

    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
  • Why the Supply Chain is So Important Toward Supporting Business Success

    6 July, 2017 MasterControl

    I term myself as an observer of multi-industry supply chains from respective management practitioner, technology implementer and industry analyst roles. I founded the

    Full story
Subscribe