• 10+ Years Delivering Industry News
  • 600+ Expert Contributors
  • 1,200+ Articles
  • 150,000+ Subscribers

Showing items tagged as Supplier

  • Strategic Design of the Supply Chain: Too Little, Too Late for Pharma?

    24 April, 2018 by Hedley Rees, Managing Consultant, PharmaFlow

    Prevent your supply chain from becoming neglected by strategically designing each link in the chain. The key to a successful supply chain isn't focusing on the endpoint but rather bolstering each location along the way.

    Full story
  • 4 Ways an EQMS Can Help You Improve Supplier Visibility

    9 January, 2018 by David Butcher, Staff Writer

    Leveraging a centralized electronic quality management system (EQMS) can help medical device manufacturers bring together all quality data, leading to greater visibility and solutions to at least four key quality challenges across the extended supply chain, according to MasterControl Senior Product Manager Terrance Holbrook.

    Full story
  • 5 Areas of Focus When Conducting Supplier Audits

    2 January, 2018 by David Butcher, Staff Writer, MasterControl

    Conducting supplier audits is a well-established way to identify, eliminate and prevent quality problems in a supplier’s products, processes or management system before the problems spread. Still, there are ways to improve supplier audits. In a recent article for Pharmaceutical Manufacturing, MasterControl Senior Product Manager Terrance Holbrook recommended five actions take to to better conduct onsite supplier audits.

    Full story
  • Supply Chain Risk Management: An Ever-Changing Mosaic

    19 September, 2017 Geary W. Sikich, Principal, Logical Management Systems Corp.

    We have recognized the need to better manage supply chain risks for the nearly two decades now. Yet, we still seem to be deluded into thinking that the modern supply chain is resilient to the point of invulnerability.

    Full story
  • Keeping Up With the Top Pharma Industry Trends of 2017

    18 May, 2017 James Jardine, Staff Writer, MasterControl

    A close look at the key trends that will have the biggest impact on the pharmaceutical industry this year.

    Full story
  • 5 Warning Signs of Diminishing Supplier Quality

    30 March, 2017 David Butcher, Staff Writer, MasterControl

    supplier’s quality system doing what it’s supposed to be doing? Would you know if it weren’t? How would you know if there were flaws in your supplier’s quality processes before the problems get worse? These are the questions MasterControl’s Terrance Holbrook attempts to answer for medical device manufacturers in a recently published post on MDDI’s Device Talk blog.

    Full story
  • The Migraine Known as the Supplier Audit — and Some Simple Remedies

    23 February, 2017 Ken Christie, COO, VTS Consultants

    The topic of supplier audits can cause severe anxiety and headaches for many biopharma companies. This pain stems from the combination of having to understand the applicable regulations, determine the elements of a supplier audit in terms of criticality, establish the frequency and type of audits to be performed based on this evaluation, and follow-up on any issues found. Sufficient time is needed to prepare for and execute such activities, and time is one thing few of us have enough of. However

    Full story
  • Supplier Qualification: An Important - and Often Neglected - Validation Component

    2 February, 2017 by Robin Nozick, Business Development Consultant, BC Solutions, LLC

    Full story
  • 12 Free Resources to Supercharge Your Supplier Management System

    31 January, 2017 James Jardine

    To get what they truly want, businesses—just like people—often must rely on outside help. Even the most adept companies with the best ideas need to rely on external collaborators at some point if they want to achieve their aspirations and accomplish big tasks. Partnering and outsourcing are compulsory, mutually beneficial practices in today’s dynamic business environment.

    Full story
  • Santa Claus Is REAL but He Requires an EQMS!

    20 December, 2016 Marci Crane

    Once upon a time your parent or some “responsible” adult decided to be a big dope and tell you that Santa Claus wasn’t real. You, always the awesome kid on the block, took the news with grace but nevertheless it carved a scar onto your tender little heart.

    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
  • 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
  • Changing Supplier Controls Requirements

    26 March, 2014 by John E. Lincoln, J.E. Lincoln and Associates

    Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.

    Full story
  • Grid Analysis for Simplified Supplier Selection

    12 November, 2013 Jennifer Stepniowski, Communications Director, Pro QC International

    The selection of a new supplier can be an arduous process, and the importance of the decision is inarguable.  Changing suppliers when continuous improvement recommendations fail to succeed most surely will result in high switching costs.  Ultimately, the decision is worth careful evaluation, which makes a grid analysis a useful and easy tool to use.

    Full story
  • Elements of Effective Quality Agreements

    14 August, 2013 Steven Sharf, President and Principal Consultant, GMP Concepts

    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
  • Developing a Supplier Scorecard

    23 May, 2010 Dr. George L. Harris, DBA, CPM, CPCM, President, Calyptus Group

    Organizations have attempted to measure supplier performance in a number of ways as a part of their quality management program, based on customer requests, or as part of the effort to manage supply chain risk. Supplier measurement systems have been in place since the mid 1970s with varying degrees of success, both in the product and service industries. Typically, suppliers are provided measures and targets as performance indicators, data is collected on performance and published, and the buyer w

    Full story
  • The 'Supply Chain' Patient is Sick

    21 February, 2012 Hedley Rees, Biotech PharmaFlow

    Hedley Rees looks at the problems with the pharmaceutical supply chain and questions whether they can be resolved.

    Full story
  • SPC vs SQC: The Strategic Difference

    1 May, 2013 Jason Orloff, Statistical & Engineering Consultant, Pharmstat

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

    Full story
  • Ways to Ensure Supplier Compliance

    15 May, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Your suppliers are critical to your success. They can increase your company's efficiency-in terms of time, cost, and quality. But in some cases, suppliers can put their clients in hot water; this is especially true if those clients are regulated companies.

    Full story
  • How to Build a Strong Supply Chain Team

    30 October, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    In today's fiercely competitive global market, finding good suppliers that help create efficiencies, reduce cost, and support compliance efforts is critical to the success of manufacturers in regulated environments. Let's say you have found excellent suppliers, the question is: How do you maintain control over your suppliers and also keep good relations with them?

    Full story
Subscribe