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  • Ten Steps to Process Improvement, Part 2

    Following a proven framework can get an improvement program off the ground and ultimately, lead to success for managers at all levels.

    Ronald D. Snee, Ph.D., Principal, Tunnell Consulting, Inc.
  • Prioritizing Goals by Applying Options Thinking

    Applying systematic methods can improve results and increase value, whether on the corporate or on the local operational level.

    Brian W. Hagen, Ph.D., Raymond L. Manganelli, Ph.D., and Thomas L. McGurk, Practice Director, Tunnell Consulting
  • On-Line TOC: Will Marketing or Science Prevail?

    As new players enter the market and a standard is proposed to ASTM’s E-55 committee, a great deal of controversy is swirling around on-line TOC analysis for pharmaceutical-grade water. The world’s leading technical experts are aligned with one vendor or another, so it’s up to the user to filter through the marketing-speak and determine which technology will best meet specific installation needs.

  • Validating On-Line TOC Analyzers for Real-Time Release

    Robust analytical TOC method validation is essential to the success of any on-line TOC system, particularly systems that release pharmaceutical-grade water in real time. Meeting USP 643 or EP 2.2.44 specifications may not eliminate risk.

    Jon S. Kauffman, PhD., Lancaster Laboratories
  • How Early Communication with FDA Sped Up One RMM Implementation

    Rapid Microbial Methods (RMMs) offer another tool that can facilitate Lean Manufacturing in biologics and pharmaceutical manufacturing, and taking the industry a few steps closer to parametric product release. Proactive communication with FDA reviewers was instrumental in getting approval for one RMM implementation project at a major pharma company. Rich Boehler discusses how his team at a previous (unnamed) employer went about the implementation.

    Agnes Shanley, Editor in Chief
  • Managers: Outsource-Proof Your Job

    Think you're the only ones doing the outsourcing? Guess again. You'll need to be logical, of course, by moving away from the decision tree and injecting unique creativity - this is the key to preventing your position from moving offshore.

    John M. McKee, Four Windows - No Walls Consulting, LLC
  • Therapeutic Dose: The Importance of Design Qualification

    The DQ is a critical, yet often overlooked part of the process of developing and validating any new pharmaceutical PAT process. It is a strategically important time, where process engineers, material scientists and physical chemists can get together to develop meaningful materials characterization standards.

    Emil W. Ciurczak, Cadrai Technology Group
  • Proactive QC at Talecris: Leave Nothing to Chance

    With human-plasma-derived products, the potential for risk is high. Talecris Biotherapeutics’ QA process is designed to minimize risk all along the supply chain. SVP of Operations Mary Kuhn discusses how quality is maintained on the manufacturing plant floor.

    Agnes Shanley, Editor in Chief
  • Laser Drilling Tablets for Use in Osmotic and Other Novel Drug Delivery Systems

    An overview of laser drilling, a technique used in medical device manufacturing, shows that it might offer benefits for use in combined drug-devices. It allows precise drilling of tiny holes into tablet surfaces at high throughput levels.

    Frank Gaebler, Coherent, and Graham Coffee, Control Micro Systems
  • RFID's Near its Tipping Point...

    Implementing track and trace technology is not some science project, but an imperative for the drug industry, writes Laura Osbursen, director of enterprise security for Unisys. However, the factors that have held it back may soon be disappearing.

    Laura Osburnsen Director, Enterprise Security, Unisys Global Commercial Industries
  • Detailed Study Shows ROI and Savings from RFID Implementation

    A study just released by the University of Texas (Austin) shows that pharma companies that implement RFID typically realize 900% ROI. The technology should save the industry and the healthcare sector $46 billion, the research suggests.

  • How to Project Leadership Qualities (Even When You're Scared Stiff): Speak Out and Speak Strong

    Is your career advancing as quickly as you'd like? If not, take a good, honest look at the way that you communicate. Are you projecting "leadership" qualities? This article presents tips that will make you appear self-assured and confident, even if you aren't. Wallflowers, take heart. Play the part of the confident leader often enough, the author suggests, and you'll become a leader, whatever your sphere of influence.

    John M. McKee
  • Pharmaceutical Industry Management and Careers | How to Project Leadership Qualities (Even When You’re Scared Stiff): Dress and Act the Part

    Leadership is conveyed not only by the way you express your opinions, but by such things as the way you dress and present yourself (and even the way your office is set up). Career coach John McKee offers five keys to "looking and acting" like a leader. With practice, he says, they'll transform you into a more confident person (and the change is likely to be noticed by those who can advance your career).

    John McKee
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