FDA White Papers & Case Studies

  1. Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids 10/17/2018

    Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.

  2. Enhancing Process Safety In The Pharmaceutical Industry 3/23/2018

    This paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system.

  3. Security Of Pharmaceuticals: A Comparison Of EU And US Standards 2/27/2017

    Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However, the US and Europe are also a lucrative target for drug crime.

  4. Improving Quality Processes For Medical Device Development And Manufacturing 3/21/2013

    Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. By Mike Kuehne, ACSYS, Inc.

  5. Selecting, Implementing, And Using FDA Compliance Software Solutions 2/28/2013

    We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”

  6. eTMF And The eClinical Universe 2/21/2013

    How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.

  7. Signature Requirements For The eTMF 2/19/2013

    Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.

  8. An Introduction To The Challenges Presented By Product Codification & Serialization In The Pharmaceutical Sector 10/25/2012

    It is well recognized that the counterfeiting of pharmaceutical drugs and medical devices is a real and constant threat to patient safety. It is a global issue that affects all of us. By Darren Atkinson

     

  9. California 2015 Serialization & e-Pedigree: Strategic Planning 5/30/2012

    Those that have heard me speak at industry events, private management workshops, or webinars know that I am always asking “What can we do better?” The “We” is you, the client, and PharmTech. By Michael Stewart

  10. Evolving From Cold Chain Logistics Management To Cold Chain Logistics Control 9/7/2011
    Particularly for companies involved in the life sciences, the entire field of cold chain logistics has undergone significant changes in a relatively few years.