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Defining Approaches and Best Practices for Quality Agreements
Published May 5, 2015
Scott Gunther of Catalent discusses critical issues with Quality Agreements, how best to address them, and key areas the FDA guidance will likely focus on.… Read More »
By Suzanne Tran, Technical Resources International
Published April 1, 2015
Collaboration is key in conducting successful clinical trials Read More »
Still Using Paper-Clips to Address Quality Culture?
By Gerry Creaner, CEO of GetReSkilled
Published April 1, 2015
How to include quality behavioral metrics in supplier agreements Read More »
Published March 10, 2015
Beck to drive quality strategy and policy across the Group Read More »
Published February 27, 2015
Shifts production in-house after US FDA concerns about CMO Emcure Read More »
Published February 13, 2015
The presence calcium-ketorolac crystals identified following customer report Read More »
Published February 3, 2015
Sullivan replaces Robert Jamnick, who is retiring Read More »
The Major Pitfalls of Quality Risk Management Practices
By Dr. Ben Locwin, Healthcare Science Advisors
Published January 29, 2015
Learning to avoid these will help set facilities up for success. Read More »
Heavy Metals in Drug Products
By Nikki Schopp, Team Leader in charge of ICP-MS, ICP-OES and AA testing, SGS
Published January 29, 2015
The potential presence of trace amounts of heavy metals in drug products is a real cause for concern with regulators. Read More »
2015 Resolve to Take a Closer Look at Risk-Based Monitoring
By James Streeter, Senior Director, Oracle Health Sciences
Published January 29, 2015
Reducing the cost of clinical trials likely tops the list of New Year resolutions for many health sciences organizations. Read More »
Published January 15, 2015
Above all else, quality at WellSpring is never compromised. Read More »
By Emil W. Ciurczak, DoraMaxx Consulting
Published November 13, 2014
Fixing quality problems that put patients and the supply chain at risk. Read More »
The New EU GMPs for Cross Contamination
By Stephanie Wilkins , PharmaConsult US, Inc.
Published November 13, 2014
Industry needs to prepare in order to comply with the updates. Read More »
Published October 20, 2014
Launches new advanceONE Division Read More »
Using Microscopical Analysis Methods
By Gretchen Shearer , Senior Research Chemist, McCrone Associates, Inc.
Published October 14, 2014
The integrity of the container system is crucial to the safety of parenteral products. Read More »
Assuring Quality from CMO’s
By Dr. Kevin Siver, PhD, Onyx Pharmaceuticals
Published October 1, 2014
Serving Patients is a Privilege. This Privilege Comes with Significant Responsibilities Read More »
Newsmakers: Lean Six Sigma and Seeing the Forest Behind the Trees
Published September 8, 2014
A new book on Lean Six Sigma aims to go beyond the tools, to uncover deeper potential within organizations Read More »
Viewing Risk From a High Level
By Robert Dodd, Aloft Aviation Consulting
Published September 8, 2014
Where FMEA, fault tree and other risk management methods drill down to the tiniest detail, Bow Tie methods allow for a broader view of risk throughout the enterprise. Read More »
Risk and Quality Management: Connecting the Dots
By Bikash Chatterjee , President and CTO, Pharmatech
Published September 8, 2014
A brief review of pharma’s new thinking regarding quality and risk management, and key risk management tools Read More »
Strengthening Pharma Ethics and Compliance
By Agnes Shanley , Editor
Published September 8, 2014
Research suggests that the most effective corporate programs support business strategy, and are closely linked to risk and quality management. Read More »
Published August 15, 2014
Vassilopoulo and Chaturvedi to head QA and QC Read More »
Published June 9, 2014
Anicetti brings 30+ years of quality and regulatory experience Read More »
Analyzing and Controlling Particles in Biopharmaceuticals
By Tara Sanderson , Formulation Services Manager, SGS
Published June 3, 2014
Patient safety depends on preventing particulate contamination in biopharmaceuticals. Read More »
Ensuring Drug Quality in a Global Economy
By Helena Champion , Principal Consultant, Drug Quality Assurance LLC
Published May 1, 2014
Offshore CMO’s have proven a weak link in pharma’s supply chain. Will recent quality problems in India and China increase oversight? Read More »
Published April 17, 2014
Brown brings 20 years of industry experience Read More »
Quality is a Business Driver, Not a Cost Center!
By Kristin Brooks
Published April 15, 2014
KR Karu, Industry Solutions Director for Sparta Systems, discusses the mindset required to align quality with profitability, based on his Interphex 2014 presentation. Read More »
Reducing the Risk of Delamination
By Bernhard Hladik , SCHOTT Pharmaceutical Systems
Published April 3, 2014
Why it happens and ways to solve the problem Read More »
Published April 1, 2014
Brandreth to head quality and compliance functions for clinical trials Read More »
Outsourcing & Lean Manufacturing: Product Quality & Waste Elimination
By Paul M. Reece & Leonard B. Antosiak , Paul M. Reece Consulting & Pharmaceutical Production TechSource
Published March 7, 2014
Lean philosophies can save your business time, energy and money. Read More »
By Kristin Brooks
Published February 20, 2014
Allows companies to outsource biologic QC testing Read More »
By Kristin Brooks
Published February 12, 2014
Kile brings 27 years of industry experience Read More »
By Kristin Brooks
Published February 6, 2014
Blume, Hunter, Anglin, Miller Achieve KYCPE, ASQ Certifications Read More »
By Gil Roth
Published February 5, 2014
First-year goals met Read More »
By Kristin Brooks
Published January 27, 2014
Yuen brings 30 years of compliance experience Read More »
Risk Assessment for Single Use Disposable Projects
By Chuck Stock, IPS
Published January 22, 2014
Building quality and value into manufacturing processes Read More »
Published January 13, 2014
QbD is a systematic approach to pharmaceutical drug manufacturing development. QbD is built on a deeper understanding of the causes and effects of variability in the manufacturing process. This understanding is based on sound science and risk managem… Read More »
Published January 13, 2014
Is your development or manufacturing operation experiencing cost over-runs and unproductive delays? Do you want to optimize your development dollars and ensure a robust commercial process? You are not alone. The conventional development process uses… Read More »
By Gil Roth
Published January 8, 2014
No observations at Manchester, NH site following GMP/PAI visit Read More »
By Kristin Brooks
Published December 20, 2013
To use MODA-EM for environmental and utility monitoring programs Read More »
By Gil Roth
Published December 19, 2013
Potential $4.3 billion deal plus royalties through 2025 Read More »
By Gil Roth
Published December 18, 2013
CMO issues apparently resolved Read More »
By Gil Roth
Published December 10, 2013
Spokane CMO facility cited by agency Read More »
By Gil Roth
Published November 18, 2013
Combines microbio validation and screening with rapid detection platform Read More »
Dequantify Yourself
By Rick Piazza, Medidata
Published November 13, 2013
Are all those system metrics your friend or foe? Read More »

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