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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 »
By Emil W. Ciurczak, DoraMaxx Consulting
Published November 13, 2014
Fixing quality problems that put patients and the supply chain at risk. Read More »
Published October 20, 2014
Launches new advanceONE Division 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 »
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 »
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 »
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 »
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 »
Published January 15, 2014
Above all else, quality at WellSpring is never compromised. Consistently exceeding the highest levels of quality has been a large factor in WellSpring's success. At WellSpring, we take pride in offering: Full Quality Services capabiliti… 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 »
The Wild West of Basic Discovery
By Nancy Gillett, Charles River Laboratories
Published November 13, 2013
R&D outsourcing issues Read More »
Published November 5, 2013
Published October 24, 2013
Invests more than $200 million at Rocky Mount, NC plant Read More »
Newsmakers: Frithjof Holtz on EXCiPACT
By Gil Y. Roth, Contract Pharma
Published October 9, 2013
In July, Merck Millipore completed an audit for EXCiPACT, a new voluntary standard for pharmaceutical excipient suppliers. We talked to Frithjof Holtz, head of MM-QS Advocacy, Merck Millipore Quality and Regulatory Management, about the pro… Read More »
By Jason S. Collins, IPS-Integrated Project Services
Published October 9, 2013
Aseptic processing designs must advance Read More »
By Heather D. Banuelos, Hunton & Williams LLP
Published October 9, 2013
Evaluating IRB responsibilities and determining IND exemptions Read More »
Picking Tomorrow’s Winners
By Peter Pollak and Andrew Badrot, CMS Pharma
Published October 9, 2013
Review the business development cycle in the custom manufacturing industry and assess risks associated with pharmaceutical fine chemicals manufacturing Read More »
FDA’s Quality Agreement Guidance Vs. EMA’s cGMP Regulations
By John Avellanet, Cerulean Associates LLC
Published October 9, 2013
Can you comply with both? Read More »
By Gil Roth
Published September 20, 2013
Will combine Life Sciences, Diagnostics and Genomics, spin off Electronic Measurement Read More »
By Gil Roth
Published September 19, 2013
Improve environmental impact, provide cost efficiencies for cold chain distribution Read More »
By Gil Roth
Published September 19, 2013
Solid dose med to be produced at Queenborough, UK site Read More »
By Gil Roth
Published September 18, 2013
Expects European inspection within year Read More »
By Gil Roth
Published September 18, 2013
Customer demand pushes 20% increase in capacity Read More »
By Gil Roth
Published September 17, 2013
Excipients certification initiative to make global splash Read More »
By Gil Roth
Published September 16, 2013
EMA reorganizes to cover drugs' lifecycles Read More »
By Gil Roth
Published September 16, 2013
Lee rejoins bio-CMO Read More »
By Gil Roth
Published September 12, 2013
Will help coordinate Crinone supply chain Read More »
By Gil Roth
Published August 28, 2013
Injectables to lead the way, Asia to emerge as solid dosage destination? Read More »


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