May 29, 2018
The course is designed to help companies using or planning to use contract manufacturing organizations (CMOs) optimize the effectiveness of their outsourcing, by creating effective CMO/Client relationships, anticipating unique manufacturing needs, developing workable quality agreements, and risk based addressing of manufacturing and quality challenges.
April 5, 2018
Chris Smalley, an experienced sterile compounding pharmacist, works with pharmacists to design, build and operate compliant compounding facilities. His service to PDA includes 16 years on the PDA Science Advisory Board, two terms on the Board of Directors, and 12 years leading the Facilities & Engineering Interest Group.
March 12, 2018
Quality Risk Management and Microbiology Consultant Amanda Bishop McFarland has been published by American Pharmaceutical Review (“APR”). APR is the leading review journal for business and technology in the pharmaceutical industry throughout North America. McFarland’s cover feature, “Risk-Based Microbial Assessment Tool (R-MAT): A Novel Approach to Assessing Environmental and Critical Utilities Excursions” describes how the R-MAT can both assist in determining the appropriate actions for addressing excursions and help organizations develop a proactive means of preventing excursions.
“Despite the opportunity to employ risk management, some firms are still struggling with using risk-based methods when it comes to environmental monitoring and critical utilities excursions,” McFarland says….
January 22, 2018
Senior Consultant Kelly Waldron has earned a PhD in Pharmaceutical Regulatory Science, with a specialization in Quality Risk Management (“QRM”), from the Dublin Institute of Technology, Ireland. Research for Waldron’s thesis, “Managing Risk to the Patient: Recoding Quality Risk Management for the Pharmaceutical and Biopharmaceutical Industries” spanned three years and included insight from multiple industry regulators, QRM practitioners, and the Parenteral Drug Association (“PDA”).
Kelly’s research focused on defining how a QRM program should be designed and deployed to deliver value in an effective and efficient way….
December 28, 2017
ValSource, LLC today announced Whitney Kutney now heads ValSource operations as Vice President. ValSource, together with Engineering Software Solutions, LLC and ConcordiaValsource, LLC make up the ValSource family of companies.
“This move is a reflection of the overall strength of our managers and employees,” noted ValSource management. “It allows the company to continue focusing on strategic growth opportunities, further positioning ValSource to support its clientele with existing, new and enhanced services.”
Whitney Kutney has been with ValSource since March 2003….
November 14, 2017
Senior Consultant Igor Gorsky has been published by Contract Pharma. Gorsky’s article, “Sterile Manufacturing Future Trends and Challenges” addresses the biotechnology market’s unprecedented growth and the need for contract manufacturers to update their facilities with new technologies that increase efficiency and compliance.
“Sterile product manufacturing facilities are aging,” Gorsky commented. “While some firms are keeping their facilities current so that new generations of products can be manufactured with fewer risks and interventions, many are not.” He continued, “While reviewing recently issued FDA Forms 483 and Warning Letters, we are finding many firms are not up to par and compliant with elementary aseptic practices….
November 9, 2017
Mike Long, Senior Director of Consulting Services, is a recent contributor to BioProcess Online. Long’s article, “A Line-Of-Sight Approach To Continued Process Verification Planning” addresses the importance of planning for continued process verification (CPV) at the onset of product development. This occurs only when one understands important product and process attributes that must be monitored during the product’s life span.
“Any discussion of CPV planning must begin at Stage 1, process design,” Long commented. “It does not matter if the planning is for a new product, a tech transfer, or a legacy product….
October 26, 2017
Chief Operating Officer Hal Baseman is recently published by Pharmaceutical Online. Baseman’s article, “Five Keys to Aseptic Processing Improvement & Efficiency” explores, in the context of recent compliance trends, five guiding and linked principles for aseptic process improvement and efficiency in sterile health care products.
“Our objective should always be to modernize and improve aseptic processes,” Baseman commented. “Manufacturers of sterile products must engage in critical thinking, asking ‘Why?’ and ‘Why not?’ questions, challenging and pushing the industry towards more effective means of quality and process control….
October 16, 2017
ValSource today announced the ValSource Rapid Response Team. The team is a fast action, fast response group for clients needing to promptly address regulatory and compliance citation matters. The team was developed and strategically staffed to quickly mobilize and respond within the short time frames required for regulatory matters.
The team is comprised of ValSource’s senior knowledge group that includes specialists in microbiology, contamination prevention, process control, validation, data integrity, training, quality risk management, regulatory expectations and overall quality system implementation….
September 28, 2017
Chief Operating Officer Hal Baseman and Director of Learning Solutions James Vesper are featured presenters at the 2017 Parenteral Drug Association Annex 1 Workshop. The workshop, being held October 2-3 at the Omni Shoreham Hotel in Washington, D.C., is designed to present the newly released draft revision to EU Annex 1, Manufacture of Sterile Medicinal Products of the European Union Guidelines to Good Manufacturing Practice of Medicinal Products for Human and Veterinary Use.
“Make no mistake….