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….
September 22, 2017
Compounding Pharmacy Consultant Christopher (Chris) J. Smalley has been appointed to the American Pharmacists Association (APhA) House of Delegates (HOD) as a delegate for the Academy of Pharmaceutical Research and Science. “This role presents authentic opportunities to inform the Association’s policy development process around compounding pharmacy,” Smalley commented. “Through networking and policy-related activities leading up to the House of Delegates meeting, I hear firsthand the new and exciting developments our clients and industry face. I’m able to advocate solutions borne of ValSource’s tailored, risk-based approaches to hospital pharmacies and compounding centers.”
The HOD is the principal policy-making body of the APhA….
August 30, 2017
ValSource Chief Operating Officer Hal Baseman, along with ValSource Consultants David Hussong, Mike Long and James Vesper, are contributors to the book, Aseptic and Sterile Processing: Control, Compliance and Future Trends. Through practical, sound science, the book reassesses current risks and technologies and considers new developments in the field.
“We’ve seen a rise in regulatory concerns about adequately determining the risk factors that challenge aseptic and sterile products processing,” Hal Baseman commented. “This book calls for a paradigm shift to the industry’s understanding of sterility….
August 15, 2017
Senior Consultant Marsha Steed is a featured speaker at the ECHO Consulting Group Educational Summit. The summit takes place Friday, August 18th at The Ritz Carlton in San Juan, Puerto Rico. Steed presents the session: “Microbial and Environmental Monitoring Risk Assessment.” Marsha’s presentation addresses microbial and Environmental Monitoring (“EM”) risk assessment tools and methods for all types of manufacturing processes: aseptic processing, terminal sterilization, low bioburden and non-sterile.
July 26, 2017
Marc Glogovsky has joined ValSource as a Senior Consultant. Marc has 19 years’ industry experience, specializing in aseptic operations, quality control and environmental monitoring. His work at ValSource addresses common misunderstandings in the development and implementation of sound, globally accepted risk based environmental monitoring programs.
“Applying results and information obtained from various microbiology assays can be confusing,” Marc comments. “ValSource affords me myriad opportunities to alleviate customers’ misconceptions and misunderstandings, ultimately improving their overall quality and production methodologies.”
Prior to joining ValSource, Marc managed Veltek Associates, Inc.’s environmental monitoring division where he was responsible for global portfolio management, technical support and product distribution….
July 11, 2017
Compounding Pharmacy Consultant Christopher J. Smalley is a contributor to the book, A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry. The book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients.
Chris Smalley’s chapter, Identification of Critical Knowledge: Demystifying Knowledge Mapping, provides examples of how companies can map their organizations’ knowledge and assess critical knowledge gaps in order to improve access, flow and reuse of critical knowledge by the people who need it, when they need it….