News

Aseptic and Sterile Processing: Control, Compliance and Future Trends

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….

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ValSource Consultant Marsha Steed Presents on Environmental Monitoring Risk Assessment

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.

“Contamination control begins with good design coupled with risk assessment and risk mitigation,” Steed said….

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Marc Glogovsky Joins ValSource

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….

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A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

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….

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Pinpointing Supply Chain Risk Through Line-Of-Sight Shipping Validation

Senior Validation and Risk Consultant Christopher M. Hanff has been published by Pharmaceutical Online. Pharmaceutical Online provides the pharmaceutical manufacturing and packaging industry with exclusive and actionable information to help industry members tackle the challenge of bringing life-saving and life-improving therapies to market. Hanff’s article, “Pinpointing Supply Chain Risk Through Line-Of-Sight Shipping Validation” addresses how shipping validation can act as a vehicle, delivering improvement throughout the entire pharmaceutical quality system.

“Shipping validation, though generally simpler than manufacturing process validation, still warrants an effective and efficient approach to assure product quality and availability,” Hanff said….

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Director James Vesper Joins ValSource

Dr. James Vesper has joined ValSource as Director of Learning Solutions. Vesper brings more than 35 years experience in designing and developing instructional courses and workshops for the pharmaceutical and biopharma industries. Under Dr. Vesper’s leadership, ValSource’s Learning Solutions Group addresses Good Manufacturing Practice (“GMP”) requirements and expectations. Combining quality content, innovative instructional tools, and real-world situations, the Learning Solutions Group delivers clients practical knowledge to meet current demands and prepare for future challenges.

“Our learning solutions are the efficient platform for acquiring, sharing, sustaining, and expanding practical expertise,” Vesper comments….

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ValSource Experts Share PDA’s Newest Approach to Risk-Based Thinking

Four ValSource consultants are featured presenters and moderators at the Parenteral Drug Association (“PDA”) Quality Risk Management for Manufacturing Systems Workshop. The workshop takes place June 19-20 at Hyatt Centric Chicago Magnificent Mile in Chicago, IL. ValSource’s Hal Baseman, Lori Richter, Christopher Smalley and Kelly Waldron, together with key industry and regulatory leaders, will share their expert opinions on the value and role of quality risk management in the modern manufacturing system lifecycle.

The Workshop is based on PDA’s practical and effective approaches to using QRM for key decision making in the lifecycle of manufacturing systems, which will be published in the upcoming PDA Technical Report No.

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Translate Your Knowledge into Reliability

ValSource Senior Validation and Risk Consultant Christopher M. Hanff has been published by The PDA Letter. The Letter is the Parenteral Drug Administration’s membership magazine covering the science, technology, and regulation behind the manufacturing of sterile injectables.  Hanff’s article, “Translate Your Knowledge into Reliability,” sets a foundational understanding of knowledge management and focuses on opportunities for meaningful, practical knowledge transfer.

 

“Whatever we know individually, it’s not valuable to others if it’s not available to others,” Hanff says in the article….

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Kelly Waldron Joins ValSource

Kelly Waldron has joined North America’s largest independent process control and compliance consulting and service company as a Senior Consultant. Kelly brings extensive experience and expertise in various quality and risk-related functions in the biopharmaceutical industry, focusing the past ten years on the development and implementation of innovative approaches to Quality Risk Management (“QRM”).

“The value our processes brings to clients and, in turn, their patients, is game changing,” Kelly comments. “Whether it’s targeting improvements at a small portion of the quality system, or seeing it through a complete evolution, I help ValSource customers transform how they work.”

Prior to joining ValSource, Kelly managed Global Quality Risk Management and Design Control at Sanofi….

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ValSource Consultant Amanda Bishop McFarland to Co-Lead PDA Quality Risk Management Interest Group

Quality Risk Management and Microbiology Consultant Amanda Bishop McFarland is the new co-leader of the Parenteral Drug Association (“PDA”) Quality Risk Management (“QRM”) Interest Group. The QRM Interest Group provides PDA members a forum to learn, promote, and share best practices that incorporate and advance QRM methods in their respective organizations. McFarland is responsible for providing focus, structure, consistency and direction to PDA QRM activities, conferences, courses and publications.

“It’s an honor to have this opportunity to collaborate with industry leaders I wouldn’t otherwise collaborate with, who are using QRM to better their environments,” McFarland said….

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