News

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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ValSource Consultant Marsha Hardiman Presents on Environmental Monitoring

ValSource Senior Consultant Marsha Hardiman is a featured speaker at the Parenteral Drug Association (“PDA”) Southern California Chapter Aseptic Processing and Contamination Control Symposium. The
symposium takes place Thursday, March 14th at Crown Plaza Costa Mesa in Costa Mesa, CA. Hardiman presents the session: “Creating Your Monitoring Plan and Risk Assessment for ISO 14644-1 and 14644-2.” Marsha’s presentation addresses the changes to ISO 14644 Parts 1 and 2 and focuses on the factors to consider when performing risk assessment and creating a monitoring plan….

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Lorianne Richter Joins ValSource

Lorianne (“Lori”) Richter has joined ValSource as a Senior Consultant. Lori brings 17 years of experience and expertise in biotechnology manufacturing processes, quality systems, and business process development.

“I am passionate about developing a pragmatic approach to Quality Risk Management,” Lori comments. “ValSource affords me the perfect opportunity to share my passion and experience on a team, one that is influencing how the industry enhances Quality Management Systems to drive continuous improvement.”

Lori holds a Microbiology degree from California State University, Chico….

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ValSource Consultant Amanda Bishop McFarland Presents on Quality Risk Management

Quality Risk Management and Microbiology Consultant Amanda Bishop McFarland is a featured speaker at the Parenteral Drug Association Southeast Chapter 2016 Fall Conference. The conference takes place Thursday, November 3rd at Brier Creek Country Club in Raleigh, NC. McFarland presents the session: “Implementing a Robust Quality Risk Management Program.” Her presentation addresses ways to evaluate current risk management programs and identifies elements to consider when implementing new, or enhancing existing, risk management programs.

“More than a decade after ICH Q9 Quality Risk Management was published, areas of our industry are still struggling with navigating the guidance and identifying the appropriate ways to integrate risk management into their businesses,” McFarland said. …

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ValSource Chief Operating Officer Hal Baseman Co-Chair

ValSource, LLC (“ValSource”), announced, Hal Baseman as Co-Chair of the Parenteral Drug Association (“PDA”) Aseptic Processing Task Force will present on subjects related to Aseptic Process design and simulation at upcoming PDA workshops in Dublin Ireland on October 5-6, 2016 and Arlington VA on 25-26, 2016. The PDA convened the task force revised the 2003 PDA-published paper, “Points to Consider for Aseptic Processing.” Originally drafted as a commentary on the U.S. FDA guidance on GMPs for aseptic processing, the 2003 document was rendered obsolete by considerable changes within the industry resulting in additional knowledge, including new regulatory guidance in this area….

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