News

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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ValSource Dispels Pharma Dogma as Myth

ValSource, LLC (“ValSource”), this week made a bold declaration for the pharmaceutical validation industry. ValSource Chief Operating Officer Hal Baseman comments, “We debunk the longstanding and misguided myth that there must be a negative relationship between cost and quality.” He went on to say, “Increased quality does not necessarily result in increased cost and decreased profit.  When process risks are properly identified and addressed, using sound scientific methods, profit should follow increased quality. This distinction is critical for the pharmaceutical industry considering valuing investments of time, talent and financial resources.”

Baseman’s declaration, is illustrated in a series of articles on Line of Sight, Risk Evaluation Methods published in the PDA Letter (June 2016 edition) is a result of ValSource’s more than 20 years experience understanding clients’ products and processes.  …

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Senior Director Fred Hammonds Joins ValSource

ValSource today announced Fred Hammonds has joined as a Senior Director. Hammonds brings more than 30 years experience in the safety field. He now leads ValSource’s Construction and Site Safety Services department. Under Hammonds’ leadership, ValSource’s Safety Solutions Group acts proactively to secure worksites, schedule field audits and train and resource qualified safety professionals at its clients’ facilities worldwide. Hammonds also leads safety training for ValSource’s more than 200 employees.

ValSource Founder David Calvaresi commented, “ValSource has always been committed to safety….

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Use of Detectability In Risk Assessments

ValSource announced Quality Risk Management and Microbiology Consultant Amanda Bishop McFarland has been published by the Institute of Validation Technology (“IVT”) Network. IVT Network is a trusted source for life science validation and compliance professionals to access the most current and relevant industry and regulatory knowledge. McFarland’s article, “Considerations Regarding the Use of Detectability In Risk Assessments,” explores potential pitfalls associated with considering detectability within the risk management framework.

“The purpose of considering detection in any scenario is to ensure that potential or actual failures can be identified with enough time to take action before the user is adversely affected,” she said….

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Line-of-Sight Technique Illuminates Dark Corner—Shipping Validation

ValSource announced, Senior Validation and Risk Consultant Christopher M. Hanff is leading efforts to address what he and his colleagues have identified as critical Active Transport Validation needs and deficiencies within the pharmaceutical, biotechnology and medical device industries.

Speaking to engaged and receptive audiences, Hanff recently addressed Interphex Puerto Rico, PDA, and several other venues on the topic. “Shipping and its validation remain largely undervalued and highly misunderstood.” Hanff continued, “It’s difficult to reconcile how this last, and therefore, one of the most important links in the supply chain, continually merits so little attention.” What’s certain is how detrimental failure to properly execute and validate shipping can be….

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