Posted & filed under Articles, Company Announcements.

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 Knowledgesmalley book 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. Smalley commented, “Tacit knowledge—knowledge based on memory—contributes to making better pharmaceuticals and helps to explain why an operator trained in the procedures and following the batch record might not be successful in manufacturing a satisfactory batch.” He continued, “The challenge for organizations is to capture tacit knowledge and make it institutional knowledge by incorporating it into batch records updates and procedures.”

Chris Smalley works with pharmacists to design, build and operate Smalley Chris 2010 copycompliant compounding facilities. He recently retired from Merck, where he worked for five years on innovative implementation and validation, including Single Use Systems globally. Previously, he was Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier as a plant manger for the Johnson & Johnson family of companies.

Chris has been a member of the Parenteral Drug Association (“PDA”) Board of Directors, as well as a member of the PDA Science Advisory Board. Currently, he is a member of the ISPE Disposables CoP. His chapter for A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry is available at www.crcpress.com.

Posted & filed under Articles.

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.

pharmaceuticalonline“Shipping validation, though generally simpler than manufacturing process validation, still warrants an effective and efficient approach to assure product quality and availability,” Hanff said. “A right-sized approach to pharma product shipping validation can deliver both effectiveness and efficiency.”

Christopher M. Hanff has over 18 years of experience in biopharmaceutical development, operations, lean manufacturing, and quality systems. He contributed to and led a number of projects ranging from suite start-ups, design-construction, and commercialization efforts, to pharmaceutical manufacturing management. He has extensive experience in essential quality management systems oversight, design, and remediation, including under FDA sanctioned consent decree. Hanff continues to lead ValSource’s efforts, advocating for greater efficiency and effectiveness in all areas of Active Transport Validation.

Posted & filed under Company Announcements.

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. “By understanding clients’ organizational goals and needs, we focus on a solution that moves from simple training to true learning results. Our emphasis is not just ‘what’ to do but also the ‘why’ – the underlying rationales.”

JLV+Headshot+Aug+2016Since 1992, Dr. Vesper has been creating instructional solutions for the pharmaceutical and health-care industries using video and computer technologies as more effective and efficient delivery media. He presents papers and workshops at various international technical and professional meetings. He has taught at the PDA Training and Research Institute and works as an advisor/consultant for the World Health Organization’s (“WHO”) Vaccine Quality/Global Learning Opportunities group, designing and facilitating workshops.

Prior to joining ValSource, Dr. Vesper established and was president of the firm, LearningPlus, Inc. He also worked 11 years at Eli Lilly and Company in Indianapolis, Indiana. As an author, Dr. Vesper has written five books, including GMP in Practice, co-published by Parenteral Drug Association (“PDA”) and DHI Books; the 4th Edition was released in 2011. Risk Assessment and Risk Management for the Pharmaceutical Industry was published by PDA and DHI Books in 2006. He has authored or co-authored more than 20 journal articles. 

Dr. Vesper earned a BS in Biology from Wheaton (Illinois) College, a Masters of Public Health (MPH) from the University of Michigan School of Public Health, and a PhD in Education from Murdoch University in Perth, Western Australia.

Posted & filed under Company Announcements, Events.

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. 54-5, PDA Quality Risk Management for the Design, Qualification and Operation of Manufacturing Systems. Attendees will apply the principles outlined in TR 54-5 with the guidance of the primary authors and regulators.

“By design, this workshop is highly interactive,” comments ValSource Chief Operating Officer Hal Baseman. “Attendees will participate in breakout sessions and encourage dialogue on such important topics as the use of QRM approaches for the characterization of critical aspects of system design, the qualification of those systems and the integration of QRM principles into the pharmaceutical manufacturing system.”

During breakout sessions, attendees will perform a hands-on risk assessment of a given process and use the information to develop lifecycle-focused quality system plans and approaches for commissioning qualification and validation, change control, deviation management, CAPA and investigations. After the breakout sessions, the groups will reconvene to share results, ask questions and identify remaining challenges.

Project engineers, project managers, commissioning and validation professionals, quality assurance personnel, auditors and decision makers are encouraged to attend. For more information and to register, visit www.pda.org/2017QRM or call 301-656-5900 ext. 115.

Posted & filed under Articles.

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. “Our expertise and knowledge must be made available and solicited to learn from each other so that the most well-informed decisions are reached.”

Read the full article here

 

Christopher CHanff HeadshotM. Hanff has over 18 years of experience in biopharmaceutical development, operations, lean manufacturing, and quality systems. He has worked on and led a number of projects ranging from suite start-ups, design-construction, and commercialization efforts, to pharmaceutical manufacturing management. He has extensive experience in essential quality management systems oversight, design, and remediation, including under FDA sanctioned consent decree. Hanff will continue to lead ValSource’s efforts, advocating for greater efficiency and effectiveness in all areas of Active Transport Validation.

Posted & filed under Company Announcements.

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”).

Kelly Waldron“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. Kelly has authored numerous industry and academic papers on QRM and conducts much of her academic research in collaboration with the Parenteral Drug Association (“PDA”). She is an active member of the PDA Task Force, “QRM in Design, Commissioning, and Qualification.” Kelly Waldron holds a BA in Biology from Boston University and an MBA in Pharmaceutical Management from Fairleigh Dickinson University. She is currently pursuing a PhD in Quality Risk Management from the Dublin Institute of Technology, Ireland.

Posted & filed under Company Announcements.

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.

McFarland Headshot“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. “At my core, I am a risk management advocate. I am passionate about bringing people together to execute risk management more efficiently. For me, that’s what this is all about.”

McFarland specializes in the creation and implementation of risk management programs and in the development of custom risk-based strategies. In 2015, she presented at the IVT’s Quality Risk Management Series and IVT’s Microbiology Week. She has a Bachelors of Science (Entomology) and a Masters of Science in Mycology, both from the University of Florida. Amanda is an active member of the PDA and a faculty member of the PDA’s Quality Risk Management and Risk-Based Qualification of Sterile Drug Product Manufacturing Systems training series.

Posted & filed under Company Announcements.

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.

“Changes to these ISO standards will impact the way companies perform cleanroom classification activities,” Hardiman said. “Our strategies offer a clear path to compliance.”

MarshaHardiman is a recognized expert in risk-based environmental monitoring and microbiological contamination control with over 20 years of experience in the pharmaceutical and medical device industries. Marsha has extensive experience in Quality and Microbiology. Her leadership experience includes global experience with manufacturing locations in North and South America, Europe and Asia. Marsha has strong quality auditing experience for requirements to FDA, EMEA, ISO and other national regulatory requirements. Her experience includes being a notified body inspector for ISO/CE marking. Marsha Hardiman is actively involved in the PDA and is a member of the Scientific Advisory Board (SAB), the Education Advisory Board (EAB) and the 2017 Microbiology Program Planning Committee.

Posted & filed under Company Announcements.

Lorianne (“Lori”) Richter has joined ValSource as a Senior Consultant. Lori brings 17 years of experience and expertise in biotechnology manufacturing processlori-headshot-copyes, 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. Prior to ValSource, Lori spent three years with Genentech, serving as Site Risk Manager for the Genentech Vacaville site where she designed and implemented a business/strategic risk program and business continuity program. She has also served in previous roles that included being on a team that developed and deployed a Quality Risk Management program across the Roche Pharmaceutical Division. This included developing tools, templates, and training materials, and integrating QRM into Quality Systems. She is currently a team member of the Parenteral Drug Association Task Force, “QRM in Design, Commissioning, and Qualification.”

Posted & filed under Company Announcements.

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.

amanda-mcfarland“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. “Our strategies alleviate this struggle and offer a clear way forward.”

McFarland specializes in the creation and implementation of risk management programs and in the development of custom risk-based strategies. In 2015, she presented at the IVT’s Quality Risk Management Series and IVT’s Microbiology Week. She has a Bachelors of Science (Entomology) and a Masters of Science in Mycology, both from the University of Florida. Amanda is an active member of the PDA and a faculty member of the PDA’s Quality Risk Management and Risk-Based Qualification of Sterile Drug Product Manufacturing Systems training series.