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. This democratic forum represents the views and interests of a diverse group of members who meet once a year for two days during the APhA Annual Meeting and Exposition to establish broad policy on health care, medication use and professional and governance matters. In addition, delegates provide input throughout the year on policy topics under consideration by the Association.
Chris Smalley works with pharmacists to design, build and operate compliant 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 APhA delegate term runs June 2017 – May 2018.
Reach Chris at firstname.lastname@example.org.
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. Renewed emphasis is placed upon assurance and controls, including leveraging the best available technologies and conducting thorough, science-based risk assessments of processes.”
Aseptic and Sterile Processing: Control, Compliance and Future Trends, edited by Tim Sandle and Edward C. Tidswell, is available here from the PDA Bookstore. Among the subjects covered are contamination risks, regulations, bioburden control, endotoxin control, water systems, depyrogenation, filtration, microbial contamination risks to cleanrooms, environmental monitoring, aseptic process simulations, single-use disposable technology, disinfection, sterility testing, cleanroom operator controls, risk assessment, human error and rapid methods.
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. “Our strategies ensure microbial risk assessments evaluate all materials and equipment used in the manufacturing process so that risks can be understood and mitigated when possible. Likewise, we encourage EM risk assessments be performed to ensure that EM sample locations are selected based on risk.”
Steed 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 with 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 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.
Marsha can be reached at email@example.com.
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. He has written a number of publications related to rapid microbiology, environmental monitoring, Mycoplasma and MALDI-TOF microbial identification. A Parenteral Drug Association (“PDA”) member for more than fifteen years, Marc is on PDA’s Education Advisory Board, is a faculty advisor at PDA-TRI and has served on a number of PDA Technical Report committees. Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.
Marc can be reached at firstname.lastname@example.org.
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. 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 compliant 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.
Chris can be reached at email@example.com.
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. “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.
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.”
Since 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.
James can be reached at firstname.lastname@example.org.
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.
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.”
Christopher M. 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.
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. 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.
Kelly can be reached at email@example.com.