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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Senior Consultant Igor Gorsky Presents on Rapid Micro Detection INTERPHEX 2016

ValSource announced Senior Consultant Igor Gorsky is a featured speaker at the 2016 International Pharmaceutical Expo (“INTERPHEX”). The Expo takes place April 26-28 at the Javits Convention Center in New York City. April 26th Igor presents the session: “Rapid Micro Detection – Part of Risk Based Lifecycle for Pharma/Biopharma Production for XXI Century.” The session aims to aid implementers of Instant Micro Testing instrumentation in their understanding of new technology, as well as provide succinct description of the main aspects of rapid microbial testing implementation….

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ValSource Senior Consultant Christopher M. Hanff Joins PDA Letter Editorial Committee

ValSource announced Senior Consultant Christopher M. Hanff has been accepted as a member of the PDA Letter Editorial Committee (“PLEC”) for 2016-2017. The PDA Letter is the Parenteral Drug Administration’s (“PDA”) membership magazine covering the science, technology and regulation behind the manufacturing of sterile injectables. The PLEC provides editorial oversight for all feature articles supplied by PDA members, industry and regulatory experts and PDA staff.

Mr. Hanff has over 16 years of experience in biopharmaceutical operations and quality systems….

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ValSource Senior Consultant Christopher M. Hanff Named ASQ-Certified Manager

ValSource announced, Senior Consultant Christopher M. Hanff has been named an ASQ-Certified Manager of Quality/Organizational Excellence (“ASQ CMQ/OE”). This achievement demonstrates Mr. Hanff’s receipt of significant professional recognition, indicating proficiency in and comprehension of quality management principles and practices. The ASQ CMQ/OE is a professional who leads and champions process-improvement initiatives and must have 10 years of work experience related to the body of knowledge.

Mr. Hanff has over 16 years of experience in biopharmaceutical operations and quality systems….

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ValSource Consultant David Hussong Recognized by Parenteral Drug Administration

ValSource announced, Senior Microbiology and Regulatory Consultant David (”Dave”) Hussong, Ph.D. has been recognized by the Parenteral Drug Administration (“PDA”) for his contribution to the evolution of the Annual Global Conference on Pharmaceutical Microbiology. As it celebrates 10 years of networking, sharing and learning from experts and professionals in pharmaceutical manufacturing, PDA recognizes Dave’s work for the significant role he has played in helping make these annual conferences so successful.

A formal presentation of the award will take place at the PDA 10th Annual Global Conference on Pharmaceutical Microbiology Gala Dinner on Tuesday, October 20th at 6:00 p.m….

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ValSource Senior Director of Consulting Dr. Michael Long Leads Parenteral Drug Association Applied Statistics Interest Group

ValSource announced, Senior Director of Consulting Mr. Michael Long to Lead the Parenteral Drug Association’s (“PDA”) new Applied Statistics Interest Group.  The Applied Statistics Interest Group is concerned with the creation, development and manufacture of pharmaceutical products using statistical tools from starting materials to finished product.  From development through manufacture and end of use, its focus encompasses the entire lifecycle. Its seeks to improve the understanding of issues for applied statistics within the scientific, technical and pharmaceutical community, while providing an environment where PDA membership has a resource to explore and understand tools being employed by experienced users….

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ValSource Announces Geographic Regions Hyper Local Focus Provides National Coverage & Enables Rapid Deployment

ValSource announced, it has completed structure of seven national geographic regions. The company now maintains a dedicated presence in a regional footprint that includes the entire United States. ValSource employs more full time validation professionals than any other qualified resource in each of its seven regions. These hyper-localized hubs provide readily and easily mobilized talent and resources.

ValSource Regions

Southern Region – encompassing states and areas south of the Carolinas: Georgia, Alabama, Mississippi, Louisiana, Florida, and Puerto Rico….

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Consultant Amanda Bishop McFarland Joins ValSource

ValSource announced, Amanda Bishop McFarland has joined North America’s largest independent validation services company as a consultant. Prior to ValSource, Amanda spent five years with Genzyme, most recently serving as Senior Continuous Process Improvement Analyst.

Amanda McFarland comments, “ValSource provides me the perfect opportunity to share my QRM and Microbiology knowledge to influence change in our industry.” Amanda specializes in quality risk management, program implementation and partnership development and contamination control.

Amanda McFarland earned both her Bachelor of Science in Entomology and her Master of Science in Mycology and Air Quality from the University of Florida….

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ValSource Consultant Bob Wissert Speaker and Panelist 2015 Ultrapure Water Pharma Annual Conference

ValSource announced Consultant Bob Wissert (“Bob”), is a speaker and panelist at the 2015 Ultrapure Water Pharma Annual Conference. The conference takes place, June 2nd-3rd at the Double Tree Hotel in Bethesda, Maryland. On June 2nd Bob is a panelist on the discussion of Life Cycle Approaches for Pharma Water Systems, examining issues that arise with aging pharmaceutical water systems.  On June 3rd, he is presenting the update for the PDA Water Interest Group – Using Resources to Share and Learn in the Pharmaceutical

The 2015 UPW Pharma Conference aims to dispel the water treatment myths and to serve as a forum for educating delegates on new developments that impact the future of pharmaceutical water treatment.  …

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