Category: Uncategorized

Assessing Environmental and Critical Utilities Excursions

Quality Risk Management and Microbiology Consultant Amanda Bishop McFarland has been published by American Pharmaceutical Review (“APR”). APR is the leading review journal for business and technology in the pharmaceutical industry throughout North America. McFarland’s cover feature, “Risk-Based Microbial Assessment Tool (R-MAT): A Novel Approach to Assessing Environmental and Critical Utilities Excursions” describes how the R-MAT can both assist in determining the appropriate actions for addressing excursions and help organizations develop a proactive means of preventing excursions.

“Despite the opportunity to employ risk management, some firms are still struggling with using risk-based methods when it comes to environmental monitoring and critical utilities excursions,” McFarland says….

View Post

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….

View Post

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.  …

View Post

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….

View Post

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….

View Post

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….

View Post

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….

View Post

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….

View Post

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….

View Post

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.  …

View Post