Safis Solutions, LLC  is pleased to announce that Todd Hubbard and Mark Vare, R.Ph., RAC have joined our business development team, effective June 20. "We were delighted to have found not just one, but two individuals with such extensive qualifications and experience in the industry," said John Nadelin, Director of Regulatory and Compliance Services. "Mark and Todd will be instrumental as we continue to grow our business, expand our service portfolio, and ultimately deliver value-added services to our clients."  

Mark Vare, Director of Business Development, has 20 years' experience in the life sciences industry, including regulatory affairs, field sales, marketing, supply chain logistics, and recall operations. His work has encompassed recall preparedness training, specialized marketing programs, and compliance reviews. Mark is the author of "How to Work With the FDA. Tips From the Experts. How to Deal with a Recall". Mark holds a Bachelor of Arts in Political Science from Indiana University and a Bachelor of Science in Pharmacy from Butler University.

Todd Hubbard, IT Services Sales Executive, brings over 21 years of experience helping his clients achieve success in their projects.His areas of expertise include Information Technology, Government Solutions, Business Process Management, Manufacturing, and Sales Management.  Todd will focus his efforts at Safis on helping organizations meet both business and regulatory needs through the use of IT Services.Todd resides in Fishers with his family and is a graduate of the Indiana University Kelley School of Business.

  Authored by Dawn Schofield        

The Rx-360 consortium is a non-profit organization of volunteers from the Pharmaceutical and Biotech industry; with membership open to pharmaceutical and biotechnology companies; and suppliers of raw materials, components, excipients, and active pharmaceutical ingredients. The Consortium's primary directive is to enhance the security of the pharmaceutical supply chain, and assure the quality and authenticity of the products moving through the supply chain. To this end, their mission is to create and monitor a global quality system by adopting standards and best practices for the supply chain, supporting technology developments for supply-chain security, monitoring the supply chain, and developing shared audit programs.   

The initial pilot  program is currently underway; including audits of API, excipients, and basic chemicals/raw materials suppliers throughout North America, Europe and Asia.  After undergoing an extensive and comprehensive qualification process, Safis Solutions was selected as the auditing firm to conduct the site audits for the North American leg of the Joint Auditing Pilot.

As part of their mission of developing shared audit programs, Rx 360 has proposed two models; the Shared Audit model, and the Joint Audit model.  In the Shared Audit model, consortium members may submit and pull, from a shared database, reports from audits that have already been conducted, either by member companies, or a third party.  This model leverages information that is already available; however, as suppliers determine which audits and responses they wish to share, the information may lack objectivity.

The Rx-360 Joint Auditing model involves a joint decision among a number of consortium members to audit a supplier. A qualified Rx-360 audit team then completes a comprehensive audit according to the Rx 360 auditing process and guidelines, and the site and the members who requested the audit receive the audit report.  Furthermore, the audit report is placed into an electronic database that other consortium members may access, and utilize in lieu of conducting their own on-site audit.  This approach has the potential to significantly reduce the number of audits at supplier sites, while increasing the effectiveness of the audits performed.

Ping Poulsen, President and CEO of Safis Solutions, states "This program offers tremendous potential benefit to both pharmaceutical and biotech companies and their suppliers through potential reduction in the number of audits hosted and conducted."  Dawn Schofield, Compliance Advisor at Safis and Rx 360 auditor, emphasized the importance of a performing a thorough assessment. "In order to make broad utility (of these audits) possible, the scope must be very comprehensive; encompassing the site's entire Quality Management System and representative processes for the products of interest to the membership.  The level of detail in the reports must demonstrate that each element was effectively assessed."

For more information on the Rx 360 Consortium, membership, its mission and current activities, please visit theRx 360 website.