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The Quarterly Consult
Your Pathway to Compliance
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We hope your New Year is off to a great start!
For Complya Consulting, 2015 was a year of growth. We added talented consultants to our network, established partnerships to expand our service offerings, and increased our internal support team.
We look forward to another year of success and growth in 2016!
Sincerely,
Complya Consulting Grou
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Featured Article
Clinical Materials: Changes and Comparability
By Jilla K. Boulas,
Senior Regulatory Affairs Consultant
The development of a drug product is a long and costly journey which starts from basic research and moves down a path that requires much development, and takes turns at points where decisions have to be made. At the end of this path, one hopes to arrive at a safe and effective product for the treatment or prevention of a disease or condition. While commercialization of the product is one possible happy end to this long journey, one also has to be prepared to reach a potential dead end where the "no go" decision has to be made...
About the Author
Jilla K. Boulas is a Senior Regulatory Consultant with Complya Consulting Group, LLC, in Woburn, Massachusetts involved in assisting/consulting clients in the design and implementation of CMC strategies throughout the lifecycle of pharmaceutical and biopharmaceutical medicinal products.
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Consultant Spotlight
This quarter we're pleased to introduce you to Complya Senior Quality Assurance Consultant, Brett Vengroff!
Brett Vengroff has 19 years of Quality Assurance experience in the biopharmaceutical industry and embraces a hands on approach to consulting. He is a well accomplished industry professional with an expertise in GCP, GLP, and GMP compliance and an eye toward supplier quality.
Prior to consulting, Brett served as Associate Director of Clinical Quality Assurance for CombinatoRx and as Quality Assurance Manager for both Vertex Pharmaceuticals, and ArQule Inc. In these positions Brett successfully established and maintained quality assurance systems worldwide, designed and improved business process workflows, training programs and performance management systems.
Brett is a senior member of the American Society for Quality and graduated from the Greater Boston Executive Program in Business and Management at the Massachusetts Institute of Technology. When not consulting, Brett manages multifamily real estate for partners and individual investors.
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Complya Consulting Group's team of Quality Assurance and Regulatory Affairs consultants includes nearly 50 active consultants along with a network of dozens of talented consultants who work with Complya on a per-project basis. For more information on our team, contact us at [email protected]
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Join Our Team!
Complya is always seeking talented, self-motivated consultants with expertise in Quality Assurance and Regulatory Affairs.
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Consult Complya
How do I manage my service providers more effectively?
Managing CROs, CMOs and material suppliers can be a daunting task, however it is critical to your Quality Management Program.
Conducting vendor qualification and routine audits can be a time consuming process for busy quality professionals. As a result, many companies consider using a full-time third party expert to oversee their CMOs, CROs, and suppliers. This saves time and provides an unbiased expert analysis of your partners.
However, if you already have a Quality Auditing Group, there are a number of ways to utilize a part-time consultant. The consultant can provide audit support, or generate
the auditing schedule by making risk based decisions on which suppliers to audit and when. In addition, this consultant can also manage and negotiate quality agreements with the suppliers. Again, saving time and providing expert support to your quality group.
For more information on managing your CROs/CMOs, or to ask your own question, contact us today at [email protected]
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Featured Events
Joint NERCSQA-NEPDA Dinner Meeting
March 9th, Woburn, MA
*Event Sponsor
Annual Lab Productivity Micro-Conference
March 24th, Cambridge, MA
SQA Annual Meeting
April 3-8th, Grapevine, TX
*Visit Complya at Booth 201
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