Contract Pharma 2011 Recap
Last week was the 10th Annual Contract Pharma Contracting and Outsourcing Conference in New Brunswick, NJ. This was Vision Point Systems’ second year attending the event which is designed for decision-makers and is devoted to outsourcing in the Pharmaceutical and Biopharmaceutical industries. The event featured over 150 exhibitors in the tabletop exhibition showcasing capabilities in the manufacturing, packaging, laboratory and clinical areas of the industry.
Notable speakers included Douglas Kovacs, Consumer Safety Officer for the FDA NJ District. His presentation focused on Process Validation Guidance. Although the address focused on manufacturing (giving examples of FDA expectations on sampling raw materials), this was interesting because there are many common threads in managing quality of a manufactured product and managing quality in a data processing system.
Also speaking was John Avellanet, Director of Cerulean Associates. His talk centered on the FDA’s expectations on “Virtual Suppliers.” John has written in the past about FDA 21 CFR Part 11 guidance on electronic records and signatures as well.
The exhibitors/vendors were very eager to engage with conference attendees to learn about the attendees’ business needs, discuss the vendor’s competencies, and explore opportunities to work together. Contracting and outsourcing in a safety critical environment like pharmaceutical requires a great deal of trust and professionalism. Events like this are great to remind prospective vendors about what it takes to establish the relationships required to build this foundation.