HAYWARD, Calif.—October 13, 2014—Pharmatech Associates, a regulatory compliance consultancy serving companies in the pharmaceutical, biotech and medical device industries, will be presenting on a broad range of key topics including facility design and regulatory compliance, Quality by Design (QbD) and the new Process Validation (PV) requirements, at the 2014 International Society for Pharmaceutical Engineering (ISPE) Annual Meeting taking place October 12-15 in Las Vegas.
Bikash Chatterjee, Pharmatech’s President and CSO, will present four education sessions that demonstrate the benefits of new science-based quality- and design concepts and an approach for their practical application, based on Pharmatech’s global experience. The topics include: the Impact of the Drug Quality Security Act (DQSA) and Serialization Requirements; a Design Assessment Model for Pharmaceutical Drug Manufacturing Facilities; a Framework for Implementing QbD to Satisfy the New PV Guidance; and Securing Information as Part of the Global Supply Chain.
The ISPE Annual Meeting features presentations by more than 200 leading global pharmaceutical industry and regulatory experts, and give professionals an opportunity to engage in open dialogue for a better understanding of the industry’s current technical and regulatory challenges. Pharmatech Associates are available to meet at booth T92.
ISPE is the world’s largest not-for-profit society serving pharmaceutical and medical device, engineering, science and manufacturing professionals.
About Pharmatech Associates
Staffed by industry experts, Pharmatech Associates (founded in 1995) provides consulting and services to the regulated life science industry. Pharmatech’s services cover four spheres of technical expertise that are necessary throughout the complete product
development lifecycle: Product and Process Development, Compliance, Regulatory, and Validation. Pharmatech advises clients that range in size from startups to large multi- national corporations on projects in Asia, Europe and North America from its headquarters in the San Francisco Bay Area. www.pharmatechassociates.com
Judy Curtis—SIPR for Pharmatech + 1 650-274-1509