MAY 2, 2001 — TAMPA, FL — The International Society for Pharmaceutical Engineering (ISPE) and EduNeering plan to co-develop an online compliance education program aimed at the healthcare technology industry.
The online courses are being developed with the US Food and Drug Administration through a cooperative research and development agreement. The courses will be used to train FDA inspectors in both district and local offices. The alliance between the ISPE and EduNeering will ensure the course content will meet the needs of the FDA and life sciences industry.
“This is a tremendous opportunity for industry and government to be trained from the same base of information,” said Bob Best, CEO of the ISPE. “We are excited to work with a company as highly regarded as EduNeering is in this area. They had the foresight to partner with the FDA to provide this training and we are honored to work collaboratively with EduNeering and FDA on this.”
The program will launch this Spring and include web-based instruction and valid documentation system. Topics will include: auditing and inspections; electronic signatures and records; quality system regulation; risk management, and; validation.