ISPE Experts Participate in Center for Food & Drug Inspection (CFDI) GMP Inspectors Training Program
Training new recruits is something the Center for Food and Drug Inspection (CFDI) takes seriously. The Chinese agency has steadily increased its international inspection coverage over the last five years, and the number of National GMP Inspectors has rapidly risen to 649. The agency recently invited Charles Tong, PhD, Executive Council Member of ISPE China’s Board, to lead a one-day training session on process development and validation as part of an eight-day training event. More than 40 new National GMP Inspectors attended the session held in December 2016 at the Ritan Hotel’s conference center in Beijing.
“Training participants found the session helped them understand important principles and learn practical applications related to process validation in a lifecycle approach,” said Dr Tong.
The training session was one-day in-class training program that uses material adapted from the ISPE “Practical Implementation of Process Validation Lifecycle Approach” training course. The program, conducted in English, consists of a lecture and presentation followed by a question-and-answer session.
“This program strengthens the collaboration between ISPE and CFDI, and furthers ISPE’s goal of sharing knowledge on topics important to the industry and the regulatory agencies,” said ISPE CEO and President John E. Bournas.
Before traveling to the 2019 ISPE Annual Meeting & Expo in Las Vegas, the ISPE Japan Affiliate held its annual phar-maceutical plant tour over five days (21–25 October), visiting two plants in Los Angeles, one in Boston, and one in In-dianapolis.
The 2019 ISPE Max Seales Yonker Member of the Year Award was presented to Charlie Wakeham, a data integrity and compliance specialist based in Sydney, Australia, who has played an instrumental role in the development of GAMP®.