Popular Aseptic Processing Course Gains Enthusiastic New Students in India
In March, three PDA instructors provided PDA’s popular “Aseptic Processing Training Program” course to students in India. Longtime instructors Hal Baseman, Marc Glogovsky and Cheryl Custard enjoyed the opportunity to expand the course within the country as part of PDA’s expanded offerings in the Asia-Pacific region. Hal even returned in May to teach a course on aseptic process simulations!
Below are their thoughts about the experience.
During the first week of May, I had the pleasure of giving back-to-back, two-day “Aseptic Process Simulation” courses in Bangalore, India. The courses were a collaborative effort organized through PDA Education, our Indian training partner, EduOriens Skill Development LLP, and the PDA India Chapter. The classes were attended by approximately 60 senior team members from about a dozen Indian pharmaceutical firms. The course was designed to be interactive, combining lecture with practical group exercises, emphasizing an understanding of why we perform aseptic process simulations, including the objective, benefits and limitations of such studies.
The first day was devoted to providing students with a back-ground in critical thinking and risk-based decision making. It included segments on critical thinking, quality risk management principles and techniques, aseptic process validation and industry and regulatory trends. The second day took the techniques discussed the previous day and used them to define and debate the best practices for aseptic process simulation, media fill study design, implementation and investigation. An advanced course further exploring the use of risk-based techniques and principles to design, perform and address issues resulting from an aseptic process simulation is planned for October.
Teaching and training on behalf of the India Chapter was a tremendous experience! I had the opportunity to work with wonderful folks from varying backgrounds and representing many companies located in India. We had lively debates/discussions, active participation and lots of communication surrounding microbiology, contamination control and environmental monitoring. I quickly discovered that many of the students had similar regulatory concerns, misconceptions surrounding the contamination control system and questions about implementing new technologies.
I am looking forward to offering the advanced portion of our course in September.
I felt very welcomed during our training in India. I quickly realized that the biggest gap between India’s pharmaceutical expectations and those of the United States was that great big ocean between us. The students came with thoughtful insights which led to many side conversations similar to those I have experienced when teaching our training courses in the United States. Despite some cultural differences, I learned that if you put good people with good ideas together under one roof, great things can happen. I am honored to be part of this new PDA Education experience.