PDA Letter Article

Spotlight on PDA Education in India

by Biny Joseph, PDA India Chapter, Eduoriens Skill Development, and David Talmage, PDA, Inc.

The Indian pharmaceutical industry by volume is the third largest in the world. PDA has been supporting the industry through various scientific discussion platforms and forums in India since 2013 through the PDA India Chapter.

An in-depth survey of the Indian pharmaceutical industry in 2018 showed there was great interest in high-quality training in areas critical to global manufacturing and compliance. In response to the survey results, PDA Education, in collaboration with Eduoriens Skill Development LLP, introduced its courses to enhance the skills of Indian pharmaceutical professionals.

Between 2019 and 2021, close to 1700 professionals were trained by PDA Education in India.

Eduoriens Skill Development recognized the industry’s growing demand for more skilled workers and upgraded the curriculum of pharmaceutical studies to meet industry prerequisites. They first created a scientific body of 65 pharmaceutical professionals, the Board of Studies (BoS), who evaluated the range of skills required by managers and the operational and supervisory team members.

The BoS worked diligently to identify the necessary learning requirements for different level positions and customized practical hands-on learning plans for each. To ensure the training’s effectiveness, it was led by three professionals with extensive knowledge of the industry and education: Prashant Sharma (Chief Technical Officer, Zydus Lifesciences), Tina Morris, PhD (Executive Director, American Association of Pharmaceutical Scientists), and David Talmage (V, Education, PDA).

To maximize the efficiency of the operational team, BoS engaged subject matter experts from the Indian pharmaceutical industry to be qualified as local PDA Education tutors. These tutors were carefully selected and trained using a tutor development program to prepare them for the training courses.

Course Faculty

  • Prashant Sharma, Chief Technical Officer, Zydus Group
  • Dr. Akash Chaurasia, BITS Pilani
  • Ivy Louis, Founder Director, Vienni Training & Consulting LLP
  • Anish Sanghvi, Chief Technical Officer
  • David Talmage, VP, PDA Education
  • Dr. Tina Morris, Executive Director, American Association of Pharmaceutical Scientists (AAPS)
  • Dr. Satya Moturi, VP, Quality, Biological E Ltd.
  • Krishna Venkatesh, Operations Head – Injectables, Dr. Reddy’s Laboratories
  • Ranjit Menon, Site Head, Dr. Reddy’s Laboratories
  • Raju Gujare, Sr. VP Operations & Technical Services, Microlabs Ltd.
  • Sandeep Raktate, Sr. VP, Cipla Ltd.
  • D. B. Shridhar, Sr. VP, MS&T, Zydus Lifesciences Ltd.
  • Nandu Kagvate, President & Founder, PharmaQual
  • Nitin Tiwari, Sr. VP, Global Quality Operation, Endo Pharma
  • Ravi Menon, Director, Serum Institute of India
  • Sanjay Kumar Jain, PhD, President, Amneal Pharmaceuticals India
  • Pradipta Swain, Sr. VP, Operations, Biological E
  • Dr. Rustom Mpdy, Sr. VP, Head R & D, Sun pharmaceuticals
  • Vishal Sharma, President, PDA India Chapter
  • Sanjay Sinha

A pilot program was conducted to test the effectiveness of virtual sessions, which was the first time to be used to train local tutors of the operational team. These virtual sessions were well received and paved the way for in-person learning modules. Hands-on sessions began in April 2022 with a group of 30 enthusiastic participants at the Brooks Learning Centre in Bangalore, a facility with laboratories, a shop floor and classrooms.

The Brooks team all standing together in front of the glass doors to the event
The program participants standing on a brick patio outside of the event

PDA Education courses have given a new dimension to the learning experience in India. Not only did the courses make it easier for participants to understand the concepts and science behind unit operations, but they also focused on how to implement what was learned. Toward the end of the course, participants held a one-on-one discussion with their managers to discuss an implementation plan.

One student commented, “I never knew training could be conducted like this and we could enjoy the learning process so much!” During a follow-up call, the student’s manager said that the “practical sessions helped [my] participant to understand the science behind activities and also helped him to remember the learnings well.”

Attendees seated in a presentation being addressed by members of the team

Several of the Indian SMEs spoke highly of the initiative, expressing how they thought the hands-on PDA Education training would benefit the industry. Kenalee Patel, a tutor for the “Microbial Limit Test” course, said:

Skilled manpower is the foundation of any industry. The same also applies to the pharmaceutical industry. Training the manpower for company-specific processes and regulatory compliance is an important and time-consuming task. The hands-on PDA Education training program provides the platform for the industry to get their employees trained by experts and technology partners. This will help in developing the skill/knowledge of trainees, which in turn will help in developing their scientific reasoning abilities, increasing understanding of the complexity and ambiguity of the empirical work they perform in their organizations.

Sanjay Jain, PhD, who is BoS member “Water Systems” tutor (President, Amneal Pharmaceuticals, India), said this about the training:

It is a good initiative and approach of the PDA Education for hands-on training for their pharmaceutical industry colleagues. Before making the final training modules, each topic was discussed among the council members, and detailed user requirement specifications were prepared at different levels (Operator, Supervisor and Manager). Theoretical training along with practical demonstration with case studies is beneficial to the trainees.

The support supplied by technology providers of the pharmaceuticals and biologics industry during these learning programs greatly enhanced the experiments conducted in the laboratory to better explain scientific principles.

An attendee in a labcoat, hairnet, mask, and gloves sits at an isolation station with media and petri dishes
Attendees in labcoats, hairnets, and masks watch a demonstration of surface cleaning

Aditya Sharma (Director, Process Solution Life Science-India Region, Merck) thought the major highlight of these sessions was the hands-on practical session. He felt that the “initiative is beneficial for the industry in skill enhancement and development of industry talent. This will also transform the field of life sciences by advancing science and technology with a focus on education and thought leadership.”

Another technology partner leader, Rahul Warke (Director, Himedia Laboratories), shared that “PDA Education has provided a unique platform that makes science-based learning simple, effective and practical to bring into practice in [the participants’] routine work. This will help them be more aware of the work they do and also make them more ready to face any regulatory interactions.”

Participants were trained at three levels:

  • Level 1 – Shop Floor Operators
  • Level 2 – Supervisors
  • Level 3 – Senior Managers

Between April and August 2022, PDA Education completed training sessions for 322 professionals: Level 1 sessions began in April, Level 2 sessions began in July and Level 3 sessions started in August. During the Level 3 session, the group received an intense three-day training on environmental monitoring with Marc Glogovsky from ValSource Inc.

Many more hands-on sessions are scheduled through March 2023. To learn more about the PDA Education initiative in India, contact [email protected].