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IDMA, NSF to commence second series of APPQM virtually in Jan 2021

The programme is designed in five modules and will have access to ex regulators from the US FDA, UK MHRA etc.

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The Indian Drug Manufacturers’ Association (IDMA), in collaboration with the NSF International, a global public health and safety organisation will commence the second series of ‘Advanced Program in Pharmaceutical Quality Management’ (APPQM) from January 2021. It is a virtual training programme which contains five modules and the fee for the entire programme is Rs 3,15,000.

S M Mudda, Program Director, APPQM informed, “After the successful completion of the first series, the APPQM second series was launched in March, however, due to the COVID-19 pandemic and restrictions, the programme could not be started. But now we are happy to begin the virtual education programme of APPQM which contains five modules. It is paced with a gap of 6-8 weeks between each module. Now, understanding the present scenario and required measures, we are aiming to begin the second series of APPQM in January 2021.”

He elaborated, “To ensure the efficiency of the programme the seats are restricted to 25 and the eligible candidates are required to be in a functional leadership/second-level leadership positions with an experience of 8-10 years. The next-gen leaders with a business background are also considered, based on the benefit derived to nine such delegates of the first series.”

Stressing upon the need for such a programme, Mudda pointed out, “The COVID-19 pandemic has created unique challenges as well as opportunities for the pharma industry. In the absence of any regulatory inspections happening until quarter III of 2021 and reduced oversight by the corporate QA functions due to travel restrictions, there is an urgent need to create a strong leadership at the site for ensuring an ongoing implementation and monitoring compliance with the quality systems.”

“This responsibility now rests on the shoulders of the site teams lead by the functional heads of manufacturing, quality control and quality assurance. Therefore, I strongly recommend the virtual APPQM for those teams for keeping themselves updated with the changing regulatory expectations in the post-COVID-19 phase. And with the help of APPQM programme, it will prepare the industry for enhanced scrutiny by all the leading regulatory agencies once the physical inspections start.”

Reportedly, over 40 delegates attended the first series of APPQM and felt that it is a unique way to impart the world-class regulatory expert knowledge in developing the ‘Change Agents for Quality Excellence’. Participants of the last series highlighted that the APPQM programme has helped in creating in-house “Change Agents” for Quality Excellence by providing skills, knowledge and support to companies. The programme also helps to remain competitive even while complying with the regulatory requirements.

The second series of APPQM programme provides virtual training with live instructor-led virtual classrooms and self-paced learning online (easy to navigate e-learning). The programme is designed with virtually managed break-out rooms. The virtual model will also have access to guest speakers of ex- regulators from the US FDA, UK MHRA etc., to guide the participants.

The APPQM- program modules are:

1) Pharmaceutical quality management systems – Best industry practices

2) Managing change; change control and deviations

3) Human factors–Getting people to follow the rules

4) Transforming data into information – The practical application of statistics to transform your business

5) Quality by Design, process validation and technology transfer

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