Companies and professionals working in the QC, QA
departments of the pharma industry are increasingly facing the need to
constantly update themselves and their teams on the various regulatory
requirements, technologies and techniques. This need arises from the desire to
maintain leadership, the requirement to comply with regulations and the most
importantly to meet the quality expectations.
The workshop ”Whispering Microbes and Talking Inspectors
" was held in Hyderabad on 5th and 6th of June 2014.
It was organized by Vienni training and consulting LLP. The workshop aimed at
introducing and educating pharma professionals on how to better manage and
control microbiological issues. The main theme of the workshop was a review of
the misconceptions, chief expectations and monitoring requirements of an
environment monitoring program and data integrity, considering not only the
impact brought by the advances in the technical dimension, but also other
dimensions such as policy, quality, regulatory and technical aspects.
The workshop was opened to only 27 selected participants,
representing 9 companies from across the country via systematic selection
process.
The workshop was inaugurated by a thought-provoking discussions
on the most common misconceptions that professionals have while they design an
EMP. The workshop took off in the right earnest, with a presentation on the
handling of microbiological data deviations. A very engaging case study served
as a bridge between the two presentations and kept the participants keenly
focused on the subject at hand.
A subsequent presentation on “Assessing Integrity of
Microbiological Data: In-spector’s expectations and how to reach compliance”
provided serious inputs to enable better assessment. Discussions after the talk
showed the increased understanding that the participants gained. Most feedback
suggested that the participants were now better equipped to evaluate data and
certainly were better at understanding inspectors expectations.
The workshop continued on Day 2 with a discussion on
“Performing self inspections of microbiology laboratory: Tricks and Traps”.
Scaling up operations is always needs a great deal of experience and the very
next topic was “Laboratory Sterilization - Cycle design and qualification:
Operational differences between laboratory and production sterilization “. And
the day two ended with a talk on Designing of Microbiological tests for complex
formulations.
At the conclusion
of the workshop there was a general agreement that the event was a perfect fit
for the professionals’ training needs. Given the increased use of technologies,
need for regulatory compliance and the rush to the market, there was a request
from all participants to continue to organize more such workshops. Finally, it
was proposed to establish an open forum under the Vienni umbrella, to continue
the discussion and the exchange of ideas. In that spirit, a linked-in group has
been started for the participants.
