One of the
biggest challenges facing Pharma manufacturers in India is the lack of focus on
compliance procedures and processes. This comes in the wake of scrutiny by the US
Food and Drug Administration (FDA) and action taken against few leading Indian
drug manufacturers.
So, before
the US health regulators crack the whip again, it’s pertinent for the Pharma
Industry in India to take cues and work towards compliance and address quality
issues.
At this crucial
juncture, UL India is happy to join hands with the Indian Drug Manufacturers’
Association (IDMA) and host ‘India Pharma Regulatory & Compliance summit-2014'.
The theme of the conference is 'Sustaining Regulatory Compliance in the Pharma Industry'.
The theme of the conference is 'Sustaining Regulatory Compliance in the Pharma Industry'.
Importance of addressing Compliance
Issues
It’s time
Indian Pharma focuses on FDA’s observations on quality and compliance. As more
inspection on quality is forthcoming from the regulator, there’s no other way
for investors and other stakeholders but to raise the bar on quality.
UL paving way for - Compliance | Regulation |
Engagement
Very
recently UL has been awarded a further extension of CRADA (Corporate Research
and Development Agreement). This gives us more opportunities to continue the
commitment towards GMP, cGMP, and US FDA inspector training, utilizing the best
in class technical expertise.
Applying Global Learning to India
This summit
is an opportunity for Pharma executives, professionals and stakeholders to
address the quality issues addressed by regulatory agencies. The summit, India
Pharma Regulatory & Compliance summit- 2014', will address all these topics
and also give you an opportunity on know how industry is gearing towards the
new market realities.
So, the next
time FDA shows up for an unannounced inspection, we want you to be ready with well-written
procedures and answers that meet the regulatory requirements. This is your
chance to start working towards complete compliance.
For more information please visit the website
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