Clinotek India launches GMP, cGMP, GAMP and CAPA training for Pharma and IT companies

Clinotek India, an award winning training center based in Bangalore, Karnataka with its rich experience is providing much needed training in GMP, cGMP, GAMP and CAPA guidelines for FDA regulated markets to assist both Pharma and IT companies
 
BANGALORE, India - Dec. 21, 2015 - PRLog -- North America is one of the biggest consumers of healthcare products, so it's one of the most lucrative markets for Indian pharmaceutical companies. As per the latest developments, meeting the FDA compliance requirements is becoming a big challenge for pharmaceutical manufacturers exporting the products to FDA regulated markets. Many companies received FDA warnings and notices for lack of compliance measures. In many cases the drugs manufactured under violations of FDA norms have been banned from entering USA market. Such companies pleaded guilty and ended up paying hefty penalty and lost their reputation as well.

Many Indian drug manufacturers though they installed latest equipments and uplifted the standards of the infrastructure, they are still missing one of the most important component - 'training the personnel involved in manufacturing and in-process quality control'. As per the popular statement; it's of very little use if you buy the most modern fighter jet until unless you train the pilots to reap the full potential of such a stellar fighting machine'.

So, one of the key components in meeting the compliance requirements is 'employee training'. Though audits offer little help to maintain compliance, they are insufficient to completely eliminate errors. FDA officials will never rely on any audit reports during their inspections. They always write their own reports based on their own observations and findings. So, it's not a good practice for drug manufacturers to just prepare their employees merely for audits. The best approach is to implement the sense of quality and compliance measures in each and every employee's mind rather than concentrating only on the modern equipments and IT environment.

Clinotek India, an awarded healthcare, pharma and clinical research training provider has successfully trained the stake holders in GMP, cGMP, GAMP and CAPA compliance. Clinotek India's unique and innovative training methodology addresses mainly on bringing the right mindset in employees to help maintain compliance. The cost of non-compliance is shockingly high and the consequences are bitter for drug manufacturers. Many companies who’s drugs have been banned from entering USA markets have lost millions of dollars in penalty, suffered huge losses in stocks that tumbled overnight and the biggest of all was the black mark in their reputation.

Clinotek India's CEO Mr. Nagendrappa M H who is the recipient of many awards in national and international conferences and other platforms for training and education excellence has quoted that 'the mistakes whether big or small, which are preventable with proper training, will be disastrous if ignored even for the biggest manufacturers. It's always better to be safe than sorry'. Employee training is the most important ingredient in successfully maintaining compliance. Training is an art. It's not just about providing them from user manual to read, it's all about involving each and every employee in every aspect of manufacturing. Drug manufacturers and IT companies providing IT solutions for document, process and equipment control can contact Mr. Nagendrappa. M. H, CEO and Lead Trainer through the contact number +91 99452 00555 or on email admin@clinotek.com or by visiting www.clinotek.com.

Contact
Clinotek India, Jayanagar, Bangalore
Mr. Nagendrappa. M. H, CEO and Lead Trainer
***@clinotek.com
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Tags:Gmp, Capa, Fda
Industry:Manufacturing
Location:Bangalore - Karnataka - India
Subject:Services
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