Need of the hours and FDA is watching for your Training to staff on Data Integrity, 21 CFR part 11 Compliance and Computer Systems validation. If they are train they perform better Review and approval mechanism.
We can help you train your staff in best possible way to compliance. If you count cost per person it is the lowest and Training is world class. We can organize two or three days class room session as per your choice. Most big and Medium corporate are booking slots of multiple Training.
Specilized training on GAMP, 21 CFR Part 11, CSV, Data Integrity & Risk Assessment for your Staff. Basics to Advance.
After studying market Cap of IPCA, Wockhardt, Zydus, Dr Reddy’s and Sun following is the conclusion
Zydus Loss 6000 Cr in Market cap after warning
IPCA down since long
Lupin Lost 400 Rs per share on adverse news of FDA
Natco lost 90 Rs in a day per share
Wockhardt Lost heavily.
Cadila Pharma in remediation mode at Ankleshwar Plant.
Emcure Had a Bad effect.
SUN Also Loss huge amount
Dr Reddy’s Lost Rs 1400 per share in a week resulting in a great loss of market cap.
Selmer Research and GVK Bio things are shocking.
Cost of Remediation action is separate so Cost of Non Compliance is very high.
Why CEOS have to study Data Integrity and 21 CFR part 11 Compliance as well as Software Validation.
Decided to book a slot in History of Indian Software Validation When ever it is written. 10 year dedicated services in Software validation – Training and 20 year with Automation and our working style has made us legend in Software validation. We can safeguard our customers in Data Integrity, 21 CFR part 11 Compliance, Risk Assessment, GAMP5, Annex 11, Computer Systems Validation and many more areas. We train your staff also very well. We let you know Why Validation is needed? How it is linked to growth of each Employee and the company. As well as Comfort for Global Earth.
Without proactive compliance, 21 cfr training, good risk assessment, Gamp5 knowledge pharma Company stock price will tumble for sure, do not know when? So It is better to be ready and not getting a chance Rather than getting a chance and not being ready.
Feeling Happy to see that most good Pharma Companies have started careful evaluation of software validation consultants. They realise that cost based evaluation can close the shutter of the pharmaceutical company or the consultant can not support (expertise issue). Software validation consultant and Data Integrity and compliance trainer is your heart and mind. Select and use them carefully. Good consultants are getting over booked. Once you loose the contract with a good consultant , new contract always comes at a premium.
I strongly suggest following
Now so many pharma company Started realizing importance of good Software validation consultant. Consultant charges are only 2-5% and get you 1000% more in earning. They safeguard your data, process and Quality. They train your people too.
All pharma company MD, CEO, CIO, CFO should have a meet with Partner , CEO of Good Software validation company and make a good bond so they are always protected.
All Limited Companies should have one independent director who is expert in Software Validation and Data Integrity. Having such independent Director post itself will increase your market cap by few hundred crores. If he starts working the profit will multiply 10 to 1000 times in future.
Sub: Training on GAMP5, Why Validation, 21 CFR part 11 Compliance, Risk Assessment , FDA Role , Key Points of CSV
Training program devised for the pharma people to get the insight of Why Validation ?
FDA Role
Why Validation?
Benefits of Validation
GAMP5
21 CFR part 11 compliance
Annex 11
Data integrity
Computer Systems Validation Deliverables
Teaching in most easy and understandable way. 10 years of dedicated exprience of CSV given during this two days training or three days workshops.
Please wrote to infraics@yahoo.com or call 9825047998
Dear Sir,
Thank you very much for the courtesy extended to us during our visit to discuss about the Software validation. We are glad to quote for the training to your Senior, middle and junior management staff at different plant location on Quality aspect like Data Integrity, GAMP5, 21 CFR Part 11 compliance, Computer Systems Validation, ICH Q9 Risk Assessment and benefit of Quality production. We are a leading quality consulting firm with a goal to benefit Indian company achieve excellence in regulatory compliance. We work in India, China, USA, France, Iceland, Muscat and many other part of the world. We work with No.1 Automation company of the world Emerson Process management China, No 1 Raman Spectrometer Company of Japan Horiba Scientific, No.1 Retail Pharma chain of Muscat Muscat Pharmaceuticals. Morton Groves in USA.
As a special measure we have started the training session at customers site explaining why regulatory requirement needs to be followed. It increases awareness and hence quality production and profit. One has to join this session sooner or later. The price is also kept attractive and you can have more people joining the course and per person cost will work out to be very low.
We try to cover maximum topics but it depends on understanding of the people
You can have multiple people attend the training so per person cost will be very low and no travelling or other charges will incur.
Once you know why of the Validation or any work you can do lot more. (This training if taken from Foreign party can cost somewhere between 15 Lac)
I have been taking training at China, Muscat, India and IT companies Like MphesiS and HCL Technologies, Clinigene (Biocon Group Company) for their Global Pharma Account team. I have also trained team of Alembic (Multiple Session) , Cipla, Sentiss Pharma, Sci Tech Laboratories, Naproad Life Sciences, Piramal Glass, Mylan, Watson, UCB, Dr. Reddys’ Lab, Emerson Process Technologies, Lupin, Glenmark, S Kant Health Care, Medispray, Alkem, Nootan Pharma,Sun Pharma, MphesiS, Piramal Health Care, J B Chemicals, Aventis, Wockhardt, Degina Medical Devices, and Many More..
Even Open to all training conducted at Location like Mumbai, Chandigarh and Hyderabad where people from all company jointly took the training.
Emerson Process Management Shanghai , China and Many other companies
Wang Ban Group Interior Of China for 250 or so Delegates
Muscat Pharmaceuticals Oman Muscat
Assuring you of best services and support. Thanking you.
For Infra Control Systems
Kalpesh Vaghela
98250 47998
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