Biotrains.com

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Our Workshop Leader for #Lyotalk Europe

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LyoTalk Europe 2018

Lyotalk is Europe largest annual conference on Lyophilization/Freeze Drying. Lyotalk attracts gathering from of 150+ experts from pharma, biotech and Academia from Europe and rest of the world for 2 days of learning of latest technology and networking, discovering new opportunities and partnerships.

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The Data Integrity

9 – 10  November 2017  9 am to 5 pm

Mumbai, India

Description:-

Data Integrity is a fundamental element of a (Bio) pharmaceutical industry to ensure quality and safety of drugs. It’s a major global concern of health authorities and (Bio) Pharma companies. Although Data Integrity is not a new issue, it has gain alarming attention in last few years due to FDA’s and MHRA’s scrutiny and a number product detention, import alerts, suspension of marketing authorization and warning letter issued to companies found non-compliant. Although Data integrity is a global issue it is a burning topic in Asia- Pacific, specifically China and India. According to Indian ministry, India has the second-largest number of manufacturing facilities outside of the US (523 as of March 2014) registered with the US FDA. Furthermore, India’s drug exports to the US have risen from US$1.25 billion in FY10 to US$3.45 billion in FY14.2.

Website:-http://thedataintegrity.com/

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The Data Integrity

6 – 7 November 2017 9 am to 5 pm

Hyderabad, India

Description:- Data Integrity is a fundamental element of a (Bio) pharmaceutical industry to ensure quality and safety of drugs. It’s a major global concern of health authorities and (Bio) Pharma companies. Although Data Integrity is not a new issue, it has gain alarming attention in last few years due to FDA’s and MHRA’s scrutiny and a number product detention, import alerts, suspension of marketing authorization and warning letter issued to companies found non-compliant. Although Data integrity is a global issue it is a burning topic in Asia- Pacific, specifically China and India. According to Indian ministry, India has the second-largest number of manufacturing facilities outside of the US (523 as of March 2014) registered with the US FDA. Furthermore, India’s drug exports to the US have risen from US$1.25 billion in FY10 to US$3.45 billion in FY14.2.

Website:-http://thedataintegrity.com/

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Pharma Quality System

12-13 Oct 2017 Mumbai

9 am to 5 pm

Description:- A Pharmaceutical Quality System is mandatory to comply with EU GMP and the manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different departments

Website:-http://pqs.biotrains.com/

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COMPUTER SYSTEM VALIDATION

12-13th Oct 2017 Mumbai

9 am to 5 pm 

Description:-In the biopharmaceutical space, regulatory compliance is a part of a firm’s business thinking. Regulatory agencies worldwide such as GCC, MHRA, USFDA, EMA, TGA, ANVISA etc. are harmonizing the regulations to assist the industry in complying with them. To keep the industry abreact with the changing regulations, Biotrains has designed this workshop to examine the key local and global regulatory developments affecting GCC regulations, Module 3, and their evolution in 2017 and beyond.This workshop is for novices, advanced users, senior management and others who use computer systems for laboratories, clinical trials, manufacturing, quality, validation and IT system vendors. It addresses GCC Module 3 topics such as Pharmaceutical Quality Systems Elements (PQSE), Data Integrity elements, Corrective and Preventive Action (CAPA) and Computer Systems Validation (CSV).The workshop is designed to provide attendees with the knowledge and working skills on complying with the requirements with GCC regulations Module 3 including Data Integrity, which is the current, focus regulatory audits worldwide.

Website:-csvworkshop.com/

[biotrains]

Pharma Quality System event

9-10 Oct 2017 Time:-9am to 5pm

Description:-A Pharmaceutical Quality System is mandatory to comply with EU GMP and the manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different departments

Website:-http://pqs.biotrains.com/

[biotrains]

Computer System Validation  event

9-10 Oct 2017 Time:-9AM to 5PM

Description:-In the biopharmaceutical space, regulatory compliance is a part of a firm’s business thinking. Regulatory agencies worldwide such as GCC, MHRA, USFDA, EMA, TGA, ANVISA etc. are harmonizing the regulations to assist the industry in complying with them. To keep the industry abreact with the changing regulations, Biotrains has designed this workshop to examine the key local and global regulatory developments affecting GCC regulations, Module 3, and their evolution in 2017 and beyond.This workshop is for novices, advanced users, senior management and others who use computer systems for laboratories, clinical trials, manufacturing, quality, validation and IT system vendors. It addresses GCC Module 3 topics such as Pharmaceutical Quality Systems Elements (PQSE), Data Integrity elements, Corrective and Preventive Action (CAPA) and Computer Systems Validation (CSV).The workshop is designed to provide attendees with the knowledge and working skills on complying with the requirements with GCC regulations Module 3 including Data Integrity, which is the current, focus regulatory audits worldwide.

Website:-http://csvworkshop.com/

http://www.biotrains.com/

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Lyotalk India event

22-23 feb 2018 9AM TO 5 PM

Description:-The conference attracts gathering professionals & experts from pharma, biotech and Academia from Asia pacific and rest of the world for 2 days of learning of latest technology and networking, discovering new opportunities and partnerships. The event covers a wide spectrum from formulation, Development, Production, manufacturing and regulatory affairs topics such formulation strategies, Scale-up, cycle development & optimization, Regulatory compliance,  Quality by Design (QbD) ,  PAT process design, Ice Nucleation, Case studies & troubleshooting, New developments in freeze drying, Process development for generics, proteins, biologics and vaccines. Lyotalk 2018 is a two day program that features presentations, case studies, interactive round tables, panel discussion and workshop facilitated by industry experts. The first day covers talks and presentations and day 2 is dedicated to workshops/training

Website:-http://lyotalk.com/

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QBD-PAT  event

Description:-QbD & PAT conference will bring together participants from industry, academia and regulatory creating invaluable opportunity to discuss the recent developments, future trends, challenges and Solutions for development & Manufacturing of Pharmaceutical & Biotechnology products.The conference will focus on discussing the existing challenges and explore practical applications related to drug development, manufacturing and regulatory. Its a 2 day program which will include presentations, talks, case studies, panel & Round-table discussions from industry leaders, solution providers and academia.The Day 2 will be dedicated to training/workshop. Below are few benefits of attending our conference.

Date 16-17 Nov 2017 Time:-9 AM TO 5 PM

Website:-http://qbd-pat.com

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9 – 10 November 2017  9 am to 5 pm

“Para-Injecto 2017 - The world of Parenterals and Injectables” conference and training, will be unveiling the challenges and exploring solutions in Formulation & Development, Manufacturing, packaging, Quality and Regulatory aspects of Parenterals and Injectables. The Para-injecto conference is a perfect platform to showcase and discuss with the industry leaders the recent advances, latest technology and alternative strategies that are flexible and cost-effective to develop and manufacture Parenterals & Injectables. Renowed Industry Leaders, Regulatory Experts, Academia, Solutions providers and Manufacturers from Asia and across the globe will be a part of this mega conference and will be sharing their experience of Parenterals and Injectables There will be ample of opportunity to meet & interact with speakers, industry peers, regulators, Exhibitors and industry leaders during the Networking breaks and interactive discussions.

Website:-http://parainjecto.com/india/index.php

[biotrains]

QbD & PAT - Building Quality in Development & Manufacturing 2017

QbD & PAT conference will bring together participants from industry, academia and regulatory creating invaluable opportunity to discuss the recent developments, future trends, challenges and Solutions for development & Manufacturing of Pharmaceutical & Biotechnology products.The conference will focus on discussing the existing challenges and explore practical applications related to drug development, manufacturing and regulatory. Its a 2 day program which will include presentations, talks, case studies, panel & Round-table discussions from industry leaders, solution providers and academia.

The Day 2 will be dedicated to training/workshop. Below are few benefits of attending our conference.

Building Quality

Best Practices

For more details please visit our website http://www.qbd-pat.com

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Join us for PHARMA CMI, India: A Leading Competitive and Market Intelligence conference – The only gathering of senior level professionals from Pharma, Biotech and Device professionals looking for the latest updates and learn about the most critical and relevant issues facing the competitive & Market Intelligence community. The conference theme is “Driving the future of Pharma Business through Competitive & Market Intelligence”. The conference aims to understand how the pharmaceutical & Biotech companies, marketing, competitive intelligence, strategic and operational divisions are staying updated with accurate information about their competitors in today’s dynamic Market to keep themselves ahead and deliver business value. It will also discuss major issues and unveil solutions to the challenges faced by today’s CI professionals in the industry. Listen to the dynamic leaders and industry expert discussing and presenting case studies for best practices. Pharma CMI also gives an opportunity to meet and network with Industry thought leaders & peers within Competitive Intelligence Industry in one location.

If you are interested to learn how to utilize competitive & market Intelligence to keep yourself ahead in 2017 and beyond to boost your business – Pharma CMI is a MUST attend EVENT !

For More details visit www.pharmacmi.com

[biotrains]

Meet our Chairperson Dr Gaurav Thukral on Home Healthcare Summit & Awards 2017 held on 20-21 April 2017 Mumbai. For more details download Brochure: http://www.homehealthcaresummit.com/brochure-download.php

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Our Recent Successful Conference & Workshop QbD & PAT 16-17 March 2017

[biotrains]

Here is an opportunity for Speaking on our upcoming HHS & Awards 20-21 April Mumbai. If anyone interested feels free to contact Rachna Tiwari Conference Manager [email protected] [phone] For More details Download Brochure: http://www.homehealthcaresummit.com/brochure-download.php

[biotrains]

21 CFR PART 11 - COMPUTER SYSTEM VALIDATION • r/science

1 points and 0 comments so far on reddit

Proactive GCC Quality Compliance workshop: Module 3

 COURSE SUMMARY

In the biopharmaceutical space, regulatory compliance is a part of a firm’s business thinking.  Regulatory agencies worldwide such as GCC, MHRA, USFDA, EMA, TGA, ANVISA etc. are harmonizing the regulations to assist the industry in complying with them.  To keep the industry abreact with the changing regulations, Biotrains and US based global compliance expert Chiinmoy Roy have designed this workshop to examine the key local and global regulatory developments affecting GCC regulations, Module 3, and their evolution in 2017 and beyond.

This workshop is for novices, advanced users, senior management and others who use computer systems for laboratories, clinical trials, manufacturing, quality, validation and IT system vendors. It addresses GCC Module 3 topics such as Pharmaceutical Quality Systems Elements (PQSE), Data Integrity elements, Corrective and Preventive Action (CAPA) and Computer Systems Validation (CSV).  Chinmoy Roy, who is conducting this workshop, has a proven record of accomplishment in implementing over 200 systems and successfully obtaining “fit for use” certification.

The workshop is designed to provide attendees with the knowledge and working skills on complying with the requirements with GCC regulations Module 3 including Data Integrity, which is the current, focus regulatory audits worldwide.