ScientiaBio

ScientiaBio updated their website address.

“The capacity to learn is a gift, the ability to learn is a skill, the willingness to learn is a choice” ....whether a professional working from office or working from home, learning should continues...
As we complete 2 days virtual LIVE training course on "GMP Auditor / Lead Auditor", my sincere thanks to all participants Ratish Acharya, Arutla venkateshwarlu, Nilesh Thorat, Himanshu Dutt, Suresh Chandran Manoj Kumar, Vibha for making it very interactive and knowledge sharing session with our trainer G Sundar whose vast experience in pharma audits always enriches the participants.

I am glad to announce our next learning session for the month of May, 2020
1. Statistical Interpretations for Clinical / Medical Professionals with Bhaswati Mukherjee
( 2nd week of May) Details in the link : https://lnkd.in/gaQhAyq

2. Advance training on How to Document Audit Observations CAPA and its Compliance with Mr Sundar 29th & 30th May
Details in the link : https://lnkd.in/fFsb3z6

Golden opportunity to undergo GMP Auditor / Lead Auditor training virtual LIVE with highly accomplished auditor G Sundar.

Date : 29th and 30th April, 2020

Duration : 6 hours

Time : 6pm to 9 pm IST (GMT +5.30 hours)

Fees : Only 50 USD ( including course material and certificate),

Open the link for details https://sites.google.com/site/scientiabiomasterclass/quality

or email us [email protected] for details

Quality Course type : Training on basics, regulations, best practices with standard case studies illustrating common errors, pitfalls, regulatory findings or comments.

Stay safe, stay at home, learn / re-learn new skill set. ScientiaBio announces online LIVE class on SDTM & ADaM on 2nd and 3rd week of April. Details in the link : https://sites.google.com/site/scientiabiomasterclass/cdisc
Write to us at [email protected] or call us at +91 9945318216 / +91 80 41692453 for any query.

Last week of registration : GMP Auditor / Lead Auditor Training ; 29th January & Quality Risk Assessment ICH Q9 & WHO TRS -981 (QRM) Training; 28th January, Bangalore

Details in the link : http://www.scientiabio.com/upcoming_workshop.html

Contact : +91 9945318216 / Email : [email protected]

It’s our constant endeavour to provide service with best quality. We are always thankful to our expert consultant whom we collaborate for training and consultancy services. This time we are grateful to Mr G Sundar for delivering such excellent training on GMP Lead Auditor training. When 100% of the participants give the feedback as “very good”, it’s re-assurance of our quality. Thank you all participants for making it so interactive.

Today’s pharmaceutical auditor needs auditing skills, technical skills and up to date knowledge of the latest regulatory requirements. Do you want to perform audits for your organisation? If so, you are an ambassador for your company, and so it is essential that you perform these audits professionally. Our 1 day program on GMP Auditor/ Lead Auditor training course on 7th December at Mumbai covers how to effectively plan, perform, report and follow-up pharmaceutical audits against a range of pharmaceutical standards, including GMP, CAPA, OOS, OOT & QRM-PQS systems, API GMP, auditing suppliers / contractors also includes data integrity audits.
Details in the link below http://www.scientiabio.com/upcoming_workshop.html



Corrective and Preventive actions (CAPA) are key to an effective quality management system. And the key to an effective CAPA system is to know how to do an in-depth root cause analysis. In our one day workshop on "Conducting Robust Root Cause Analysis for CAPA" get trained by expert quality consultant G Sundar on tools and techniques for doing an effective root cause analysis.
Date : 6th December, Location : Hotel Suba International, Mumbai
Contact : +91 80 4169 2453 / +91 9945318216
Email : [email protected]

Dear Pharma Quality Professionals, we are quite sure that Corrective Action Preventive Action (CAPA ) systems already in place in your organisation. But is there a CAPA culture in your organisation or is it only in document ?
CAPA process deficiencies have long been the number one Good Manufacturing Practice (GMP) violation cited in FDA 483 and Warning Letters for pharma companies.
Attend our master class (case study based) with Mr G Sundar to achieve excellence in cGMP audits and compliance.

When : 20th September, Friday

Where : At your office or home

Medium : Online LIVE, limited only for 10 candidates, session includes complete Q&A session by all participants, includes complete training material and certificate

Time : 2.30pm to 8pm IST / 5am to 10.30am EST / 10am to 3.30pm UK

Details of the agenda and other details in the link : https://lnkd.in/fNMysk3

Quality (Focused discussions related to recent regulatory audits trend concerns and how to face International cGMP Regulatory Audit; Document Audit Observations CAPA & its enhanced Report to Regulatory exploration towards potential substantial cGMP Compliance )

Writing Risk Management Plans & Drafting Efficient Risk Minimisation Measures for Pharmacovigilance.

In the EU and in many other countries, all companies are required to provide risk management plans (RMPs) for every new product. RMPs are also required for generic products. Risk minimisation measures must be accurately presented in the RMPs. Additional Pharmacovigilance activities and/or additional risk minimisation measures are required for new products, and almost always required for biosimilars and hybrid applications. In addition, there may be requirements for modified RMPs throughout the lifecycle of a product.

Are you and your organisation doing the RMP in the right way ? Join our Master Class by Dr Deepa Arora to know better ? Details in the link : https://sites.google.com/site/scientiabiomasterclass/home

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“The more people that participate in clinical trial, the faster we can answer the critical questions that will lead us to more treatment and prevention options for all cancers “ .—NIH, USA

On the occasion of May 20th, International Clinical Trial day, lets us create awareness, understand, educate, appreciate positive aspects of Clinical Trial. Trial and testing of fighter pilot to medicine everything comes with certain negative aspects. But lets us not highlight those negative aspects which in turn undermine potential positive impact that each trial can create among millions of patients.

Government of Malaysia is doing great job by promoting Malaysia as preferred destination for clinical trial. We are glad to be back to Kuala Lumpur to conduct our workshop on Clinical Trial Management in compliance with ICH-GCP E6R2 addendum. We are thankful to all participants and of course our trainer Anirban Roy Chowdhury for making it highly interactive and knowledge sharing. Next up is destination Singapore on this topic on 10th & 11th July. Please visit our website www.scientiabio.com for more details.

Workshop on
Clinical Trial Patient Recruitment and Retention Strategies on
9th May, 2019 at Novotel KLCC, Kuala Lumpur

Workshop on
Clinical Trial Management and Oversight in compliance with ICH-GCP E6R2 addendum on 7th and 8th May,Kuala Lumpur

“Excellence is an art won by training and habituation”…we are delighted with the feedback of our workshop “Managing Clinical Trial in India:essentials for Sponsors, CROs and Investigators to abide by the recent regulatory challenges” held at Bengaluru on 1st and 2nd March. We are glad partnering with industry expert Anirban Roy Chowdhury to deliver the course. Please join in our next workshops on “Clinical Trial Management and Oversight in Compliance with ICH-GCP E6(R2) addendum” and “Patient Recruitment & Retention Strategies” at Kuala Lumpur & Singapore. Details available in the link : http://www.scientiabio.com/upcoming_workshop.html

Scientiabio

Our 1st workshop of 2019 : Two days workshop titled
"Managing Clinical Trials in India: Essentials for Sponsors, CROs and Investigators to abide by the recent regulatory changes" on 1st and 2nd March, 2019 at Hotel Trinity Isle, Bangalore

The workshop topics will include:

* Regulatory changes in India since 2013
* Overview of ICH-GCP R6(E2) amendment
* Site recruitment and selection
* Informed Consent & AV Recording
* Safety reporting and managing compensation in Clinical Trial
* Proactive risk management
* Quality management in clinical trial
* CRO oversight


The workshop will be based on practical exercises and real life case studies

For more information and registration please contact us at +91 80 4169 2453 / [email protected] and follow the link below for details:
http://www.scientiabio.com/upcoming_workshop.html

scientiabio.com

Scientiabio

Our 1st workshop of 2019 : Two days workshop titled
"Managing Clinical Trials in India: Essentials for Sponsors, CROs and Investigators to abide by the recent regulatory changes" on 1st and 2nd March, 2019 at Hotel Trinity Isle, Bangalore

The workshop topics will include:

* Regulatory changes in India since 2013
* Overview of ICH-GCP R6(E2) amendment
* Site recruitment and selection
* Informed Consent & AV Recording
* Safety reporting and managing compensation in Clinical Trial
* Proactive risk management
* Quality management in clinical trial
* CRO oversight


The workshop will be based on practical exercises and real life case studies

For more information and registration please contact us at +91 80 4169 2453 / [email protected] and follow the link below for details:
http://www.scientiabio.com/upcoming_workshop.html

scientiabio.com Managing Clinical Trial in India:essentials for Sponsors, CROs and Investigators to abide by the recent regulatory challenges

May your home and life sparkle with peace and prosperity today and always...Wish you a Happy Diwali

If you are a small or medium size / Bio-pharmaceutical / / Device organisation with very limited budget of clinical trial of your product, partner with ScientiaBio for cost effective & high quality ( From SAP to Randomisation to Programming and report generation ) and Medical Writing work. Please reach us at +91 80 4169 2453 or [email protected] for any query.

If you are a small or medium size Pharmaceutical / Bio-pharmaceutical / Biotechnology / Medical Device organisation with very limited budget of clinical trial of your product, partner with ScientiaBio for cost effective & high quality Statistical ( From SAP to Randomisation to Programming and report generation ) and Medical Writing work. Please reach us at +91 80 4169 2453 or [email protected] for any query.

Online LIVE training on "Biostatistics using R : Clinical Trial Applications". This course covers the
implementation in R of statistical procedure
important for the clinical trial statistician. Write to us at [email protected] or call us at +91 80 4169 2453 for query or registration.

Scientiabio

It's our great pleasure to inform about two days professional development workshop on Crafting Sound Medical Affairs Professionals in India - Cultivating Core Competencies and Mindset on 8th & 9th March, 2018 at Bangalore. Course is focused on Customised learning experiences through a variety of learning interactions and tools; knowledge and information sharing; individual & group exercise & presentation;learning material related reading, discussion, debate, evaluation and analysis. Email : [email protected]; contact : +91 80 4169 2453; more details in the link : http://www.scientiabio.com/upcoming_workshop.html

scientiabio.com

Application of Regression Analysis using R

Online LIVE training on Application of Regression Analysis using R; Date : 24th & 25th January ; Time : 7pm to 9pm IST (GMT +5.30 hours); write to us at [email protected] for enquiry / registration. Please check the link for the details of the course : https://www.linkedin.com/pulse/application-regression-analysis-using-r-monisha-hajra/?published=t

linkedin.com Date : 24th & 25th January ; Time : 7pm to 9pm IST (GMT +5.30 hours) Mode of Training : Online LIVE Course Objective : The course will be focused on

Biding adieu to 2017 and ushering in 2018 from ScientiaBio

Workshop On Clinical Project Management; 6th and 7th November; Johannesburg

We are glad to announce our first workshop at Johannesburg, South Africa; Clinical Project Management workshop
6th & 7th November & Applied Statistics for Clinical Researcher workshop on 8th November. Write to us at [email protected] or call us at +27 82 3300725 for any query. Please find the details of the workshop in the link below : http://www.scientiabio.com/upcoming_workshop.html

Investigator Initiated Clinical Trial Workshop, August,2017; Singapore

We are glad to announce ScientiaBio along with QuintilesIMS,Singapore & Singapore Clinical Reserach Institute (SCRI) organising workshop on Basic and Advance Investigator Initiated Trials on 30th & 31st August, Singapore. Reach us at [email protected] or +91 80 4169 2453 for any query/registration. Workshop is also supported by Zuellig Pharma. Details of the workshop available in the link http://www.scientiabio.com/upcoming_workshop.html

lnkd.in

Workshop on CMC-Regulatory Requirements of Biopharmaceutical, Biosimilars and Vaccines; Bangalore

Scientiabio

Workshop on CMC-Current Requirements for , & ; 28th and 29th July, 2017 at IRIS Business Hotel, Bangalore. Please find details in the link http://www.scientiabio.com/upcoming_workshop.html ; send mail [email protected] for query / registration. Early bird registration last date 30th June.

scientiabio.com