ScientiaBio

“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.