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Product – LED Tube Lights World Says Switch off We say switch on Features:- Shape – Retrofit. Complete with adapter. Colour of the Light – Cool White for Work / Writing Places & places to create mesmerizing effect. Electrical saving – 80%. Lower electricity bills. No risk from power fluctuations – 85 volts to 265 volts. Normal life of the lamp – 5.5 to 11 yrs. Beam angle – 180 degrees. Diffused light just like a normal tubelight. Maintenance – extremely low. Almost nil replacement cost as it rarely requires changing. Savings - In electricity & replacement costs - recover the price within the first 3 to 6 months. Time saving - No headaches in running the entire procurement cycle to purchase replacement lights. Light deterioration – around 10% after 3 years use. Regular lamp nearly 50% after 2 to 3 months use. Instant start – Maintenance free. No flickering – No adapters or additional wiring required. Environment friendly – green energy. No UV or IR radiation, No mercury or lead. Low voltage – shock proof. Solid state lighting or light emitting diodes are rugged, sustain power surges, shocks and vibrations, easy to install, lower power consumption.

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Seven Habits of Highly Compliant Pharma Company – Nine days Mastering CSV- GAMP5- CFR part11 and Data Integrity Training Most Pharma 483 and warning letter can be avoided if the Company QA work with Proactive Compliance, Validation as well as periodic review and Internal Audit. Begin with End in mind Like patient Safety, product Quality and Data Integrity. Think Win- Win For patient, Government, Staff and vendors. Sharpen the saw means Training - Retraining First in First out means being real time with Contemporaneous plus many thing. In our two days seminar we try to generate the confidence, faith, belief and conviction in Compliance, along with different guideline like GAMP5, 21 CFR Part11 Compliance, Annex11, Risk Assessment, Data Integrity and make you master in Compliance. Ofcourse you need to remain active and learn all changes later on. You can join our training as a repeat standard member at attractive price Good Compliance has all Quality of “GOD” Generate Operate and Destroy (Data Life Cycle, SDLC Life Talks aboy the same thing) #training #reviews #howto #vendors #patientsafety #riskassessment #dataintegrity #productquality #confidant #gamp #21cfr #internationalauditing

Mastering CSV and Compliance for Automated System

K R Vaghela

Infra Control Systems (ICS) is running a Mastering the CSV Course for a small team of 10 people for US, Europe and Far East team since last two years. Now since webinar has started in a big way we decided to give the training to more no of people and hence the message in the social media for this kind of nearly One to one Type Training in a small group. Generally Industry experts join this training with some Beginner or experienced people wanting to know and study CSV and Data Integrity points to sharpen the Saw. Software Development Life Cycle goes hand in hand with Skill Development Life Cycle https://youtu.be/dJ1Cxo6YgME We try to cover Basic to advance things in this Eight day Course. Course will start from Monday 20th July 2020 at 6:00 hrs (IST GMT+5.30 hrs) in the morning and will run daily till it gets completed. Small adjustment in timing possible as per participants and also Weekly off can be planned as per the need. Please call On +919825047998, +918320551508 It is a Whatsapp plus IMO no. You can also write to infraics@gmail.com or connect to us through linked in.

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Good practice guidance on – CSV (21 CFR Part 11, Annex 11 EU GMP, GAMP 5) During COVID 19 Outbreak In ever changing business set-up, it is a challenge to develop an appropriate Validation Program that meets business, technology and compliance needs of the industry specifically when world is going through pandemic for COVID 19 virus outbreak. It takes a lot more than just a single technology to make computer systems comply with GxP/21 CFR Part 11 requirements. It involves, good quality processes and controls to have the systems comply with regulations and hold them in a validated state. EIC is organizing a webinar that focus on some of the challenges faced by industry in conceptualizing and implementing a validation program. This webinar explores with the audience the challenges in general and provides an advanced approach to Computer System Validation and compliance to 21 CFR Part 11. • Overview on CSV and 21 CFR Part 11 • Ensuring compliance with new normal • Risk Management and GAMP5 Risk Based approach • Keeping the computer system in validated state – Change Management • General challenges in building an effective validation program • Business returns for validation program • Managing Validation Projects during pandemic. • Q&A Session Who should Attend? This CSV webinar will benefit all who use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications. • IT Managers, • Project Managers, • Compliance Managers, • Regulatory Managers, • QA, • Drug Safety.

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Agaram QC Software for laboratory . MHRA also using one of them. • The Qualis suite of products comprising of LIMS, ELN, QMS and SDMS are architected in such a fashion it is available both as individual modules and also as a whole some integrated solution. In cases where a prospect has already made investments in certain software and is looking at additional functionality then their existing investments are well protected by going in for the appropriate module of Qualis and integrating them with the existing software. • Since n-tier architecture has been followed in designing Qualis suite of products, it has no rigidity on what the data base or O.S. should be. This means perse Qualis does not require additional investments in terms of environment related spend. • The product team at Agaram has extensive experience in this industry. Leveraging on this rich experience, the functionality has been coined. Currently, the product is in its 4th generation release, as a result of which it is extremely stable and scalable. • Agaram Technologies focuses exclusively in this space. As a result, it has laid out a clear vision for its Qualis suite of products. This is best illustrated in the fact that the next generation release has already been planned and is expected to be released in 2016.

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