Mastering Compliance
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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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process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation. The objective of regulated computer systems includes systems
used to manage data or support descion making subject to review by regulated authorities whether they are being
submitted because its impact on quality or on business. Investments in computer systems supporting the quality controls
to ensure that the process is followed correctly, reducing human error and the need to conduct manual checks,
Standardization of practices to build consistent ways of working, Speed-up of process cycle times by reducing wait times
and by improved scheduling...etc.Computer systems shouldn't be enforced only for restrictive compliance; operational
advantages must always be exploredas well. “U.S. Code of Federal Regulation 21 CFR Part 600, 606, and 610” and “EU
Directive 2003/94/EEC” are the prominent regulations reqested CSV, while “Volume 4 Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use - Annex 11: Computerised Systems” considered the main guidlines for
CSV in biopharmaceutical industries in European Union. This paper aims to provide simplifed guidance on the basic
requireents for computer system validation (CSV) based on the latest regulatory developments and industry trends. In
conclusion, CSV has the great impact on the processes improvement. Also the critical parameters of computer systems
validation for biopharmaceutical indsutries are highlighted.
#AHMED_HASHAM
https://medwinpublishers.com/OAJPR/computerized-systems-validation-csv-in-biopharmaceutical-industries.pdf
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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.
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• 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,
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measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation. The objective of regulated computer systems includes systems
used to manage data or support descion making subject to review by regulated authorities whether they are being
submitted because its impact on quality or on business. Investments in computer systems supporting the quality controls
to ensure that the process is followed correctly, reducing human error and the need to conduct manual checks,
Standardization of practices to build consistent ways of working, Speed-up of process cycle times by reducing wait times
and by improved scheduling...etc.Computer systems shouldn't be enforced only for restrictive compliance; operational
advantages must always be exploredas well. “U.S. Code of Federal Regulation 21 CFR Part 600, 606, and 610” and “EU
Directive 2003/94/EEC” are the prominent regulations reqested CSV, while “Volume 4 Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use - Annex 11: Computerised Systems” considered the main guidlines for
CSV in biopharmaceutical industries in European Union. This paper aims to provide simplifed guidance on the basic
requireents for computer system validation (CSV) based on the latest regulatory developments and industry trends. In
conclusion, CSV has the great impact on the processes improvement. Also the critical parameters of computer systems
validation for biopharmaceutical indsutries are highlighted.
#AHMED_HASHAM
https://medwinpublishers.com/OAJPR/computerized-systems-validation-csv-in-biopharmaceutical-industries.pdf
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We Conduct Full CSV Course plus Individual Seminar, Webinar for person who has very specific interest.
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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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Specialized training 01082016
The document discusses the importance of training staff on data integrity, 21 CFR part 11 compliance, and computer system validation. It notes that properly trained staff can help design better systems and review/approval mechanisms.
It then provides details on specialized training courses it offers related to data integrity, 21 CFR part 11 compliance, GAMP5, risk assessment, and software validation.
Finally, it discusses how lack of compliance can negatively impact pharmaceutical companies through loss of market cap, production losses, and increased costs of remediation. It emphasizes that selecting a qualified software validation consultant is important to safeguard data, processes, and quality.
Kvs what we can do for you 01082016
1) KVS Technologies was created to help companies achieve compliance through quality automation and training. They teach the basics of compliance so that employees are motivated to do quality work.
2) KVS has helped many companies in India and abroad with software validation, data integrity, and compliance training. Their services can help reduce corrective actions, change controls, batch recalls, and ensure patient safety.
3) KVS is regarded as the top software validation company in India, having worked with 80% of the major Indian pharmaceutical companies. They offer a wide range of validation and compliance services and training.
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Ics company overview marketing
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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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We can bring worlds top class services at your Company.
) We can help you in Oracle and Other SaaS Services. Clinical Research programming , Training Etc.
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World Says Switch off
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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.
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Environment friendly – green energy. No UV or IR radiation, No mercury or lead.
Low voltage – shock proof.
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Mastering Compliance
- 1. INFRAICS@YAHOO.COM INFRAICS@GMAIL.COM TWITTER HANDLE +919825047998 +918320551508 HTTPS://WWW.LINKEDIN .COM/IN/CSVREMDIATIO NTRAININGPARTNER KEY TOPICS 1. INTRODUCTION A. What is computerized system? B. What is CSV and its history? C. Why CSV and the big picture? I. GMP II. GCP III.GLP 2. DATA INTEGRITY REGULATIONS & GUIDELINES A. MHRA B. FDA AND ITS ROLE C. ICH D. PIC/S E. GAMP (ISPE) (Computerized System) 3. GOVERNANCE AND VALIDATION A. Validation Strategy B. Validation Framework C. Validate and Quality PLC Machines D. Good Documentation Practices & Management COMPUTER SYSTEM VALIDATION TRAINING BY KAPESHKUMAR VAGHELA KEY TOPICS 4. GAMP 5 GUIDELINES A. Introduction to GAMP5 Guidelines & risk-based approach B. GAMP4 vs GAMP5 C. GAMP5 Drivers and Deliverables for CSV D. Computer Validation as per GAMP5 E. GXP Assessment 5. SYSTEM LIFECYCLE A. Software & Hardware Categories 6. CHANGE MANAGEMENT A. Overview of Objectives and types of changes 7. PATCH MANAGEMENT 8. INCIDENT MANAGEMENT & PROCESS 9. REGULATORY REQUIREMENT UNDER 21 CFR PART 11 AND ANNEX 11 FOR CSV A. Main points B. Types of Systems C. Records & Signatures 10. RISK MANAGEMENT A. Risk Assessment using Risk Based Approach for CSV B.Risk & Causes 11. USER REQUIREMENT SEPCIFICATION (URS), FUNCTIONAL SPECIFICATION (FS), CONFIGURATION SPECIFICATION (CS) 12. DATA MIGRATION 13. OPERATION ASPECTS A. Backup and Restore B. Disaster Control & Business Continuity Planning & Testing C. Periodic Review D. Data Archive & Retrieval 14. TRACEABILITY 15. DOCUMENT MANAGEMENT
- 2. COMPUTER SYSTEM VALIDATION TRAINING BY KAPESHKUMAR VAGHELA INFRAICS@YAHOO.COM INFRAICS@GMAIL.COM HTTPS://WWW.YOUTUB E.COM/C/KALPESHVAG HELACSVTRAINERANDC ONSULTANT +919825047998 +918320551508 HTTPS://WWW.LINKEDIN .COM/IN/CSVREMDIATIO NTRAININGPARTNER 16. SECURITY A. Data Security B. Data Integrity in CSV C. Data Migration D. ALCOA+ E. Recent 483s issued on CSV and Data Integrity F. Cloud Validation 17. REMEDIATION 18. INSPECTION READINESS 19. CONCLUSION AND Q&A 20. CASE STUDY BASED ON WORK EXERCISE