GAMP5, CSV AND CLOUD VALIDATION TRAINING BY KALPESHKUMAR VAGHELA

PROGRAMME DETAILS

Dates: 25 Apr 2021 (Sunday) to 30 APR 2021 (Friday)

Timings: 08:00 PM to 10.00 PM IST
Total Duration:  12 Hours (Daily 2 Hours for 6 Days) 
Mode of Training: Google Meet

 

PROGRAMME FEES:
Rs 19,000 + GST (18%),
USD 425 for foreigners

Early Bird Offer: Rs 18,000 + GST (18%)

Early Bird Offer ends on 15-APR-2021

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Eligibility Criteria

 Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:

  • Applicants are recommended to have one of the following life Science degrees: B. Pharmacy, M.Pharmacy, Bachelor’s, Master’s in Life-Sciences(Microbiology, Biochemistry, Biotechnology or related fields), B.Tech (Biotechnology/Bioinformatics / Pharmaceutical Science) / M.Tech (Biotechnology)/B.Sc./M.Sc, B.Tech (Computer Science/ Electronics/ IT or related field, MCA or any diploma holder and all professionals working with IT, Pharmaceutical Organizations & CROs. 

  • Working professionals of any of the following industry types Such as IT, Drugs manufacturing, Medical Device, OEM, Validation, CRO, QA, QC, Food, Clinical Research, Cosmetic Manufacturing, Biotechnology, Auditing, Consulting or any related industry are highly encouraged to apply for the programme.

 

 

 

 

 

 

 

 
 
 
 
 
 
 
 
 
 
 

WHAT IS COMPUTER SYSTEM VALIDATION

Computer Systems Validation (CSV) is a process used to ensure that a computer-based systems will produce information or data that meet a set of defined requirements. The process is used within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing. Computer validation is more than a compliance requirement. It not only reduces regulatory risk, but it also increases understanding of system during project implementation and enforces a structured, well-defined execution of the project. Pharmaceutical computer system validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality, with the potential to save cost and time. Subject matter expert (SME) of CSV will have a major role in achieving these benefits. This course will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale.  Additionally, this course will be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, Quality Control and other job functions which are impacted by CSV efforts.  This course is particularly useful to those who interface with vendors, FDA and other regulatory agencies.

This course will provide extensive training in Computer system validation.  The process is used within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing. It’s crucial that any process within these manufacturing industries reliably behaves in a consistent way.

Pharmaceutical manufacturing and medical device manufacturing industries are increasingly relying on computer systems to operate a range of manufacturing processes, so it’s more important than ever that these systems can be relied upon to follow a predetermined specification.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Why CSV?

Regulated industries, such as pharmaceutical manufacturing, have to adopt many compliance procedures to make sure their final product is safe for distribution or sale. CSV is one of those compliance requirements and is part of the Quality Management System within pharmaceutical manufacturing.

So what exactly does CSV deliver to these industries?

  • Accuracy – When test outcomes are routinely checked against predetermined expected results, the      accuracy of computer systems within the manufacturing process can be relied upon
  • Security – CSV processes make clear when entries to the system have been altered
  • Reliability – The process ensures that system outputs can be relied upon throughout the lifecycle
  • Consistency – it also ensures that the system output is consistent across its lifecycle
  • Optimisation – following the process also means that computer systems can be more easily optimized. Optimisation is a key feature of an effective and efficient manufacturing site.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Key Topics

TOPICS COVERED:

  • GAMP 5
  • How to Manage Change and Configuration in Effective way
  • Calibration, Qualification and Validation
  • CFR part11 compliance
  • Annex 11
  • ALCOA+
  • GDP- Good Documentation Practices and ERES Practices.
  • Mastering   Computer   Systems   Validation   Deliverables.
  • 483 –warning letter Response & Remediation
  • Risk Assessment and Management
  • Brief Details on Cloud   Validation   –   IaaS, SaaS, PaaS,   Types   of   Cloud, Importance of SLA
  • Periodic   Review   Protocol   and   Report (Reduce   your revalidation work scientifically)
  • Good Check list to control Data Integrity
  • Eight habits of highly compliant Organizations
  • cGMP as per 21 CFR 211 Key points
  • GxP Work Flow
  • Data Life Cycle
  • Software Development Life Cycle 
  • Vendor and Equipment Qualifications.
  • How to host Data Integrity Audit.
  • Three Process Flow Can help you control CSV in best possible way.
  • Black Box- White Box Validation
  • Legacy – Hybrid Systems
  • Open – Close Systems
  • Open Close – Culture
  • Software – Hardware Category as per GAMP5
  • Risk based work based on Novelty- Complexity and Critical Thinking
  • Static – Dynamic Data
  • Raw- Meta Data
  • Active – Passive Data
  • Analyses of One 483 – Warning letter
  • Good Remediation
  • Multiple Case studies
  • Role of FDA to 482-482-484-EUA
  • Type of inspection by FDACSV versus CSA
  • Data Integrity Check list
  • Cloud Validation
  • IaaS, PaaS and SaaS
 
 
 
 
 
 
 
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