• Home
  • Gratisol Labs - Pharmaceutical Computer System Validation Certification Course - Gratisol Labs

Gratisol Labs - Pharmaceutical Computer System Validation Certification Course - Gratisol Labs

Computer System Validation Training – Seminar on CSV focusing on cost reduction and how to avoid FDA form 483s & complying with 21 CFR Part 11

  • Duration 30 hours
  • Students Enrolled 27
  • Last Updated May 22nd, 2020
(0 rating)
₹30,000.00 ₹20,000.00
Gratisol Labs – Pharmaceutical Computer System Validation Certification Course

ADVANCED CERTIFICATION PROGRAM IN PHARMACEUTICAL 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 DO WE NEED COMPUTER SYSTEMS VALIDATION?

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.

 Following Course Content will be covered during the training:

  • Common terms and definitions of Computer Systems Validation
  • The elements of System Development Life Cycles (SDLC)
  • Good Automated Manufacturing Practices (GAMP).
  • Data integrity issues in the eyes of GxP regulators.
  • How computer systems are regulated in FDA environments
  • Ability to recognize the compliance, risk, and regulatory consequences of using computer systems
  • Achieving and Maintaining 21 CFR Part 11 Compliance
  • Training-on ERP Systems Validation.

Following Modules will be covered during the Basic Certification program with Live project test case scenarios:

  • Module 1: Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare industries
  • Module 2: Qualification and Validation
  • Module 3: Introduction to Computer System Validation
  • Module 4: Software Development Life Cycle (SDLC)
  • Module 5: Regulatory requirements for software validation-21 CFR Part 11 (A detailed analysis of USA and EU perspectives )
  • Module 7: Risk based approach to software quality and Validation
  • Module 8: GAMP 5 Guidelines & Software Categories
  • Module 9: Implementation in Life science verticals
  • Module 10: Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000
  • Module 11: GDP, GCP, GMP guidelines 

 Following Modules will be covered during the Advanced Certification program with Live project test scenarios:

  • Module 1: Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare industries
  • Module 2: Qualification and Validation
  • Module 3: Introduction to Computer System Validation
  • Module 4: Software Development Life Cycle (SDLC)
  • Module 5: Regulatory requirements for software validation-21 CFR Part 11 (A detailed analysis of USA and EU perspectives )
  • Module 6:  Software Quality Audit
  • Module 7: Risk based approach to software quality and Validation
  • Module 8: GAMP 5 Guidelines & Software Categories
  • Module 9:  GDP, GCP, GMP guidelines
  • Module 10: Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000
  • Module 11: FDA Inspections & Warning Letters (A case study based approach)
  • Module 12: Importance and Principle of Data Integrity
  • Module 13: Developing the Data Integrity Plan and Guidance document on Data Integrity

 ELIGIBILITY:

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 Drugs manufacturing, Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the programme.     

SELECTION PROCEDURE:

  • To Maintain High Academic Standard, Gratisol Labs Gives Due Importance To The Quality Of Students Enrolled. To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure:
  • Personal Interview 
  • Screening And Selection Of Students 

OUR TEAM OF EXPERIENCED CSV SPECIALISTS ALSO PROVIDES THE FOLLOWING UPON SUCCESSFUL COMPLETION OF TRAINING:

  • Resume Preparation 
  • Interview Preparation with real time questions and answers
  • Mock Interview Sessions
  • Communication Skills and Personality development Sessions
  • Placement Assistance

PLACEMENT ASSISTANCE:

The Institute has partnered with many Pharmaceutical & Healthcare organizations for providing placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and IT Companies like  TCS, Infosys, Wipro, Cognizant, HCL, Accenture, Dr. Reddy’s Laboratories, Aurobindo Pharma, Cipla, Wockhardt, Pfizer, Abbott, Medtronics, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy, Biocon etc.

FUTURE CAREER PROSPECTS OF COMPUTER SYSTEM VALIDATION:

Companies, particularly the Pharmaceutical industries must validate their information technologies (such as computer systems, software’s that run on them and infrastructure components) to ensure they meet the intended business needs. Computer System Validations involve activities primarily around generating requirements and specification documents, testing the systems against those specifications, documenting test results and writing final reports. There is definitely a bright career path if one is willing to learn about personnel process and technologies.

Computer System Validation field had enjoyed an explosive growth since the early 90’s.  IT professionals, software vendors and developers, research, development and manufacturing associates and scientists, healthcare and clinical professionals, quality management professionals and technical project managers are dedicated to this field and the need is steadily growing as technology evolves and regulations increase.  After completion of this course, professionals can work as computer system validation specialist, validation engineer, validation consultant/analyst, QA consultant, IT validation analyst.

CERTIFICATION:

Certificate will be provided for this Course on successful completion of Self Assessment Assignments & Live Projects. Certificate would be awarded at the end of the program by Gratisol Labs.

For more information, please contact Gratisol Labs at info@gratisol.com

Meet your instructors

Gratisol Labs

Gratisol Labs

Subject Matter Expert - Pharmacovigilance

  • Students: 27
  • Duration: 30 hours
  • Effort: 2–5 hours per week
  • Institution: Gratisol Labs LLC
  • Subject: Pharmaceutical Validation CSV
  • Quizzes: Yes
  • Language: English
  • Video Subtitle: English
  • Certificate: Yes
Curriculum is empty
Get connected with preferred campus
//
Pune
//
Bangalore
//
Hyderabad
Connect with us on Whats App