computer system validation

COMPUTER SYSTEM VALIDATION CERTIFICATION

 

About Course

To ensure that a computer-based system will produce data or information which meets a set of pre-defined requirements Computer System Validation (CSV) is important. Pharmaceutical and Medical Device manufacturing industries are highly regulated environments that directly impact public health & safety, hence the CSV process is imperative here. With the use of CSV the industry can maximize the effectiveness and enhance quality of their computer systems.

Our Computer system Validation training is specifically designed for professionals to understand the principles and regulations behind effective validation and qualification of a Computer based system. The course will benefit to everyone involved in Regulatory Audits and Computer System validations (CSV) both at domestic or international scale.

 

Course Scope

•To Study the Basic Fundamentals of Pharmaceutical Computer System Validation (CSV)

•To Understand the importance and underlying principles of CSV

•To Create a thorough understanding & Implementation of :

oValidation & its application to Computer Systems

oCFR part 11 compliance

oGAMP 5 Risk based approach

oMajor life cycles of computer systems

oSoftware categorization

oGood Documentation practices

Learning Outcome

•Understand and Implement Computer System Validation concepts

•Able to use GAMP5 Risk based approach

•Implement CFR Part 11 and Annexure 11 for CSV

•Preparation of audits involving Computer Systems

•Become a CSV Professional and get a Career growth

Course Structure

•Module 1: INTRODUCTION TO COMPUTER SYSTEM VALIDATION

•Module 2: GAMP 5

•Module 3: DATA COLLECTION & VALIDATION EXECUTION ACTIVITY

•Module 4: RISK ASSESSMENT

•Module 5: 21 CFR PART 11

•Module 6: DATA INTEGRITY & ALCOA++

•Module 7: REGULATORY REQUIREMENT OVER CSV

Course methodology

•Online Access to Lectures pertaining to above mentioned course topics

•This is a Distance learning Program – where students participate by filling necessary forms and paying the fees.

•Introduction Kit is delivered to participants of the program – this kit will contain study material and all necessary information about the program with important dates.

Course Specifics

•Course Name: Certificate Course in Computer System Validation

•Course Duration: 3 months

•Course Fees: Rs.

Eligibility

Graduates in any stream of science are eligible to apply.

Who Should Apply

•Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, and all levels of management who need a fundamental understanding of computerized system compliance and regulations.

•This course is ideal for anyone in the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical and Skin/Cosmetic industries who is tasked with validation activities

•Computer system vendors or consultants, engineering contractors, and validation service companies.

Apply Online

Students can download the admission form in PDF format, print and fill the same, clearly mentioning Mobile No & Course Interested. The Filled form should be sent to us along with fees payment details on our email address: info@regulatoryinstitute.com

www.regulatoryinstitute.com/csv-training.html

 

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