Limited Seats Available with Discounts
Computer System Validation (CSV), Data Integrity and 21 CFR Part 11 Compliance
Dates: April 19th - 20th, 2018
Location: MUMBAI, India
Presenter: Kalpeshkumar Vaghela
Download Your Brochure & Registration Form
This new 2-day Seminar on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance.
Majority of inspection reports such as 483’s and Warning Letters quote issues with 21 CFR Part 11 and data integrity as deviations from GxP regulations. Only way to control and avoid warning letters is by receiving effective Training. Our presenter’s extensive years of experience in the field of third party audit can help your team to better understand & could help reduce your vulnerability of getting 483’s and warning letters, by great amount.
You will get a full understanding of how to perform Risk Assessment as part of the step-by-step risk-based approach to computer system validation. This distinct approach will help minimize project time. You can ensure compliance with QA, FDA, and clients.
A central element of this course will be an explanation of the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international regulations covering ERES. The GAMP Guide provides timely and much needed direction on meeting current regulatory expectations for compliant ERES. You will learn how to use risk management to ensure compliance of regulated ERES.
Our instructor will use examples and real life case studies to better illustrate the application of the techniques for any validation project. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met. With effective implementation of learnings from this seminar, you can avoid warning letters, reduce costs, improve quality, increase compliance with less documentation.
The course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. .
- Role of FDA
- CSV Points
- Why Validation? Its Benefits
- GAMP 5
- 21 CFR Part 11 Compliance
- Annex 11
- Data Integrity
- Risk Assessment
- Recent Learnings & Avoiding Warning Letters
- CSV Deliverables
- SOPs and Best Practices
- CASE STUDIES ….and More
WHO MUST ATTEND
A must attend seminar for professionals in Pharmaceuticals, QC Laboratories, Manufacturers of drug substances (APIs), Finished Products, Contract Laboratories, CROs, Medical Device & Biotech companies, and Suppliers of Computer Systems.
- Quality Control & Quality Assurance
- Research and Development
- Regulatory Compliance
- IT/IS & Software Departments
- Production & Manufacturing
- Training Departments
- Managers and Supervisors
- Senior Managers and Team Leaders
- Directors, VP’s, CxO’s, General Managers
- Analytical Chemists
- Validation Specialists
- Laboratory Managers and Supervisors
- Regulatory Affairs Managers
- Documentation Specialists & Analysts
- Consultants and Systems Administrators
Mr. Kalpesh R. Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.
Over 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma Industry.
He has worked with and trained professionals in numerous major Indian companies. He has close to a decade of international experience of working with companies located in USA, Canada, South America, Norway, Africa, Middle East, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.
Mr. Vaghela has joined hands with Compliance Trainings as an Expert Trainer and Consultant with a common mission to share knowledge and empower the Indian Life Sciences Industry.
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM (Welcome and Introduction)
- Understanding Validation
- V Module
- GAMP 4 vs GAMP 5
- Validation Master Plan (VMP)
- Supplier Agreement and Vendor Agreement Report
- Understanding GAMP 5
21 CFR Part 11
- Important Observations
- Annex 11
- Legacy System, Open and Close System
- Electronic Records & Hybrid Systems
- Electronic Signatures, Digital & Biometric Signatures
- Black Box and White Box
- Learning from Recent Warning Letters related to Part 11
- 21 CFR Part 11 compliance of a computer system
- Understanding Data Integrity and Security
- Most frequent data integrity issues & their impact
- Knowing the occurrence of data integrity failures
- Data Backup, Restoration, Archival & Retrieval, Retention
- Maintenance Qualification
- Data integrity Inspections – How FDA & other Regulatory Authorities Inspect
- Computerized Systems for Data Integrity
Networking and Close: 5.30 PM – 6 PM
Session Start Time: 9:00 AM
Computer System Validation
- Understanding CSV & CSV as per GAMP 5: It’s Easy!! Really!!
- CSV Components and Deliverables
- User Requirement Specification (URS), Functional Specifications (FS) & Design Specification (DS)
- TRM, SR, IRA and FRA
- Risk Based Approach for CSV
- Understanding Risk Assessment
- Risk-Based Validation approach to lower costs
- Regulatory Expectations
- Examples and Good Practices
- Benefits of larger project
CSV - Step-by-Step
- Formation of Validation Team
- Writing Effective URS
- Deliverable SRS and GxP Assessment
- Qualification (IQ, OQ, PQ and DQ) and Traceability Matrix
- Effective Installation and Testing
- Risk Based Approach for CSV per GAMP Category
- Effective SOPs, Verification and Testing
- Validation & Revalidation
- Qualification vs Validation
- Avoiding Warning Letters and Reduce Cost
Final Q&A Session
Certification, Networking and Close: 6 PM – 6.30 PM
PRICING & REGISTRATION
To be announced soon