Dates: May 10th - 11th, 2018

Location: BANGALORE, India

Presenter: Kalpeshkumar Vaghela

Download Your Brochure & Registration Form

DESCRIPTION

This interactive 2-day Seminar on Computer Systems Validation, Part 11 Compliance for Software Validation and SaaS/Cloud, explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.

Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.

The instructor will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

WHY YOU SHOULD ATTEND

Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions.

Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Participants learn how to decrease software implementation times and lower costs using a step-by-step risk-based approach to computer system validation. Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.  .

COURSE OBJECTIVE

  • Understand what is expected in Part 11 and Annex 11 inspections
  • Avoid 483 and Warning Letters
  • Learn how to buy COTS software and qualify vendors.
  • Implement a computer system using risk-based validation
  • Gain maximum productivity and reduce cost
  • Requirements for local, SaaS, and cloud hosting
  • How to select resources and manage validation projects
  • "Right size" change control methods that allows quick and safe system evolution
  • Minimize the validation documentation
  • Reduce costs without increasing regulatory or business risk
  • Avoid Data Integrity Issues
  • Write test cases that trace to elements of risk management
  • Protect intellectual property and keep electronic records safe

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, IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors and Suppliers of Computer Systems. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

DEPARTMENTS

Quality Control & Quality Assurance
IT/IS & Software Departments
Research and Development
Laboratory
Regulatory Compliance
Validation
Production & Manufacturing
Documentation
Training Departments

PROFESSIONALS

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

PRESENTER

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.

Kalpesh R Vaghela Compliance Trainings

AGENDA

DAY 1

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM (Welcome and Introduction)

Regulatory Requirements and Expectations
- US FDA and other Regulatory Guidance
- How the regulations help your company to be successful
- Which data and systems are subject to Part 11

21 CFR Part 11
- What Part 11 means to you, not just what it says in the regulations
- Annex 11 Latest Updates
- Avoid 483's and Warning Letters
- SOPs, software product features, and validation documentation
- How SaaS/cloud computing changes qualification and validation
- Electronic signatures, digital pens, and biometric signatures
- Using validation documents

Data Integrity
- 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
- ALCOA
- Maintenance Qualification
- Data integrity Inspections – How FDA & other Regulatory Authorities Inspect

Computer Systems Validation
- Understanding CSV & Validation Team
- Risk-Based System Validation per GAMP5
- Laboratory Instrument Validation
- GxP Assessment
- Patch Management
- Validation & Revalidation
- Qualification vs Validation

Q&A Session
Networking and Close: 5.00 PM – 5.30 PM

DAY 2

.
Session Start Time: 9:00 AM

Commercial Off-the-Shelf CSV
- Documents the FDA expects to audit
- How to use the risk-based validation approach to lower costs
- How to link requirements, specifications, risk management, and testing
- SOPs required for the IT infrastructure
- How to Write Requirements
- How to Write Specifications
- How to Write Protocols

Hazard Analysis / Risk Assessment - Exercise
- Understanding Risk Assessment
- Regulatory Expectations
- Step-by-step instructions for performing and documenting a risk assessment
- How to use the results to reduce validation documentation
- Regulatory Expectations

Software Testing
- Reduce testing by writing test cases
- How to write efficient test cases

System Change Control
- How to manage a validated system with minimal documentation

Purchasing COTS Software
- How to purchase COTS software and evaluate software vendors

Cost Reduction Without Increasing Regulatory or Business Risk
- How to save money
- How to increase quality
- How to increase compliance with less documentation

Final Q&A Session
Certification, Networking and Close: 5.30 PM – 6 PM

PRICING & REGISTRATION

Limited Seats Available with Discounts

HOW TO REGISTER, AND TERMS & CONDITIONS

VENUE DETAILS

  • Address
    Hotel Sarovar Portico, Hosur Main Road, Bangalore
Bangalore, India

Venue:
Hotel Sarovar Portico
Opp. Madiwala Police Station, Hosur Main Road,
Koramangala, Bangalore, Karnataka 560068

PARTNER WITH COMPLIANCE TRAININGS

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