Computer System Validation Pharma Compliance Management

08th - 09th February 2018 Mumbai - India

Course Description

Pharmaceutical Training Workshop
 
COMPUTER SYSTEM VALIDATION - CSV
Best Practices in Compliance Management
 
08th-09th February 2018 - Mumbai

Introduction:
A Course designed to completely engage you in Computer system Validation for the present Needs. This Course delivers Hands on experience knowledge on how CSV is treated and looked at in the present times. You will be ready for how to select the right validations and right controls (Technical and Procedural) Know how on handling PLC's.
 
Challenges:
  • Data Integrity with Documentation
  • Identifying right and appropriate Procedural and Technical controls
  • How Agile methodology works for Cat 5 development

Learning Objectives:

  • Role of FDA
  • CSV Points and why Validate
  • GAMP
  • Relation between 21 CFR Part 11, Annex 11 and 211
  • Risk Assessments
  • Data Integrity
  • CSV Deliverables (Technical and Procedural controls)
  • How to have an SOP and benefits and following the SOP's
Compliance Challenges:
The confusion due to what are often contrary interpretations of CSV requirements, the focus on generating extensive CSV packages, and fear of not meeting regulatory expectations turn many CSV projects into major endeavors that lose sight of the contribution to quality and compliance. A harmonized and consistent risk-based CSV is an effective way to optimize the investment allocated to corporate compliance programs.
 
Target Audience:
A must attend the seminar for professionals in Pharmaceuticals, QC Laboratories, APIs, Finished Products, Contract Laboratories, CROs, Medical Device & Biotech companies, and Suppliers of Computer Systems. DEPARTMENTS: Quality Control & Quality Assurance, Research and Development, Laboratory and Regulatory Compliance, IT/IS & Software Departments, Production & Manufacturing, Documentation, Training Departments PROFESSIONALS: Managers and Supervisors, Senior Managers and Team Leaders, General Managers, Analytical Chemists, Validation Specialists, Laboratory Managers and Supervisors, Regulatory Affairs Managers, Documentation Specialists & Analysts, Consultants, and Systems Administrators

Training Agenda

Computer System Validation (CSV) - Best Practices in Compliance Management

Day - One

Introduction and Agenda

Data Integrity

Validation Planning / Reporting/ System Release

Vendor Management

Requirements Specifications

Risk Assessments

Operation and Validation Maintenance

Q&A Close Out Discussion
 
Day - Two
 
Recap

Data Integrity

PLC Regulatory Interest, Impediments

Technical Vs Procedural predicate rules

Agile Validation for Cat 5

Q&A Close out Discussion
 
For Registrations contact us on: 022-62210100 or email us on: raj@marcepinc.com - techsupport@marcepinc.com

Course Director

Course Director: Venkata Ramana G. Multi years of rich experience in Life Sciences IT Compliance/CSV for FDA (GxP, 21 CFR Part 11), PIC/S, EUDRALEX, ICH and other regulations Internal Auditor, Agile Project Management, VB, Java, ISO 27001, HP AIS - Application Lifecycle Management v11. Life sciences, Healthcare, Training, etc. Apotex, Sun Pharma, Ranbaxy, Novartis, Ness, ADP, GE Healthcare (Satyam), Sr. Consultant in USA Computerized System Validation with IT Quality Internal / external Audits Program / Project / Delivery Management Compliance Management Quality Management Systems Life Sciences IT Compliance (FDA (21 CFR Part 11), IMDA, PICS, EUDRALEX) Building and Handling Validation/Quality CoE Global delivery with Complex Migrations Consent Decree Remediation & Replies to 483 with respect to IT compliance Gap Assessments for Consent Decree / 483 / Import Alert Remediation's Spreadsheets Validations Large-scale data center qualifications Management of SOP, policies. Trained more than 500 + Associates across
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