How to Buy COTS Software, Audit Vendors and Validate the Software

Tuesday, Mar 28, 2017 at 11:30AM - 2:30PM

Event Details

This presentation will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and evaluating software vendor(s). Presentation will highlight essential data and systems subject to Part 11 & Annex 11 (ERES - Electronic Records and Electronic Signatures) compliance while listing requirements for IT infrastructure, Laboratories, Manufacturing/ Operations, R&D, Regulatory and other GxP relevant areas of an FDA regulated manufacturer. By taking the course, Developing / Start-up companies will have an edge in avoiding costly mistakes due to misunderstanding and omissions, common for a company in its infancy. For the emerging / existing and companies experiencing 483's, Consent Decree, CAPA's, Remediation; meaningful insight will be provided to quickly and efficiently bring compliance to computerize/software systems.

Objectives Of The Presentation
  • Project Charter
  • Vendor Audits
  • Validation Master Plan
  • Requirements Documents
  • Risk Assessment / Management
  • IQ, OQ, PQ Validation Plan
  • Protocols / Procedures
  • GAMP 5 Standards
  • 21 CFR Part 11 & Annex 11 Regulations
  • Associated / Relevant documents
  • Avoidance of 483's / Warning Letters
Why Should you Attend
This webinar will provide the process steps to:
  • Buy Commercial Off-The-Shelf (COTS) software
  • Evaluate / Vetting / Audit of software vendors
  • Validate for 21 CFR Part 11 / Annex 11
Presentation will detail the SOPs, product features and developer validation & specifications documentation requirements for auditing software vendors. Attendees will learn how to efficiently validate COTS software and understand how to use change control for currently validated systems.

Areas Covered
  • How to buy COTS software
    • Product features to look for when purchasing COTS software
    • How to evaluate a software vendor
    • Which data and systems are subject to ERES
  • Learn the requirements for IT Infrastructure / CSV Compliance
  • Understand the current computer system industry standards for security, data transfer, end-to-end testing, data integrity, audit trails and electronic signatures
  • SOPs required per GAMP 5 standards and ERES regulations
  • Avoid 483 and Warning Letters
Who will Benefit
  • Computer system Users, SME's, Technical Owners and Business Owners
  • IT Developers, Business Admins, Implementation Specialists
  • IT department
  • QC, QA, QE
  • Managers and executives
  • Training Department
  • Regulatory Affairs
  • Production / Manufacturing and lab managers
  • Documentation department & Consultants.

For Registration


Note: Use Promo code PTY2D and get 10% off on registration (Valid till MARCH 31st 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont 94536

Starts March 28, 2017 at 11:30AM - 2:30PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896