Holding Vendors Accountable through Robust Contracts & SLAs

Many companies go through the motions of putting the contract and SLA in place, but rarely have I seen the key team members who will validate the system take much interest in the gory details. This leaves everything to Purchasing and Legal, who are busy checking the language is standard and are not qualified to fully understand what needs to be included. They have very little investment in the outcome, especially as the validation team will be the front line of defense during an FDA inspection. When it comes down to an FDA audit, this is where often the wheels come off the bus.

To execute a contract and SLA that will truly benefit the performers in FDA-regulated industries, a number of key areas must be the focus of deeper and broader attention. The type of products and/or services will each have unique characteristics that must be accounted for in the negotiations. It is not just about cost, or whether the vendor is qualified. In the end, can you hold the vendor accountable? Often, this is a point sorely missed during the process.

Why Should You Attend:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation and tobacco. Functions that are applicable include production, quality, research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and trial management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any computer system governed by FDA regulations.

Areas Covered in the Webinar:

• Vendor Contracts
• Vendor Service Level Agreements (SLAs)
• Cybersecurity
• SOC 2 Certification
• Disaster Recovery and Business Continuity
• Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• Agile and Waterfall System Development Lifecycle (SDLC) Methodologies
• Automated Testing
• Commercial-Off-the-Shelf (COTS) Solutions
• Cloud Computing
• Software-as-a-Service (SaaS) Solutions
• Vendor Audit
• IT Change Control
• IT Incident Reporting, Investigation and Remediation
• GxP Data and Computer Systems Regulated by FDA
• Computer System Validation (CSV)
• The System Development Life Cycle (SDLC) Methodology
• Risk Assessment
• GAMP®5, 2nd Edition and Software Categorization
• Validation Strategy and Planning
• Functional Requirements Specification (FRS)
• Design/Configuration Specifications
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ) (User Acceptance Testing (UAT))
• Maintenance and Operational Support of FDA-Regulated Computer Systems
• Policies and Procedures to Support CSV
• Training Supporting CSV Activities
• Q&A

Who Will Benefit:

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.
Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Description:

In this webinar, the attendee will learn about the many best practices that will lead to a better and sounder contract and SLA. It does not require a lot of effort, but must be done with diligence.

It is time to embark on the AI/ML revolution and continue to deliver quality products with compliance to meet the needs of the consumers by putting newer, more innovative, safer, and more effective products in their hands, all of which are key focus areas for FDA.

Computer systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product, or a raw material or packaging component used in conjunction with the product during the manufacturing, testing or tracking processes). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.

It is important to be able to identify computer systems used when performing FDA-regulated activities. When a vendor is involved, whether in terms of provisioning hardware and/or software, implementing the system or maintaining it, this must be done in compliance with FDA requirements. A solid computer system validation strategy, along with an understanding of industry best practices, will lead your company to ensure that vendors are held accountable for delivery of systems and services that will support your efforts to validate computer systems and maintain them in a validated state.

We will cover Computer Off-the-Shelf (COTS) software applications, configurable systems and custom systems. We will also discuss Software-as-a-Service (SaaS) and similar cloud-based solutions provided by vendors.

Overall, we’ll discuss the industry best practices and note the pitfalls to avoid when negotiating a contract and SLA for systems regulated by FDA.

Keywords Related to this Training:

Vendor Contracts, Service Level Agreements (SLAs), Electronic Records, Electronic Signatures, Audit Trail, Agile Software Development Methodology, Waterfall Software Development Methodology, Computer Off-the-Shelf Software (COTS), Cloud Computing, Software-as-a-Service (SaaS), GxP Systems, GMP, GLP, GCP, Risk Assessment and Mitigation, GAMP®5, 2nd Edition, Good Documentation Practices, Quality Assurance, Data Integrity, System and Data Governance, FDA Warning Letter, FDA Consent Decree, Validation Planning and Execution, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) (User Acceptance Testing (UAT)), FDA Regulations, FDA Oversight, Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, 21 CFR Part 11 (electronic records/ electronic signatures)

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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