Holding Vendors Accountable through Robust Contracts and Service Level Agreements (SLA) for Products and Services Used in FDA-Regulated Operations

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

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 per 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 the 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's best practices and note the pitfalls to avoid when negotiating a contract and SLA for systems regulated by the FDA.

This webinar is intended for those working in FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation, and tobacco. Applicable functions 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.

• Vendor Contract Negotiations
• Vendor Service Level Agreement (SLA) Negotiations
• Vendor Audit
• Vendor Questionnaire
• Leveraging Vendor Documentation
• Vendor Management
• Contract Management
• SLA Management
• FDA GxPs
• Computer System Validation (CSV) Methodology
• Computer Software Assurance (CSA) Methodology
• System Development Life Cycle (SDLC) Framework
• Critical Thinking
• Risk Management
• GAMP®5, Second Edition (Good Automated Manufacturing Practice)
• Automated Testing
• Waterfall Methodology
• Agile Methodology
• Compliance Strategy
• Cloud-Based Vendors & Validation
• Software-as-a-Service (SaaS) Vendors & Validation
• Infrastructure-as-a-Service (IaaS)
• Platform-as-a-Service (PaaS)
• Cost vs. Compliance
• SOC 2 Certification for cybersecurity
• Policies and Procedures
• Training
• Industry Best Practices
• Q&A

In the IT world, contracts and Service Level Agreements (SLAs) are often very standard, cookie-cutter agreements, and what I have found in my decades of consulting related to GxP systems, they are not scrutinized appropriately. This will likely be a large capital investment or expense to the company, and it is clear that the experiences of many in the Life Science industries have proven less than acceptable.

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.