GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course (Recorded)

Computer system validation has been regulated by FDA for more than 40 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by the FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.

Why Should You Attend

This Seminar 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, regulatory affairs and submissions, adverse events management, and post-marketing surveillance.

The program will provide you with a current snapshot of the state of the industry and the FDA as both forge ahead in the face of ever-changing technology. The course provides insight into the ways in which Pharma 4.0™ will serve as an enabler for next generation medicinal products and new business cases for established products. The organizational, cultural, and technical processes and resources are key to the success of this endeavor.

The attendee will learn about Pharma 4.0 and the 4.0 Operating Model. We will discuss how Pharma 4.0 is governed by health regulations and some of the industry best practices that can help improve efficiency and effectiveness.

Pharma 4.0 can expand the connections between companies, FDA, and other stakeholders. During the course, we will review specific business cases for using Pharma 4.0 to determine the return on investment of Pharma 4.0.

We will discuss organizational and cultural practices that are essential to Pharma 4.0 success. We will cover the Pharma 4.0 Maturity Model and how this can provide a competitive advantage to a company.

Clearly, Pharma 4.0™ is not a must, but a competitive advantage. Missing Pharma 4.0™ might be a business risk. When moving from blockbusters to niche products and personalized medicines, Pharma 4.0™ offers new ways to look at business cases.

You’ll learn about the various stages of maturity for Pharma 4.0, moving toward a breakdown of silos in organizations and greater connectivity across the enterprise.