Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance

May 07	01:00 PM ET / 12:00 PM CT / 11:00 AM MT / 10:00 AM PT
	Duration: 90 minutes	Speaker: Carolyn Troiano

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ABOUT THE EVENT

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 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 You Should Attend

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.

Areas Covered

Learn about the “12 Theses” of Pharma 4.0
Pharma 4.0™ extends/describes the Industry 4.0 Operating Model for medicinal products
In deference to common Industry 4.0 approaches, Pharma 4.0™ embeds health regulations best practices
Pharma 4.0™ breaks silos in organizations by building bridges between industry, regulators and healthcare and all other stakeholders
For the next Generation Medicinal Products, Pharma 4.0™ is THE enabler and business case
For the established products, Pharma 4.0™ offers new business cases
Investment calculations for Pharma 4.0™ require innovative approaches for business case calculations.
Prerequisite for Pharma 4.0™ is an established PQS and controlled processes & products.
Pharma 4.0™ is not an IT Project.
The Pharma 4.0™ Operating Model incorporates next to IT also the organizational, cultural, processes & resources aspects.
The Pharma 4.0™ Maturity Model allows aligning the organizations operating model for innovative and established industries, suppliers and contractors to an appropriate desired state.
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.
Q&A

Who Should Attend

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

Pharmaceutical
Medical Device
Biologicals
Tobacco (based on the Tobacco Control Act of 2009)
E-Liquid/Vapor (based on the “Deeming” Act of 2016)
E-Cigarette (based on the “Deeming” Act of 2016)
Cigar (based on the “Deeming” Act of 2016)
Third-Party companies that support those in the above industries

Personnel in the following roles will benefit:

Legal
Marketing
Information Technology Analysts
QC/QA Managers
QC/QA Analysts
Clinical Data Managers
Clinical Data Scientists
Analytical Chemists
Compliance Managers
Laboratory Managers
Automation Analysts
Manufacturing Managers
Manufacturing Supervisors
Supply Chain Specialists
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
Auditors engaged in the internal inspection

Speaker(s)

Carolyn Troiano

Carolyn Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn participated in the FDA/Industry team that drafted 21 CFR Part 11, the FDA Guidance for Electronic Records and Electronic Signatures (ER/ES). She is active in seeking ways to streamline the validation process and do what she terms “Common Sense Validation,” removing tasks that do not add value, but carefully taking a risk-based approach and using critical thinking to drive plans and activities.

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