Computer System Validation (CSV) & Data Integrity Challenges
- Real Time Online Delivery – Live Training Sessions
- Virtual Attendance for 4 Days Training
- Guided Learning Hours – 16 (4 Hrs x 4 Days)
- Case Studies, Practical Exercises, Q & A,
- Pre-Course Access: Intro Session Coupon, Pre-Event Questionnaire, Presentation Slide Deck
- 7+ Delegates Registration Group Discount
Course Overview
This 4 Day Online Course will give insights about FDA/EMA/MRHA regulations for pharmaceuticals, medical devices, biologicals, tobacco and tobacco-related products (e-cigarettes, e-liquids/vaping, cigars) that pertain to computer systems used to create/collect, analyze, manage, report and transfer data (structured) and documents (unstructured) that support regulatory compliance. Learn about FDA’s efforts with EMA and MRHA to move to a more consistent framework & procedures for evaluating computer systems, based on risk, and ensuring data/document integrity is maintained throughout their life cycle. The Mutual Recognition Agreement (MRA) between FDA and EMA will be discussed.
Review key components and deliverables of the Computer System Validation (CSV), based on the System Development Life Cycle (SDLC) Methodology. You will also learn about a validation strategy for mobile applications & systems that are cloud-based and 21 CFR Part 11, FDA’s guidance for electronic records and signatures, and the importance of data integrity to compliance activities. Examples of FDA actions and citations will be provided and best practices to meet compliance requirements and ensure a company is inspection ready.
As regulated products are often subject to counterfeit activity, you will learn about the efforts by US agencies, including FDA and Customs and Border Protection, to improve global supply chain security. Understand how the Customs and Trade Partnership Against Terrorism (C-TPAT), a voluntary program, provides a framework based on minimum security requirements that provide great benefit to member companies in terms of the speed and ease of moving products through the global supply chain.
Importance of performing a vendor audit for suppliers of computer systems, components and services will be discussed. In addition, you will learn about the challenges and best practices associated with compliance for software used with medical devices and Software as Medical Device (SaaS) products.
Trainer’s Profile
Our Expert Trainer is a Consultant & Training Specialist with 40+ years of experience in the pharmaceutical, medical device, biological, tobacco-related (e-cigarettes, e-liquids, cigars) and other FDA-regulated industries.
Our Expert worked directly and on consulting basis for many of the large regulated companies in the USA & Europe, developing and executing compliance strategies & programs for Computer System Validation (CSV) and Data Integrity.
Our Expert participated in the FDA/Industry partnership that resulted in issuing 21 CFR Part 11, FDA’s guidance for electronic records/signature.
Our Expert continues to speak and provide training worldwide about FDA and global agency trends in compliance, inspection and enforcement.
Key Takeaways
- Discuss how to meet current FDA regulations, including cGxPs and 21 CFR Part 11 for electronic records and signatures
- Understand how the Medicine and Healthcare Regulatory Agency (MRHA) in the UK plays a role in determining regulatory compliance within the EU
- Become proficient in how to validate a computer system that houses regulated data and documentation through a deep dive into the Computer System Validation (CSV) approach, which is based on the System Development Life Cycle (SDLC) methodology
- Create and maintain data and documents with integrity through their entire life cycle; data integrity issues have been a very strong focus of recent FDA inspections and audits
- Evaluate how to fit the CSV process and maintenance of data/document integrity into the Quality Management System to achieve results that will benefit the company’s bottom line and reputation
- Focus on how FDA expects industry to develop a risk-based approach to validation of a FDA- regulated computer system, along with considering the size, complexity, business criticality and GAMP 5 category of the system
- Learn about industry deficiencies and best practices to better align CSV and data/document integrity activities with key areas of focus
Who Should Attend
- Information Technology (IT) Analysts
- IT Developers & Support Staff
- QC/QA Managers & Analysts
- Clinical Data Managers & Scientists
- Compliance Managers & Auditors
- Lab Managers & Analysts
- Computer Systems Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Consultants in Life Sciences & Tobacco Industries
- Computer System Vendors & Service Providers (Implementation, Hosting, Configuration, Customization)
- Software Vendors providing Medical Device Software & Software as a Medical Device(SaaMD)
- Professional from tobacco-related product (e-cigarettes, e-liquids/vaping, cigars) industries
For participation details contact
Samuel Isaac
+1 786 633 1223(Canada)
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