New
SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Introduction to FDA 21 CFR Part 11 — Electronic Records and Electronic Signatures Course & Certification
Intermediate
Watch Preview
4.7
★★★★★
97% Recommended
3 hours
0 active users
2 points
Watch Preview
Your Study Basket
Introduction to FDA 21 CFR Part 11 — Electronic Records and Electronic Signatures
| Total | |
VAT is levied as per your country’s applicable rules and rates at checkout
Save more with a monthly or annual plan that includes this course
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
The Introduction to FDA 21 CFR Part 11 — Electronic Records and Electronic Signatures Course & Certification is designed to provide a clear understanding of regulatory requirements for managing electronic records and signatures in FDA-regulated environments. The course focuses on ensuring data integrity, security, and compliance in computerized systems used in clinical, pharmaceutical, and laboratory settings.
This course covers 21 CFR Part 11 requirements, electronic records management, electronic signatures, system validation, audit trails, data security controls, and regulatory expectations. It also emphasizes compliance strategies, documentation practices, and inspection readiness for digital systems. Upon successful completion, learners receive a certification demonstrating competency in FDA 21 CFR Part 11 compliance.
Who Should Enrol?
- Clinical Research Professionals
- Pharmaceutical and Biotechnology Professionals
- Quality Assurance and Validation Teams
- Regulatory Affairs Professionals
- Data Management and IT Professionals
- Laboratory and Manufacturing Personnel
- Life Science, Pharmacy, Chemistry, and Engineering Graduates
What you will learn
Understand the fundamentals of FDA 21 CFR Part 11, including its scope, purpose, and relationship with predicate rules for electronic records and signatures.
Learn key requirements such as electronic records, electronic signatures, audit trails, system controls, and differences between closed, open, and cloud-based systems.
Gain knowledge of compliance enablers including computer system validation, data integrity (ALCOA+), and practical implementation of Part 11 requirements in regulated environments.
Develop an understanding of FDA inspection expectations, enforcement approaches, and real-world application of compliant electronic systems in clinical and pharmaceutical operations.
Course Syllabus
- 21 CFR Part 11 Explained
- Electronic Records Under Part 11
- What Are the Predicate Rules?
- Relationship to the Predicate Rules
- Predicate Rules and Batch Records
- Electronic Signatures
- Handwritten Signatures in Electronic Records
- What is 21 CFR Part 11?
- The Part 11 Guideline
- Narrow Scope and Application of Part 11
- The Benefits of Part 11 Compliance
- E-Signatures NOT Impacted by Part 11
- Electronic Records — Key Requirements
- System Validation for Part 11 Compliance
- Anatomy of a Compliant Audit Trail
- Audit Trail Review — Roles and Frequency
- Audit Trail — What FDA Looks For in Inspection
- Independent vs. User-Editable Audit Trails
- Audit Trail Lifecycle — From Capture to Archive
- Audit Trail Failure to Warning Letter
- Audit Trails Across GxP Systems
- Closed Systems Under §11.10
- Open Systems Under §11.30 — Additional Controls
- Cloud and SaaS — Closed or Open?
- Vendor Audit Checklist for Cloud Part 11 Systems
- Hybrid Systems — Where Part 11 Lives
- GAMP 5 Software Categories
- Risk-Based Validation Lifecycle
- Vendor Qualification and Supplier Assessment
- OQ Test Scripts Specific to Part 11 Functions
- Periodic Review — Keeping Systems in a Validated State
- Change Control and Configuration Management
- Validation Deliverables Matrix
- FDA's CSA Initiative — Computer Software Assurance
- Two-Factor Non-Biometric E-Signature — How It Works
- Biometric Signatures — Implementation Options
- §11.50 Signature Manifestation Requirements
- §11.70 Signature / Record Linking
- §11.300 ID Codes and Password Controls
- Letter of Certification to FDA — §11.100(c)
- ALCOA+ — The Data Integrity Principles
- Mapping ALCOA+ to Part 11 Controls
- Common Data Integrity Violations and the Part 11 Gap Behind Each
- Data Integrity Guidance — Global Crosswalk
- Quality Culture — The Control That Underwrites All Others
- Anatomy of an FDA Inspection — Part 11 Focus
- FDA 483 / Warning Letter Trends — Part 11 & Data Integrity
- Inspection Readiness — 90-Day Pre-Inspection Checklist
- Responding to a Form 483
- Implementing Part 11 in MES / EBR Systems
- Implementing Part 11 in LIMS
- Implementing Part 11 in EDMS / Document Management
- Implementing Part 11 in ERP (SAP, Oracle, etc.)
- AI / ML Systems Under Part 11
- Cloud Migration — Part 11 Considerations
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to FDA 21 CFR Part 11, FDA 2003 Scope and Application Guidance, FDA 2018 Data Integrity Q&A, FDA 2022 CSA Draft Guidance, EU GMP Annex 11, MHRA GxP Data Integrity, and PIC/S PI 041-1 as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by life-sciences regulatory affairs experts and practitioners to ensure that learners can apply Part 11 controls in real GxP electronic systems. Every module follows the same pedagogical rhythm — concept cards, regulatory clauses, real case studies (Ranbaxy, Cetero), audit-flag warnings, system-by-system implementation guidance, a global crosswalk, and a scenario knowledge check.
Our Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
Best Seller
