GAMP® Data Integrity 21 CFR Part 11 Course Description

The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

Course Modules

Part 1 - The Keys to COTS Computer System Validation - 1 hr - 11 -12 PM EDT

Part 2 - Step-Wise Process for COTS Risk-Based Computer System Validation and Change Control - 1 hr - 12- 1 PM EDT

Break Working Lunch – Discussion and Q&A - 30 mins 01:00 - 01:30 PM EDT

Part 3 - 21 CFR Part 11 Compliance - 1 hr - 01:30 -2:30 PM EDT

Part 4 - Purchasing COTS Software - 1 hr - 02:30 - 03:30 PM EDT

Part 5 - Industry Best Practices - 1 hr - 03:30 - 04:30 PM EDT

Wrap- Up - Q/A - 30 minutes - 4:30 -05:00 PM EDT

What You Will Learn

This training course will provide a practical understanding of the following:

  • The current regulatory focus on Data Integrity
  • Relevant regulatory observations
  • Recent regulatory Guidance on Data Integrity
  • The need for Data integrity throughout the system and data life cycles
  • The requirement for a data governance framework
  • How to meet the international regulatory requirements for electronic records and signatures
  • How to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the FDA interpretation in the Scope and Application Guidance
  • How to meet the requirements of other relevant regulations including EU Annex 11
  • How to apply the current industry risk-based good practice approach to compliant electronic records and signatures
  • How to maintain Data Integrity through the operation phase of the GAMP life cycle
  • How new technologies such as cloud computing and mobile applications can impact data integrity
  • How to apply the new ISPE GAMP Guide: Records and Data Integrity including: 
  • Data Governance Framework
  • Culture and Human Factors
  • Data Life Cycle
  • Applying Quality Risk Management to Data Integrity

Who Will Benefit from Data Integrity Training

  • All those working in a GxP regulated environment that require a working knowledge of data integrity, electronic records and signatures, and the associated operational aspects of GxP computerized systems.
  • Anyone who needs a fundamental understanding of the 21 CFR Part 11 regulation and risk management approaches to achieving electronic record and signature compliance.
  • Computer system vendors or consultants, engineering contractors, and validation service companies.
  • Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations.

Choose a Purchase Option

FDA Faculty Carolyn Troiano

Carolyn Troiano

Midlothian, Virginia, United States

Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.

My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.

My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.

Our Past Seminar Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

Learn More