The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.
This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
- FDA Regulatory Oversight
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- GAMP 5 Software Categorization
- System Risk Assessment
- 21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)
- Security, Access, Change Control and Audit Trail
- Validation Documentation
- Policies and Procedures
- Training and Organizational Change Management
- Industry Best Practices and Common Pitfalls
Who Will Benefit
- Information Technology Analysts
- Information Technology Managers
- 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 internal inspection
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 Participants 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
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology 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 NIH, EMA, 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 Compliance, Process 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.