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Introduction to Software Validation Assurance

 5/5

13

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Navigate the complexities of software validation with this comprehensive, interactive course, tailored to meet FDA requirements. Gain insights into crucial elements of the software validation lifecycle, from initial planning and risk management to the creation of validation master plans and software system requirements.

Designed by a team of experienced quality assurance and validation experts from the pharmaceutical industry, the course delivers practical knowledge grounded in real-world applications. Ideal for professionals in life sciences organizations, this course enhances your understanding of software validation processes, helping you meet regulatory standards.

Upon successful completion of the course, you will receive a recognized certificate, confirming your expertise in this critical area of quality assurance.

Curriculum:

Introduction: The What and Why of Software Validation Assurance

Lesson 1: Planning for Software Validation

Lesson 2: Navigating Risk in Software Validation

Lesson 3: Crafting a Robust Validation Master Plan

Lesson 4: Defining Software System Requirements

Glossary

Evaluation

Elevate your career and organizational standards with a certified understanding of software validation assurance. Enroll now.

Author:

Dr. Ciaran McEnister

Senior Pharmaceutical Executive with 25+ years of experience in Medical Device Development, Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager.

Reviews:

 5/5

13

This course on software validation was nothing short of eye-opening for me. The interactive, online format made what could be a complex subject matter quite digestible. Each lesson was well-structured, starting with an overview of what software validation is and why it's essential, particularly in the life sciences industry where compliance with FDA requirements is a must.

$60

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This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.