Introduction to Software Validation Assurance

5/5
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Software Validation Assurance

Duration :

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 ourย 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:

ciaran
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 at Merckx, BioDevices and IPSEN.

Reviews:

5/5
13
USD: United States (US) dollar ($) ^

$60

Buy now
This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$60.00 / year

$60.00 / year

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