Clinical Trials : Preparing for an audit or an inspection

5/5
9
clinical trials audit inspection

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course : 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

Whether you represent investigatory sites, or sponsor or CRO sites, it’s important to prepare for GCP inspection beforehand. Understanding how GCP audits and inspections are performed can make the process easier. As always, the best way to pass GCP inspections is to ensure GCP compliance with relevant regulatory requirements of that region. In the following lessons, we’ve covered in-depth review of inspection processes of different sites which can serve as a guiding tool to understand regulatory processes in GCP inspection.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

 

Curriculum:

 

Lesson 1: Introduction

 

Lesson 2: Preparing for a GCP Inspection

 

Lesson 3: GCP Regulatory Inspection of Sponsor and CRO Sites

 

Lesson 4: GCP Inspection of Investigatory Sites

 

Lesson 5: Post-Inspection Activities

 

Conclusion

 

Glossary

 

Evaluation

Author:

patricia kay
Dr. Patricia Kay
Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She worked as Clinical Research Associate at Pfizer, GSK, AstraZeneca and she takes part in many startups boards.

Reviews:

5/5
9
USD: United States (US) dollar ($)

$60

Buy now
This course includes:
Full lifetime access
Updated content every month
Certificate of completion

GxP-Training Benefits

$60.00

$60.00

We might have this course but it's not displayed online. Please type your email and we will get back to you within 24h

No video yet for this course