Regulatory Compliance Inspections and External Audits

4.5/5
53
inspections and audit

Duration :

2

1 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:

Compliance with guidelines established by regulatory agencies such as the WHO or the FDA is a key aspect of Good Manufacturing Practice (GMP). It is enforced by inspections and audits: inspections evaluate two or more systems in the manufacturing loop; audits confirm that the goals of GMP are being met.

In this introduction to the inspection and auditing processes, participants will learn about various types of inspections and about the role of regulatory bodies in ensuring the production of safe and effective drugs and medical devices.

 

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

 

Introduction

 

Lesson 1: Why are Regulatory Compliance Inspections and External Audits Important?

 

Lesson 2: The ICH Q10 Guidelines on Regulatory Inspections

 

  • Achieve Products Realization
  • Establish and Maintain a State of Control
  • Facilitate Continual Improvement

 

Lesson 3: Which Businesses are Subject to Compliance Inspections and External Audits?

 

Lesson 4: Who Monitors and Audits GMP Compliance?

 

  • Regulatory agencies responsible for GMP Audits

 

Lesson 5: Types of Regulatory Compliance Inspections

 

  • Routine Inspection
  • Concise Inspection
  • Follow-up Inspection
  • Special Inspection
  • Quality Systems Review
  • Frequency of Inspections

 

Lesson 6: FDA Guidelines for Compliance Inspection and Audit Strategy

 

  • Quality system
  • Inspection of Quality System (Phase 1 and Phase 2)
  • Product Reviews
  • Compliant Reviews
  • Discrepancy and Failure Investigations (for manufacturing and testing)
  • Change Control
  • Product Improvement Projects
  • Reprocessing
  • Market Returns
  • Rejects
  • Stability Failures
  • Validation
  • Staff Training
  • Facilities and Equipment System
  • Inspection of Facilities and Equipment System
  • Facilities
  • Equipment
  • Materials System
  • Production System
  • Packaging and Labeling System
  • Laboratory Control System

ย 

Glossary

 

Quiz

Author:

Ellena Jefferson
Dr. Jefferson
Dr. Jefferson is a CAPA Manager. She serves as a Training and Quality Advisor with ICONIC plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Dr. Jefferson is a fixer who continuously strives for excellence as a way of life; not just as a job.

Reviews:

4.5/5
53
USD: United States (US) dollar ($) ^

$60

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