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Regulatory Compliance Inspections and External Audits

 5/5

50

Duration :

1

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:

Compliance with guidelines established by regulatory agencies such as the WHO or the FDA is a key aspect to Good Manufacturing Practice (GMP). Compliance 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

Glossary

Quiz

Author:

Saher Binte Haider

Saher Binte Haider (PharmD) is a pharmacy graduate from Dow University of Health Sciences. She started her career as a Quality Management professional in the pharmaceutical industry where she developed her interest in good documentation practices, SOP creation, and pharmaceutical regulatory compliance. She has 7 years of experience in medical writing. Her key areas of expertise are pharmaceutical regulatory writing, medical and pharmaceutical research, online content creation and strategy, writing on disease states, and pharmacology.

Reviews:

 5/5

50

My team gained sufficient knowledge to maintain perpetual readiness for inspections and audits in the facility. We owe it all to Dokeos!

$60

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This course includes:

Full lifetime 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.