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Compliance
Certificate Course
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Accredited by IACET/ANSI
This course provides you with the compliance rules, regulations, and functions within a pharmaceutical company for both drug and drug products, and medical devices. The module first discusses the different compliance issues specific to drugs and drug products. Then it presents compliance issues specific to medical devices. The information presented here is important to consider when engaging in clinical development or clinical trials within medical affairs.
4.7 | (500 + Graduates)
$479.99
1 Modules
6 Months Access
100% Online & Self Paced
24/7 Live Chat
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Total Price : $3478.98
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Buy all together : $ 3478.98
Learning Objectives
Define Compliance and First Tier Quality System Related Requirements
Learn about compliance quality system for drugs and biologics & compliance quality system for medical devices
Compliance and Second Tier Related Requirements
Understand the 21 Code of Federal Regulations (CFR) Part 50 – Protection of human subjects domestic, 21 CFR Part 56 – Institutional review board international and 21 CFR Part 58 – Good laboratory practice for non-clinical laboratory studies
Third Tier Related Requirements
Organize a Plan for the Compliance and understand CFR Part 7 – enforcement policy
Drugs & Medical Devices
Understand the different compliance issues specific to drugs and drug products. Then learn about compliance issues specific to medical devices.
Master These Skills
Compliance
Code of federal regulations
Institutional review
Laboratory practice
Enforcement policy
Medical device compliance
Drug issues
Clinical trials
All ACMA certifications are accredited by IACET/ANSI
25k+
Users
80+
Countries
250+
Companies
Module Breakdown
Module 1
Diagnostics Industry
This course provides you with the compliance rules, regulations, and functions within a pharmaceutical company for both drug and drug products, and medical devices. The module first discusses the different compliance issues specific to drugs and drug products. Then it presents compliance issues specific to medical devices. The information presented here is important to consider when engaging in clinical development or clinical trials within medical affairs.
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