FDA Inspection Readiness – Part 3
Description: The US Food and Drug Administration (FDA) is responsible for regulating the safety,...
Course Code: ELM-124
by: Joginder Mittal
Macro-learning
FDA Inspection Readiness – Part 2
Description: Periodically auditing for Good Manufacturing Practice (GMP) observance is a regulatory requirement. This...
Course Code: ELM-123
by: Joginder Mittal
Macro-learning
FDA Inspection Readiness – Part 1
Description: A significant part of the FDA pre-approval process remains inspection actions by the...
Course Code: ELM-122
by: Joginder Mittal
Macro-learning
Key Process Principles of GMP Audits
Principles relating to audit process include: Independence Auditors must: Be independent of the activity...
Course Code: ELM-122
by: Joginder Mittal
Micro-learning
Key Principles of GMP Audits for Auditors
Observance of the key principles is a prerequisite for providing a reliable and relevant...
Course Code: ELM-122
by: Joginder Mittal
Micro-learning
Anatomy of an Internal Audit (Self Inspection)
Internal audit acts as the organizations eyes and ears to collect feedback for modification...
Course Code: ELM-122
by: Joginder Mittal
Micro-learning
3 Critical Reasons for GMP Auditing
The three main reasons why GMP auditing is so important include the: Safety Aspect...
Course Code: ELM-122
by: Joginder Mittal
Micro-learning
The GMP Audit Defined
What is an Audit? An audit is a methodical, independent and documented process for...
Course Code: ELM-122
by: Joginder Mittal
Micro-learning
11 Key Items to Consider When Conducting a Vendor Audit [Video]
It is good practice to audit your vendor before you decide on which vendor...
Course Code: ELM-127
by: Graham O'Keeffe
Micro-learning
The Difference Between Horizontal & Vertical Auditing [Video]
There are two basic methodologies that are commonly used for conducting audits. Horizontal, or...
Course Code: ELM-122
by: Joginder Mittal
Micro-learning
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