Medical Device Single Audit Program (MDSAP) – Part 1
Description: This course will examine the process of preparing and applying for the Medical...
Course Code: ELM-135
by: Ginny Ojingwa
Macro-learning
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
How to Prepare for Internal & External Laboratory Audits
Description: This course will examine the formal laboratory audit from the perspective of the...
Course Code: ELM-106
by: Dr. David Trew
Macro-learning
How to Perform Supplier Qualification
Description: On completion of this course you will be able to understand the seven...
Course Code: ELM-107
by: Don Hurd
Macro-learning
Laboratory Investigations & Deviations
Description: On completion of this course you will be able to, explain the elements...
Course Code: ELM-108
by: Dr. David Trew
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
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