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Use this form to search course ID, name, description, outline, and objectives. This is a single word or phrase search. You can search courses for things such as “GMP001S1“, “GAMP“, ““, “ALCOA+“, “OQ/PQ“, “Clinical Trials“, “21 CFR Part 820“, “Cleaning Validation“, or “Drug Safety“.


Searching Courses: 21 CFR Part 820


Certification Training 21 CFR Part 820: Medical Device cGMP Professional Certification Program  Professional Certification Program: 

21 CFR Part 820: Medical Device cGMP Professional Certification Program

To achieve a strong understanding of FDA 21 CFR Part 820, and how it applies to the many areas of a medical device manufacturing company, our 21 CFR Part 820: Medical Device cGMP Professional Certific …
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Course ID: MDPRO
PRICE: $2495 | Enroll Now >>
Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 3  Individual Course w/Certificate of Completion: 

GMP: Combination Products (Drugs, Devices and Biologics) – Part 3

This course will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manufacturin …
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Course ID: ELM-147
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart A - General Provisions  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart A – General Provisions

In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonization (ICH), Food and Drug Adminis …
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Course ID: ELM-301
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart B - Quality System Requirements (QSR)  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart B – Quality System Requirements (QSR)

In this program we will learn about the 21 CFR 820 regulations around quality system requirements (QSR). We will also discuss the International Standards Organization (ISO), International Conference o …
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Course ID: ELM-302
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart C - Design Controls  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart C – Design Controls

In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonization (ICH), Food and Drug Adminis …
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Course ID: ELM-303
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart D - Document Controls  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart D – Document Controls

In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonization (ICH), Food and Drug Adminis …
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Course ID: ELM-304
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart E - Purchasing Controls  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart E – Purchasing Controls

In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonization (ICH), Food and Drug Adminis …
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Course ID: ELM-305
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart F - Identification and Traceability  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart F – Identification and Traceability

In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonization (ICH), Food and Drug Adminis …
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Course ID: ELM-306
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart G - Production and Process Controls  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart G – Production and Process Controls

In this course you will learn about how each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations fro …
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Course ID: ELM-307
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart H - Acceptance Activities  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart H – Acceptance Activities

In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonization (ICH), Food and Drug Adminis …
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Course ID: ELM-308
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart I - Nonconforming Products  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart I – Nonconforming Products

In this course you will learn about nonconforming product and product that fails to meet a requirement, need, expectation or obligation and how each manufacturer shall establish and maintain procedure …
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Course ID: ELM-309
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart J - Corrective and Preventive Action  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart J – Corrective and Preventive Action

The Corrective and preventative actions, or CAPA, system is arguably the most important subsystem of the QMS. It is the location where issues are documented and tracked including the sources of identi …
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Course ID: ELM-310
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart K - Labeling and Packaging Control  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart K – Labeling and Packaging Control

Labeling may seem like a relatively simple topic, bit it is a very complicated topic with regards to medical devices. Before we go too far, let’s start with the basic definition of “label”. The term ” …
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Course ID: ELM-311
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart L - Handling, Storage, Distribution and Installation  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart L – Handling, Storage, Distribution and Installation

Just because we designed the product correctly, and made the product correctly, doesn’t mean we are done. Handling, storage, distribution and installation of the product which isn’t done properly can …
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Course ID: ELM-312
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart M - Records  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart M – Records

Records are what we create to provide the evidence that we are following our procedures; therefore, they are extremely critical. It is important to remember that the records we generate must be admiss …
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Course ID: ELM-313
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart N - Servicing  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart N – Servicing

As servicing is not required of all medical devices, this subpart of the regulations is one of the more commonly excluded regulations from an organization’s quality system requirements. That being sai …
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Course ID: ELM-314
PRICE: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 820 Subpart O - Statistical Techniques  Individual Course w/Certificate of Completion: 

GMP: 21 CFR Part 820 Subpart O – Statistical Techniques

By the end of this course you will have learned, how each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and …
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Course ID: ELM-315
PRICE: $199 | Enroll Now >>
Certification Training MedDev: Introduction to Medical Device Validation - Part 1  Individual Course w/Certificate of Completion: 

MedDev: Introduction to Medical Device Validation – Part 1

This training program will be beneficial to all personnel directly involved in medical device validation, as well as new or seasoned operational personnel who will eventually participate in such effor …
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Course ID: ELM-156
PRICE: $199 | Enroll Now >>