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Use this form to search course ID, name, description, outline, and objectives. This is a multiple word search. Each word must be 3 characters or more (e.g., GMP, GCP, Clinical, etc). Shorter words and any special characters (e.g., PQ, OQ, PQ/OQ, /, \, (, ), etc.) will be ignored. You can search courses for things such as GMP001S1, GAMP, Pharmacovigilance, Quality Assurance, ALCOA, Validation, Clinical Trials, CFR Part 820, Cleaning Validation, or Drug Safety.

  


Searching courses for: Drug Safety


(36 Programs Found)

Certification Training Introduction to Drug Safety and Pharmacovigilance
Individual Course w/Certificate of Completion:

Introduction to Drug Safety and Pharmacovigilance

Drug safety monitoring and risk management are vitally important for medicinal product developers, license holders and clinical investigators. In addition to their duty to protect public health, incre …
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Course ID: AV02
Average Learning Time: 180 minutes
Price: $225 | Enroll Now >>
Certification Training Drug Safety and Pharmacovigilance Professional Certification Program
Professional Certification Program:

Drug Safety and Pharmacovigilance Professional Certification Program

The Drug Safety and Pharmacovigilance Professional Certification Program aims to deliver students with a comprehensive overview of the requirements and concepts necessary to attain a strong understand …
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Course ID: AV01
Average Learning Time: See Program Webpage
Price: $695 | Enroll Now >>
Certification Training Clinical Trial Safety Reporting Requirements in the EU and USA
Individual Course w/Certificate of Completion:

Clinical Trial Safety Reporting Requirements in the EU and USA

This course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the fou …
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Course ID: CT14
Average Learning Time: 120 minutes
Price: $225 | Enroll Now >>
Certification Training Safety Reporting in Clinical Trials (Adverse Event Reporting)
Individual Course w/Certificate of Completion:

Safety Reporting in Clinical Trials (Adverse Event Reporting)

This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and h …
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Course ID: CT13
Average Learning Time: 120 minutes
Price: $225 | Enroll Now >>
Certification Training Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration
Individual Course w/Certificate of Completion:

Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration

Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this module we describe the role of in-vivo PK and PD studies in a …
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Course ID: PKPD01
Average Learning Time: 90 minutes
Price: $189 | Enroll Now >>
Certification Training Drug Safety: Signal Detection and Management in Pharmacovigilance
Individual Course w/Certificate of Completion:

Drug Safety: Signal Detection and Management in Pharmacovigilance

The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then ta …
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Course ID: PV04
Average Learning Time: 90 minutes
Price: $195 | Enroll Now >>
Certification Training GMP: 21 CFR Part 211 Subpart E - Control of Components, Drug Product Containers and Closures
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on Control of Components and Drug Product Container …
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Course ID: ELM-206
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Drug Safety: Urgent Safety Restrictions
Individual Course w/Certificate of Completion:

Drug Safety: Urgent Safety Restrictions

In response to a safety signal, a regulatory action, called the Urgent Safety Restriction (USR), is taken. This action is intended to push an interim change to the marketing authorization’s terms for …
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Course ID: PV06
Average Learning Time: 45 minutes
Price: $195 | Enroll Now >>
Certification Training Good Pharmacoepidemiology Practice Professional Certification Program
Professional Certification Program:

Good Pharmacoepidemiology Practice Professional Certification Program

The Good Pharmacoepidemiology Practice Professional Certification Program will provide the student with a comprehensive overview of the requirements and concepts necessary for a strong understanding i …
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Course ID: AV01B
Average Learning Time: See Program Webpage
Price: $995 | Enroll Now >>
Certification Training Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA
Individual Course w/Certificate of Completion:

Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA

The Investigational New Drug Application (IND) is a submission through which the sponsor seeks approval from the Food And Drug Administration (FDA) to conduct clinical studies with an investigational …
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Course ID: GCP007
Average Learning Time: 180 minutes
Price: $225 | Enroll Now >>
Certification Training Drug Safety: Risk Management Planning for Medicinal Products
Individual Course w/Certificate of Completion:

Drug Safety: Risk Management Planning for Medicinal Products

Proactive risk management is a major component of good pharmacovigilance practice (GVP). This course sets out the principles of risk management planning and outlines regulatory requirements for risk m …
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Course ID: PV05
Average Learning Time: 90 minutes
Price: $195 | Enroll Now >>
Certification Training Drug Safety: Good Pharmacoepidemiology Practice
Individual Course w/Certificate of Completion:

Drug Safety: Good Pharmacoepidemiology Practice

Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. It provides a bridge between clinical pharmacology and epidemiology. The increasing demand for real-world …
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Course ID: PV07
Average Learning Time: 60 minutes
Price: $195 | Enroll Now >>
Certification Training GMP: 21 CFR Part 211 Subpart J - Records and Reports
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart J – Records and Reports

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on Records and Reports for drug manufacturing, proc …
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Course ID: ELM-210
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training OSHA: Compressed Gas Safety
Individual Course w/Certificate of Completion:

OSHA: Compressed Gas Safety

Gases for medical use are prescription drugs that must be carefully used, moved, and stored per regulations and guidelines from the Occupational Safety and Health Administration, the National Fire Pro …
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Course ID: OSHA-03
Average Learning Time: 22 minutes
Price: $95 | Enroll Now >>
Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 3 of 3
Individual Course w/Certificate of Completion:

GMP: Combination Products (Drugs, Devices and Biologics) – Part 3 of 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
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Medical Device vs. Drug: Comparing and Contrasting
Individual Course w/Certificate of Completion:

Medical Device vs. Drug: Comparing and Contrasting

This course covers major differences between medical device and drug clinical trials, including key definitions, regulatory approval and application processes, and safety reporting, with a focus on F …
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Course ID: CP010a
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 211 Subpart F - Production and Process Controls
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart F – Production and Process Controls

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on production and process controls for drug manufac …
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Course ID: ELM-208
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 211 Subpart H - Holding and Distribution
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart H – Holding and Distribution

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on holding and distribution of drug products. These …
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Course ID: ELM-207
Average Learning Time: 30 minutes
Price: $199 | Enroll Now >>
Certification Training Pharmaceutical Microbiology Professional Certification Program
Professional Certification Program:

Pharmaceutical Microbiology Professional Certification Program

Upon completion of this Pharmaceutical Microbiology Professional Certification Program, students will have a greater understanding of the following: The basics of applied pharmaceutical microbiology; …
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Course ID: PMPCERT
Average Learning Time: See Program Webpage
Price: $995 | Enroll Now >>
Certification Training Pharmaceutical Contamination Control Professional Certification Program
Professional Certification Program:

Pharmaceutical Contamination Control Professional Certification Program

Contamination is a serious concern for the pharmaceutical industry. The presence of contaminants, such as non-viable particles, micro-organisms and their endotoxins, can reduce or even inactivate the …
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Course ID: PCCP
Average Learning Time: See Program Webpage
Price: $1995 | Enroll Now >>
Certification Training Clinical Trials:  Preparing for an Audit or Inspection
Individual Course w/Certificate of Completion:

Clinical Trials: Preparing for an Audit or Inspection

Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the res …
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Course ID: GCP006
Average Learning Time: 150 minutes
Price: $225 | Enroll Now >>
Certification Training GMP: 21 CFR Part 211 Subpart B - Organization and Personnel
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart B – Organization and Personnel

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on organization and personnel. These regulations a …
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Course ID: ELM-211
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 211 Subpart C - Building and Facilities
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart C – Building and Facilities

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on Building and Facilities for drug manufacturing, …
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Course ID: ELM-205
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: 21 CFR Part 211 Subpart D - Equipment
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart D – Equipment

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations for equipment used for drug manufacturing and relat …
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Course ID: ELM-212
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training FDA Inspection Readiness for Professionals
Training Program For Professionals:

FDA Inspection Readiness for Professionals

FDA Inspection Readiness for Professionals is developed to train employees on how to prepare for an FDA audit or inspection. A significant part of the FDA pre-approval process remains inspection actio …
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Course ID: FDAINSP
Average Learning Time: See Program Webpage
Price: $495 | Enroll Now >>
Certification Training GMP: FDA Inspection Readiness - Part 3 of 3
Individual Course w/Certificate of Completion:

GMP: FDA Inspection Readiness – Part 3 of 3

The US Food and Drug Administration (FDA) is responsible for regulating the safety, efficacy, and quality of therapeutic products that save or improve human lives. Firms looking to approve pharmaceuti …
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Course ID: ELM-124
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) - Part 1
Individual Course w/Certificate of Completion:

Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) – Part 1

Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect that QRM is inherent …
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Course ID: ELM-128
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: China Food and Drug Administration (CFDA) - GMP for Medical Devices
Individual Course w/Certificate of Completion:

GMP: China Food and Drug Administration (CFDA) – GMP for Medical Devices

This course focuses on providing an understanding of the Chinese Food and Drug Administration’s (CFDA’s) Announcement on Good Manufacturing Practices for Releasing Medical Devices, 2014 Number 64. The …
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Course ID: ELM-330
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: China Food and Drug Administration (CFDA) - GMP for Implantable Medical Devices
Individual Course w/Certificate of Completion:

GMP: China Food and Drug Administration (CFDA) – GMP for Implantable Medical Devices

This course focuses on providing an understanding of the Chinese Food and Drug Administration’s (CFDA’s) Announcement on issuing an Appendix of Implantable Medical Devices to Good Manufacturing Practi …
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Course ID: ELM-331
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Microbiological Testing Methods
Individual Course w/Certificate of Completion:

Microbiological Testing Methods

This course focuses providing a basic understanding of microbiological testing methods, including a discussion on how to handle test failures. The purpose of this course is to provide a basic understa …
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Course ID: ELM-721
Average Learning Time: 30 minutes
Price: $199 | Enroll Now >>
Certification Training Microbiological Environmental Monitoring
Individual Course w/Certificate of Completion:

Microbiological Environmental Monitoring

This course focuses providing a basic understanding of microbiological environmental monitoring, including an overview of a variety of monitoring methods. The purpose of this course is to provide a ba …
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Course ID: ELM-719
Average Learning Time: 30 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: Introduction to Good Manufacturing Practices (For Beginners)
Individual Course w/Certificate of Completion:

GMP: Introduction to Good Manufacturing Practices (For Beginners)

Good Manufacturing Practices (GMP) are a set of principles that systematically minimize risks associated primarily with pharmaceutical and medical device production in order to ensure the purity, safe …
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Course ID: ELM-722
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Periodic Review Strategies - Part 1
Individual Course w/Certificate of Completion:

CSV: Periodic Review Strategies – Part 1

This course focuses on providing an understanding of periodic review strategies for validated computer systems, as well as the associated regulations and guidelines affecting these practices. The purp …
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Course ID: ELM-149A
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Periodic Review Strategies - Part 2
Individual Course w/Certificate of Completion:

CSV: Periodic Review Strategies – Part 2

This course focuses on providing an understanding of periodic review strategies for validated computer systems, as well as the associated regulations and guidelines affecting these practices. The purp …
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Course ID: ELM-149B
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline
Individual Course w/Certificate of Completion:

Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline

ICH E8(R1) is the umbrella guideline that maps to all the ICH “E”
family, including ICH E6(R3), Good Clinical Practice. The revision
modernizes clinical trial design, planning, management, conduct,

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Course ID: CP019a
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Investigator Initiated Clinical Trials
Individual Course w/Certificate of Completion:

Investigator Initiated Clinical Trials

What are investigator initiated trials, and are they truly initiated by investigators, or by industry sponsors? Investigators may have an idea for a clinical trial with an investigational or approved …
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Course ID: CP011a
Average Learning Time: 30 minutes
Price: $199 | Enroll Now >>