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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: validation


(77 Programs Found)

Certification Training Validation: Equipment Cleaning Validation
Individual Course w/Certificate of Completion:

Validation: Equipment Cleaning Validation

This online program offers an introduction to the international principles and regulations behind equipment cleaning validation. Manufacturers of medicines and healthcare products must establish, vali …
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Course ID: VAL08
Average Learning Time: 90 minutes
Price: $195 | Enroll Now >>
Certification Training Validation: Introduction to Validation
Individual Course w/Certificate of Completion:

Validation: Introduction to Validation

Validation of equipment, services, systems and processes is vitally important in the medicines and healthcare products industries. Regulatory authorities require documented evidence that manufacturing …
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Course ID: VAL01
Average Learning Time: 90 minutes
Price: $195 | Enroll Now >>
Certification Training Validation: Plans and Documentation
Individual Course w/Certificate of Completion:

Validation: Plans and Documentation

Essential to validation is the provision of documented evidence verifying that manufacturing processes will consistently result in products meeting predetermined quality standards. This program descri …
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Course ID: VAL02
Average Learning Time: 90 minutes
Price: $195 | Enroll Now >>
Certification Training Pharmaceutical Validation Management Professional Certification Program
Professional Certification Program:

Pharmaceutical Validation Management Professional Certification Program

The Pharmaceutical Validation Management Professional Certification Program includes an introduction to the principles behind the international regulations which are assuring effective validation and …
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Course ID: VAL00S1
Average Learning Time: See Program Webpage
Price: $1299 | Enroll Now >>
Certification Training Software Validation Assurance (SVA) Professional Certification Program
Professional Certification Program:

Software Validation Assurance (SVA) Professional Certification Program

The objectives of this professional certification are to give learners a strong understanding for the principles of Software Validation Assurance (SVA), overview of Computer Systems Validation (CSV) a …
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Course ID: SVPRO
Average Learning Time: See Program Webpage
Price: $1395 | Enroll Now >>
Certification Training Process Validation: Introduction to Process Validation - Part 1 of 2
Individual Course w/Certificate of Completion:

Process Validation: Introduction to Process Validation – Part 1 of 2

In this course you will learn about general terms used in process validation. We will explain why processes are validated, and will review regulations associated with process validation. It will also …
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Course ID: ELM-401
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Introduction to Cleaning Validation
Individual Course w/Certificate of Completion:

Introduction to Cleaning Validation

This course has been created for anyone who is interested in learning more about cleaning validation within a regulated environment. If you would like to expand your knowledge of cleaning validation, …
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Course ID: ELM-601
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training MedDev: Introduction to Medical Device Validation (Part 3 of 3)
Individual Course w/Certificate of Completion:

MedDev: Introduction to Medical Device Validation (Part 3 of 3)

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-158
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Process Validation: Introduction to Process Validation - Part 2 of 2
Individual Course w/Certificate of Completion:

Process Validation: Introduction to Process Validation – Part 2 of 2

In the second part of our program on process validation, you will learn in more detail, the different steps that constitute process validation. We will look at the qualification of equipment and the s …
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Course ID: ELM-402
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Validation: Computer System Validation (Part 2 of 2) (Implementation)
Individual Course w/Certificate of Completion:

Validation: Computer System Validation (Part 2 of 2) (Implementation)

This online training program builds upon Computer Systems Validation Part l (VAL09). It offers an introduction to computer systems validation as required by GxP regulations. This course describes the …
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Course ID: VAL10
Average Learning Time: 60 minutes
Price: $195 | Enroll Now >>
Certification Training Validation: Computer System Validation (Part 1 of 2) (Planning)
Individual Course w/Certificate of Completion:

Validation: Computer System Validation (Part 1 of 2) (Planning)

This online program offers an introduction to the international principles and regulations behind computer systems validation. Course objectives include the following: to offer an understanding the co …
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Course ID: VAL09
Average Learning Time: 60 minutes
Price: $195 | Enroll Now >>
Certification Training MedDev: Introduction to Medical Device Validation (Part 2 of 3)
Individual Course w/Certificate of Completion:

MedDev: Introduction to Medical Device Validation (Part 2 of 3)

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-157
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Validation: Introduction to Software Validation (Part 2 of 2)
Individual Course w/Certificate of Completion:

Validation: Introduction to Software Validation (Part 2 of 2)

The main objectives of this course are to give learners a grounding in the principles of Software Validation, Computer Systems Validation and the documentation associated with a complete Software Vali …
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Course ID: ELM-119
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Validation: Introduction to Software Validation (Part 1 of 2)
Individual Course w/Certificate of Completion:

Validation: Introduction to Software Validation (Part 1 of 2)

This course focuses on software validation for support systems… that is, the systems used to develop, deliver, measure, maintain, or assess products such as, Document Management Systems (DMS), Manuf …
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Course ID: ELM-113
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Process Validation for Professionals
Training Program For Professionals:

Process Validation for Professionals

In this Process Validation for Professionals program, students will learn about general terms used in process validation. We will explain why processes are validated, and will review regulations assoc …
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Course ID: PVPRO
Average Learning Time: See Program Webpage
Price: $345 | Enroll Now >>
Certification Training CSV: Computer System Validation - The Master Validation Plan (MVP)
Individual Course w/Certificate of Completion:

CSV: Computer System Validation – The Master Validation Plan (MVP)

This course is geared specifically towards those individuals that will perform computer system validation. A certain understanding of software is important to be proficient in CSV but we’ve tried to p …
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Course ID: ELM-163
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Application of the Validation Plan
Individual Course w/Certificate of Completion:

CSV: Application of the Validation Plan

Regulations set forth by the FDA establish an expectation that all aspects of a regulated manufacturing process are well-established, documented, and controlled to ensure consistent high-quality produ …
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Course ID: ELM-164
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Validation Testing - Part 1
Individual Course w/Certificate of Completion:

CSV: Validation Testing – Part 1

This course is geared specifically towards those individuals that will perform computer system validation. A certain understanding of software is important to be proficient in CSV but we’ve tried to p …
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Course ID: ELM-165A
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Validation Testing - Part 2
Individual Course w/Certificate of Completion:

CSV: Validation Testing – Part 2

This course is geared specifically towards those individuals that will perform computer system validation. A certain understanding of software is important to be proficient in CSV but we’ve tried to p …
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Course ID: ELM-165B
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Computer System Validation (CSV) Professional Certification Program
Professional Certification Program:

Computer System Validation (CSV) Professional Certification Program

The Computer System Validation (CSV) Professional Certification Program will describe how to implement compliance systems in a cloud environment to meet FDA and European regulatory requirements. We wi …
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Course ID: CSVPRO
Average Learning Time: See Program Webpage
Price: $1495 | Enroll Now >>
Certification Training Computer System Validation for Professionals
Training Program For Professionals:

Computer System Validation for Professionals

Computer System Validation for Professionals program includes an introduction to the international principles and regulations behind effective validation and qualification. The program offers an intro …
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Course ID: VAL00S2
Average Learning Time: See Program Webpage
Price: $695 | Enroll Now >>
Certification Training Computer Software Validation for Beginning Professionals
Training Program For Professionals:

Computer Software Validation for Beginning Professionals

Computer Software Validation for Beginning Professionals is designed for those who have started working in a GxP regulated environment and are responsible for managing computer software. As in many re …
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Course ID: CSVBEG
Average Learning Time: See Program Webpage
Price: $495 | Enroll Now >>
Certification Training ISO 13485:2016 - Product Realization (Chapter 7 - Part B)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Product Realization (Chapter 7 – Part B)

The primary part of the purchasing requirements for ISO 13485 is to ensure that purchased product conforms to specified purchasing information, which can essentially be broken down into three subsecti …
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Course ID: ELM-806
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training MedDev: Introduction to Medical Device Validation (Part 1 of 3)
Individual Course w/Certificate of Completion:

MedDev: Introduction to Medical Device Validation (Part 1 of 3)

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 …
(Learn more)

Course ID: ELM-156
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Computer System Validation - Basic Concepts & GAMP®5
Individual Course w/Certificate of Completion:

CSV: Computer System Validation – Basic Concepts & GAMP®5

Upon completion of this course you will be able to, understand the importance of computer system validation, the regulations and standards behind CSV, recommendations and best practices for CSV, under …
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Course ID: ELM-132
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Computer System Validation - The Regulated Software Life Cycle
Individual Course w/Certificate of Completion:

CSV: Computer System Validation – The Regulated Software Life Cycle

Upon completion of this course you will understand the waterfall and agile approach to development, design, validation and verification, the difference between commercial and in-house software, suppor …
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Course ID: ELM-133
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Commissioning, Qualification & Validation the Concept of CQV - Part 3
Individual Course w/Certificate of Completion:

Commissioning, Qualification & Validation the Concept of CQV – Part 3

This course is part of a complete program on Commissioning, Qualification, and Validation, which includes the following individual courses intended for completion in the order listed, overview and ris …
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Course ID: ELM-183
Average Learning Time: 30 minutes
Price: $199 | Enroll Now >>
Certification Training Medical Device Validation for Professionals
Training Program For Professionals:

Medical Device Validation for Professionals

This Medical Device Validation for Professionals program will be beneficial to all personnel directly involved in medical device validation. This includes new employees and seasoned operational person …
(Learn more)

Course ID: MDVAL
Average Learning Time: See Program Webpage
Price: $495 | Enroll Now >>
Certification Training Validation: Commissioning and Installation Qualification (IQ)
Individual Course w/Certificate of Completion:

Validation: Commissioning and Installation Qualification (IQ)

This online program offers an introduction to the international principles and regulations behind commissioning and installation qualification (IQ). Before equipment can be used routinely in productio …
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Course ID: VAL03
Average Learning Time: 90 minutes
Price: $195 | Enroll Now >>
Certification Training Validation: The Life Cycle of a Software Validation Protocol
Individual Course w/Certificate of Completion:

Validation: The Life Cycle of a Software Validation Protocol

In many regulated environments both product software and software that could impact product quality are expected to be validated. The scope of this course is intended to focus on the development and e …
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Course ID: ELM-111
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Computer System Validation - Requirements: The Basis for Validation
Individual Course w/Certificate of Completion:

CSV: Computer System Validation – Requirements: The Basis for Validation

Whether you’re developing a system from scratch or purchasing a system, requirements need to be defined. That should be obvious if you’re developing software but maybe not so much if you’re purchasing …
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Course ID: ELM-134
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Microbial Contamination of Pharmaceutical Products - Part 2
Individual Course w/Certificate of Completion:

Microbial Contamination of Pharmaceutical Products – Part 2

Upon completion of this course you will have a greater understanding of the following, the basics of applied pharmaceutical microbiology, the sources of microbial contamination and their control, how …
(Learn more)

Course ID: ELM-706
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training ISO 13485:2016 - Chapter 6: Resource Management
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Chapter 6: Resource Management

The learning objectives for this program are to understand what ISO 13485 is, and what some of the key advantages to an ISO 13485 certification can provide. Also, to provide an in depth understanding …
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Course ID: ELM-804
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Validation: Operational and Performance Qualification (OQ/PQ)
Individual Course w/Certificate of Completion:

Validation: Operational and Performance Qualification (OQ/PQ)

This program offers an introduction to operational qualification (OQ) and performance qualification (PQ). Having undergone Installation Qualification (IQ), before equipment can be used routinely in pr …
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Course ID: VAL04
Average Learning Time: 60 minutes
Price: $195 | Enroll Now >>
Certification Training Validation: Implementing Compliant Systems in the Cloud
Individual Course w/Certificate of Completion:

Validation: Implementing Compliant Systems in the Cloud

In this course, you will learn how to implement compliance systems in a cloud environment to meet FDA and European regulatory requirements. We will outline from a technical perspective the cloud and t …
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Course ID: ELM-118
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Computer System Validation - Risk Management
Individual Course w/Certificate of Completion:

CSV: Computer System Validation – Risk Management

Risk, risk-based approach, risk-based decisions, and on and on. Clearly, expectations are to consider risk. But what does that mean? What does taking a “risk-based approach” to validation mean? In ess …
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Course ID: ELM-162
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: Equipment, Validation, Complaints and Self Inspection
Individual Course w/Certificate of Completion:

GMP: Equipment, Validation, Complaints and Self Inspection

In this course we will discuss why we need to adhere to good manufacturing practices from a Quality Management System perspective, we will discuss GMP in relation to changes to equipment and documenta …
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Course ID: ELM-203
Average Learning Time: 30 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Maintaining the Validated State
Individual Course w/Certificate of Completion:

CSV: Maintaining the Validated State

Changes can be sneaky little things. There are many ways a system can move out of a validated state. Changes directly to the software are the obvious ones that could impact the validated state and pro …
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Course ID: ELM-166A
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Special Topics
Individual Course w/Certificate of Completion:

CSV: Special Topics

This course has been designed to discuss all of the various special topics that exist around computer system validation (CSV) and how to approach them from a solid foundation. In this course we will c …
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Course ID: ELM-167
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Commissioning, Qualification & Validation the Concept of CQV - Part 1
Individual Course w/Certificate of Completion:

Commissioning, Qualification & Validation the Concept of CQV – Part 1

Commissioning, Qualification and Validation (CQV) activities for life science manufacturing facilities, systems, utilities, and equipment are essential for ensuring compliance to regulations and confi …
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Course ID: ELM-181
Average Learning Time: 30 minutes
Price: $199 | 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 cGMP: Quality Assurance and Quality Control (QA/QC)
Individual Course w/Certificate of Completion:

cGMP: Quality Assurance and Quality Control (QA/QC)

This course emphasizes quality assurance and quality control, with respect to good manufacturing practices. Participants explore GMPs as they apply to quality testing, management, manufacturing, and t …
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Course ID: GMP09
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: Good Manufacturing Practices
Individual Course w/Certificate of Completion:

GMP: Good Manufacturing Practices

This accredited online training course will teach you about Good Manufacturing Practice (cGMP) which is a system for ensuring that products are consistently produced and controlled according to qualit …
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Course ID: ELM-103
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated Environment
Individual Course w/Certificate of Completion:

Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated Environment

This course has been created for anyone who is interested in learning more about managing and ensuring integrity of e-records within a regulated environment. If you would like to expand your knowledge …
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Course ID: ELM-125
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training CSV: Supplier Provided Software
Individual Course w/Certificate of Completion:

CSV: Supplier Provided Software

Software is either developed internally or procured from a software developer. There could be the case that you have an internal development team that ‘sells’ development services to other divisions, …
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Course ID: ELM-166B
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Equipment Validation: Introduction to Risk Based Equipment Qualification
Individual Course w/Certificate of Completion:

Equipment Validation: Introduction to Risk Based Equipment Qualification

This course describes how to assess the risks to product quality in the event of a functional failure of equipment used in a pharmaceutical cGMP environment. The risk based qualification assessment de …
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Course ID: ELM-121
Average Learning Time: 60 minutes
Price: $199 | 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 ISO 13485:2016 - Product Realization (Chapter 7 - Part A)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Product Realization (Chapter 7 – Part A)

The learning objectives for this course are to understand what ISO 13485 is, and what some of the key advantages to an ISO 13485 certification can provide. Also, to provide an in depth understanding o …
(Learn more)

Course ID: ELM-805
Average Learning Time: 60 minutes
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
Average Learning Time: 45 minutes
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
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 …
(Learn more)

Course ID: ELM-149A
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Data Integrity: Computer System Validation (CSV) Best Practices
Individual Course w/Certificate of Completion:

Data Integrity: Computer System Validation (CSV) Best Practices

Computer systems validation (CSV) is an area of high focus by regulators. In this course, we’ll discuss CSV best practices in relation to ALCOA+. As we have seen with some of the FDA Warning Letters t …
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Course ID: ELM-154
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Commissioning, Qualification & Validation the Concept of CQV - Part 2
Individual Course w/Certificate of Completion:

Commissioning, Qualification & Validation the Concept of CQV – Part 2

This is the second course in this program and introduces the key concepts around identifying risk, and risk analysis including risk evaluation, mitigation and communication. You should take this cours …
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Course ID: ELM-182
Average Learning Time: 30 minutes
Price: $199 | Enroll Now >>
Certification Training Data Integrity Professional Certification Program
Professional Certification Program:

Data Integrity Professional Certification Program

The Data Integrity Professional Certification Program describes the importance of data integrity, as it is an essential component of product quality and safety to both health authorities and clinical …
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Course ID: DATAINT
Average Learning Time: See Program Webpage
Price: $995 | 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 cGMP for Intermediate Professionals
Training Program For Professionals:

cGMP for Intermediate Professionals

cGMP for Intermediate Professionals teaches students about Good Manufacturing Practice (cGMP), which is a system for ensuring that products are consistently produced and controlled according to qualit …
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Course ID: GMPINTP
Average Learning Time: See Program Webpage
Price: $845 | Enroll Now >>
Certification Training Equipment Qualification for Professionals
Training Program For Professionals:

Equipment Qualification for Professionals

On completion of this Equipment Qualification for Professionals program, students will be able to understand the seven-step approach to supplier qualification, explain how to conduct audits as part of …
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Course ID: EQPRO
Average Learning Time: See Program Webpage
Price: $895 | Enroll Now >>
Certification Training Microbial Contamination of Pharmaceutical Products - Part 1
Individual Course w/Certificate of Completion:

Microbial Contamination of Pharmaceutical Products – Part 1

Upon completion of this course you will have a greater understanding of the following, the basics of applied pharmaceutical microbiology, the sources of microbial contamination and their control, how …
(Learn more)

Course ID: ELM-705
Average Learning Time: 45 minutes
Price: $199 | 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 cGMP: Cleaning and Sanitation
Individual Course w/Certificate of Completion:

cGMP: Cleaning and Sanitation

This Good Manufacturing Practice (GMP) in Cleaning and Sanitation training program offers a comprehensive overview and a solid introduction to cleaning and sanitation, as it relates to the regulator o …
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Course ID: GMP04
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training cGMP:  Introduction to Good Manufacturing Practice for Medicinal Products
Individual Course w/Certificate of Completion:

cGMP: Introduction to Good Manufacturing Practice for Medicinal Products

Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. The rules may be written into law or set out …
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Course ID: CGMP01
Average Learning Time: 90 minutes
Price: $195 | 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 GMP: FDA Inspection Readiness - Part 1 of 3
Individual Course w/Certificate of Completion:

GMP: FDA Inspection Readiness – Part 1 of 3

A significant part of the FDA pre-approval process remains inspection actions by the agency to ensure quality, consistency, and safety. Readiness for these inspections is paramount. Having bullet-proo …
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Course ID: ELM-122
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: FDA Inspection Readiness - Part 2 of 3
Individual Course w/Certificate of Completion:

GMP: FDA Inspection Readiness – Part 2 of 3

Periodically auditing for Good Manufacturing Practice (GMP) observance is a regulatory requirement. This not only involves a methodical understanding of the regulations, but also an insight into how t …
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Course ID: ELM-123
Average Learning Time: 45 minutes
Price: $199 | 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 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 Regulatory Affairs: Orphan Drug Application - EU and US
Individual Course w/Certificate of Completion:

Regulatory Affairs: Orphan Drug Application – EU and US

Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because they are commercially unattractive. Development of such products is successfully enco …
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Course ID: PRA02
Average Learning Time: 90 minutes
Price: $145 | Enroll Now >>
Certification Training Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
Individual Course w/Certificate of Completion:

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies

This course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of …
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Course ID: PRA05
Average Learning Time: 180 minutes
Price: $225 | 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 …
(Learn more)

Course ID: ELM-149B
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)
Individual Course w/Certificate of Completion:

Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)

Part 11 of Title 21 of the US Code of Federal Regulations (21CFR11) sets out requirements that computer systems must meet to satisfy the Food and Drug Administration (FDA), and to assure that electron …
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Course ID: ESR01A
Average Learning Time: 90 minutes
Price: $225 | Enroll Now >>
Certification Training 21 CFR Part 11 - Electronic Records
Individual Course w/Certificate of Completion:

21 CFR Part 11 – Electronic Records

The main objectives of this course are to give learners a grounding in the principles of and latest requirements for Electronic Records and Electronic Signatures (ERES). This online course provides an …
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Course ID: ELM-114
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training 21 CFR Part 11 - 2003 Guidance
Individual Course w/Certificate of Completion:

21 CFR Part 11 – 2003 Guidance

This course covers the August 2003, US FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures- Scope and Application, establishing the enforcement discretion to the regulation, …
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Course ID: ELM-116
Average Learning Time: 30 minutes
Price: $199 | Enroll Now >>
Certification Training Equipment Validation: How to Perform Supplier Qualification
Individual Course w/Certificate of Completion:

Equipment Validation: How to Perform Supplier Qualification

On completion of this course you will be able to understand the seven step approach to supplier qualification, explain how to conduct audits as part of supplier qualification, explain how to use inter …
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Course ID: ELM-107
Average Learning Time: 60 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 Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) - Part 2
Individual Course w/Certificate of Completion:

Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) – Part 2

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-129
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training cGMP: The Principles of GMP (Micro Learning: 2 of 4)
Individual Course w/Certificate of Completion:

cGMP: The Principles of GMP (Micro Learning: 2 of 4)

This is a micro learning course: A 30-minute course designed to introduce new employees or reinforce seasoned employees on GMP guidelines. It is used to encourage awareness of the importance of follow …
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Course ID: CGMP01b
Average Learning Time: 30 minutes
Price: $99 | Enroll Now >>