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Product image for Computer System Validation ( CSV) 3 Day Seminar

Computer System Validation ( CSV) 3 Day Seminar

Jan 27 - 29 3 day CSV course will teach you how to comply with key FDA and international CSV

Course•By Carolyn Troiano

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Product image for Supplier and Contract Manufacturer Management

Supplier and Contract Manufacturer Management

Feb 18-19 This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification

Course•By Kelly Thomas

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Product image for Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry

Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry

Mar 10-12 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company

Course•By Kelly Thomas

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Product image for cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

Apr 02 This webinar will cover the key areas of how ICH Q7 was established, it's goals and object

Course•By Kelly Thomas

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Product image for Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements

Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements

Apr 09-10 In this accredited training, we will identify and discuss Master Batch Records (MBR), regulatory requirements, and key steps for issuance, batch record review, reconciliation, and final QA disposition

Course•By Kelly Thomas

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Product image for Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

MP3 Download This Course will explain how to comply with key FDA and international CSV regulations

Course•By Carolyn Troiano

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Product image for Global Regulatory Requirements for Drug Safety & Pharmacovigilance

Global Regulatory Requirements for Drug Safety & Pharmacovigilance

MP3 Download This training course is designed to give pharmaceutical and biologic companies

Course•By Steve Jolley

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Product image for EU Clinical Trial Regulation 536/2014: Compliance, Implementation & Best Practices

EU Clinical Trial Regulation 536/2014: Compliance, Implementation & Best Practices

MP3 Download This course covers the requirements for conducting Clinical Studies across the EU

Course•By John E Lincoln

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Product image for Excel Spreadsheet Validation for Part 11 to Eliminate 483s

Excel Spreadsheet Validation for Part 11 to Eliminate 483s

MP3 Download This session will make you a better Excel user, saving you time and costs

Course•By David Nettleton

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Product image for Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)

Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)

MP3 Download In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle

Course•By Carolyn Troiano

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Product image for Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course

Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course

MP3 Download The objective of this live, interactive WCS training seminar is to explore the role of aseptic filling to assure that manufactured product

Course•By Barry A. Friedman

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Product image for Biostatistics for the Non-Statistician

Biostatistics for the Non-Statistician

MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Course•By Elaine Eisenbeisz

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Product image for GMPs for MICROBIOLOGISTS — The Manufacturing Environment

GMPs for MICROBIOLOGISTS — The Manufacturing Environment

MP3 Download The objective of this live, interactive Executive Conference Corp (ECC) webinar is to obtain an enhanced understanding

Course•By Barry A. Friedman

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Product image for Cybersecurity - The Latest US FDA Requirements

Cybersecurity - The Latest US FDA Requirements

MP3 Download This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production by update, the CAPA system, among others

Course•By John E Lincoln

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Product image for The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam

The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam

MP3 Download This webinar will examine a variety of issues surrounding water in a facility to include the testing of each water source.

Course•By Barry A. Friedman

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Product image for 21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

describes exactly what is required for compliance with Part 11

Course•By David Nettleton

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Product image for Technical Writing for professionals in the life sciences

Technical Writing for professionals in the life sciences

MP3 Download This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents

Course•By Charles H. Paul

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Product image for FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

MP3 Download The objective of this live training webinar is to explore the NEW/REVISED Guidances for Industry on Pyrogen and Endotoxins Testing. FDA Training

Course•By Barry A. Friedman

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Product image for Risk Management for AI in Medical Devices – FDA’s TPLC Management Draft Guidance

Risk Management for AI in Medical Devices – FDA’s TPLC Management Draft Guidance

MP3 Download This webinar will cover the FDA’s total product life cycle approach and FDA’s roles and responsibilities in regulating medical devices throughout their lifecycle. The US FDA has long promoted a Risk-Based Total Product Life Cycle (TPLC)

Course•By John E Lincoln

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Product image for FDA Regulations for Tobacco & Tobacco-Related Products – Computer System Validation (CSV), 21 CFR Part 11 (electronic records/signatures), Data Integrity & Compliance

FDA Regulations for Tobacco & Tobacco-Related Products – Computer System Validation (CSV), 21 CFR Part 11 (electronic records/signatures), Data Integrity & Compliance

MP3 Download You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA

Course•By Carolyn Troiano

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Product image for GMP Environmental Monitoring for Pharmaceutical Clean Rooms

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

MP3 Download Attend this webinar to various US and international regulatory requirements, the testing requirements for the various clean room classifications

Course•By John E Lincoln

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Product image for FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

MP3 Download This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pha

Course•By Kelly Thomas

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Product image for Technical Writing for Technical Personnel (In a Regulated Industry)

Technical Writing for Technical Personnel (In a Regulated Industry)

MP3 Download Technical writing is a specialized form of writing often used by an organization's SME"s

Course•By John E Lincoln

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Product image for The Quality System Regulation (cGMP 820) and the new QMSR

The Quality System Regulation (cGMP 820) and the new QMSR

MP3 Download This webinar will discuss what the new QMSR will require. A key element is the incorporation of ISO 13485 into the new 820 by reference

Course•By John E Lincoln

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Product image for Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control

Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control

MP3 Download In this webinar, we’ll discuss on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions

Course•By Carolyn Troiano

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Product image for FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges

FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges

MP3 Download In this two day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.

Course•By Carolyn Troiano

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Product image for SPC (Statistical Process Control) / Control Charts

SPC (Statistical Process Control) / Control Charts

MP3 Download This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC)

Course•By John E Lincoln

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Product image for Generative AI in Drug Discovery

Generative AI in Drug Discovery

MP3 Download The use of Generitive AI in the Drug Development Process. The US FDA's encouragement of AI technology in pharma development and clinicals.

Course•By John E Lincoln

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Product image for Drug Development: Key to Success from Concept to Commercialization

Drug Development: Key to Success from Concept to Commercialization

MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies

Course•By Karl M. Nobert

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Product image for Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

MP3 Download This virtual seminar will address those project management critical tasks within each project phase that must be performed

Course•By Charles H. Paul

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Product image for Computer System Validation for Cloud and COTS Applications–Live, Online Training

Computer System Validation for Cloud and COTS Applications–Live, Online Training

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Course•By Carolyn Troiano

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Product image for US Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates What You Must Know and Do

US Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates What You Must Know and Do

MP3 Download This 120 minute training will review the dietary supplement regulations and discuss how to verify that your products

Course•By Travis Austin MacKay

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Product image for Pharmaceutical Document Management Training Course - A Global Regulatory Approach

Pharmaceutical Document Management Training Course - A Global Regulatory Approach

MP3 Download This course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries

Course•By Kelly Thomas

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Product image for NEW: " New Predetermined Change Control Plans (PCCP) for Medical Devices

NEW: " New Predetermined Change Control Plans (PCCP) for Medical Devices

MP3 Download This webinar will discuss the FDA's draft guidance recommendations for PCCPs as part of 510(k) or PMA submissions where future device changes are basically known

Course•By John E Lincoln

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Product image for Introduction to Computer System Validation

Introduction to Computer System Validation

MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology

Course•By Carolyn Troiano

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Product image for Inspection and Audit Readiness Training for Medical Device Manufacturers

Inspection and Audit Readiness Training for Medical Device Manufacturers

MP3 Download This webinar will focus on how to prepare domestic and foreign medical device manufacturers selling to the U.S. to recognize and prepare for FDA pre- and post-market inspections

Course•By John E Lincoln

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Product image for Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)

Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)

MP3 Download This seminar will describe the requirements, the dos and don’ts commonly

Course•By John C. Fetzer

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Product image for CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

MP3 Download Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations

Course•By John E Lincoln

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Product image for GAMP® 5 Second Edition – The changes and its impacts that you should know

GAMP® 5 Second Edition – The changes and its impacts that you should know

MP3 Download Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition

Course•By Carolyn Troiano

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Product image for Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity

Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity

MP3 Download This has resulted in the FDA focusing on the subset of software functions dealing

Course•By John E Lincoln

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Product image for 21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

MP3 Download This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations

Course•By Carolyn Troiano

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Product image for Good Clinical Practices and Good Laboratory Practices

Good Clinical Practices and Good Laboratory Practices

MP3 Download This webinar will examine the basic requirements of the GLPs and GCP’s and related / supporting requirements

Course•By John E Lincoln

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Product image for All About Data Integrity by Design

All About Data Integrity by Design

MP3 Download The course provides insight into the ways in which Pharma 4.0™ will serve as an enabler for next generation medicinal products and new business cases for established products

Course•By Carolyn Troiano

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Product image for Good Manufacturing Practices (GMP) Online Course

Good Manufacturing Practices (GMP) Online Course

MP3 Download Our 4 Half-days long GMP training will equip you to increase your efficiency and strengthen your skills for a stellar career in the industry. Whether you want to level up your designation or become an entrepreneur, the credibility of a GMP course will only add stars to your portfolio.

Course•By Kelly Thomas

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Product image for How to Prepare for and Host an FDA Inspection and Respond to 483's

How to Prepare for and Host an FDA Inspection and Respond to 483's

MP3 Download This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview

Course•By Edwin Waldbusser

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Product image for Understanding How Quality Management Works

Understanding How Quality Management Works

MP3 Download This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how most QMS' requirements build upon that foundation

Course•By John E Lincoln

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Product image for Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit

Course•By Michael Ramcharan

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Product image for Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

MP3 Download This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs)

Course•By Kelly Thomas

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Product image for Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity

Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity

MP3 Download The attendee will learn about ways to approach the computer system validation of any FDA-regulated system. There are traditional methods that have been followed for decades now, but these document-driven efforts

Course•By Carolyn Troiano

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Product image for Device Changes, FDA Changes, and the 510(k)

Device Changes, FDA Changes, and the 510(k)

MP3 Download In this webinar you will learn What approaches are required for product changes; for process changes

Course•By John E Lincoln

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Product image for Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements

Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements

MP3 Download In this webinar he will also discuss the consideration of the FDA’s concerns over which device functions

Course•By John E Lincoln

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Product image for Useful Statistical Methods for Defining Product and Process Specifications

Useful Statistical Methods for Defining Product and Process Specifications

MP3 Download This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications

Course•By Steven Wachs

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Product image for Preparing for and Managing Successful FDA Inspections

Preparing for and Managing Successful FDA Inspections

Sep 03-04 This seminar, you will learn how to properly alert key members that an investigator

Course•By Danielle DeLucy

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Product image for Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense

Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense

MP3 Download You will learn the why and how of the scientific method, and how to view the world

Course•By Elaine Eisenbeisz

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