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Product image for 2 Day Virtual Seminar on FDA Inspection Essentials in 2022

2 Day Virtual Seminar on FDA Inspection Essentials in 2022

MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol

Course•By Danielle DeLucy

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Product image for 2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

MP3 Download This 2 day seminar will go into the specifics of the REACH and RoHS regulations

Course•By Kelly Eisenhardt

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Product image for 3 Hrs Virtual Webinar on Aseptic Processing and Validation

3 Hrs Virtual Webinar on Aseptic Processing and Validation

MP3 Download This course will provide an overview of requirements for aseptic and bulk manufacturing operations, including facility design and contamination

Course•By Kelly Thomas

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Product image for 3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

MP3 Download This webinar will review the regulatory requirements for investigating an OOS Investigation.

Course•By Danielle DeLucy

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Product image for 3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

MP3 Download This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software

Course•By Jose Mora

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Product image for 6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

On Demand Webinar Duration 360 minutes

Course•By Peggy J. Berry

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Product image for 21 CFR Part 11 Compliance for SaaS/Cloud Application

21 CFR Part 11 Compliance for SaaS/Cloud Application

MP3 Download This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors

Course•By David Nettleton

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Product image for 2024 Human Error Prevention & GMP Training Course - New

2024 Human Error Prevention & GMP Training Course - New

MP3 Download this training would provide tools that can be implemented and used after this event.

Course•By Ginette Collazo

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Product image for EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

MP3 Download This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share le

Course•By Kelly Thomas

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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 Analytical Methods Validation for FDA Compliance

Analytical Methods Validation for FDA Compliance

Jan 14-15 In this course, general guideline for the determination of the analytical

Course•By Kelly Thomas

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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 Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

MP3 Download this course we will review how quality systems helps in defining requirements for cleanrooms

Course•By Danielle DeLucy

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Product image for Basic GMP Training for the QC Laboratory

Basic GMP Training for the QC Laboratory

MP3 Download This course will provide participants with an understanding of how to effectively handle out-of-specification

Course•By Kelly Thomas

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Product image for Biostatistics for the Non-Statistician

Biostatistics for the Non-Statistician

Sep 16-18 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 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 cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

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

MP3 Download 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 Clinical Data Management Training

Clinical Data Management Training

MP3 Download Duration 2 Day

Course•By Elaine Eisenbeisz

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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 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 Current regulatory thinking on Data Integrity in 2020

Current regulatory thinking on Data Integrity in 2020

MP3 Download Duration 2 Days

Course•By Carolyn Troiano

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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 Efficient Batch Record Review and Product Release Course

Efficient Batch Record Review and Product Release Course

MP3 Download Duration 240 Minutes

Course•By Danielle DeLucy

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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 FDA Inspection Seminar

FDA Inspection Seminar

MP3 Download This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter

Course•By Kelly Thomas

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Product image for FDA Recalls - Before You Start, and After You Finish

FDA Recalls - Before You Start, and After You Finish

Jan 21-22 This seminar will help you to Understand FDA's recall authority and policy

Course•By Kelly Thomas

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Product image for FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You

FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You

MP3 Download this training will Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S. Pharmaceutical and Biotech.

Course•By Karl M. Nobert

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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 Human Error Tool Box: A practical aproach to human error

Human Error Tool Box: A practical aproach to human error

On Demand Webinar Duration 180 minutes

Course•By Ginette Collazo

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Product image for Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

MP3 Download This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program

Course•By Frank Stein

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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 Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

MP3 Download This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend

Course•By Kelly Thomas

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Product image for Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

MP3 Download this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.

Course•By Kelly Thomas

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Product image for Post-Market Activities in the EU-MDR — A Detailed Analysis

Post-Market Activities in the EU-MDR — A Detailed Analysis

MP3 Download Medical device training will review the new EU-MDR requirements governing Post Market Activities and discuss quality system approaches

Course•By Kelly Thomas

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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 Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

MP3 Download The lifecycle concept, new to these Guidance, link product and process development, qualification

Course•By Barry A. Friedman

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Product image for Project Management for Non-Project Managers in the Life Sciences

Project Management for Non-Project Managers in the Life Sciences

On Demand Webinar Duration 360 minutes

Course•By Charles H. Paul

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Product image for Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

MP3 Download In this two day workshop conference you will learn the requirements and expectation

Course•By Kelly Thomas

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Product image for Quality Control Laboratory Compliance - cGMPs and GLPs

Quality Control Laboratory Compliance - cGMPs and GLPs

MP3 Download This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions

Course•By Kelly Thomas

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Product image for Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training

MP3 Download The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar

Course•By Barry A. Friedman

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Product image for Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

Course•By David Nettleton

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Product image for Regulatory Compliance for Dietary Supplements in the US, EU and Canada

Regulatory Compliance for Dietary Supplements in the US, EU and Canada

Jan 15-16 This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada

Course•By Travis Austin MacKay

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Product image for Risk-based Computer System Validation; Reduce Costs and Avoid 483s

Risk-based Computer System Validation; Reduce Costs and Avoid 483s

This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors

Course•By David Nettleton

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Product image for SOP Writing, Training and Compliance for the Pharmaceutical Industry

SOP Writing, Training and Compliance for the Pharmaceutical Industry

On Demand Webinar Duration 180 minutes

Course•By Michael Esposito

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Product image for Statistical Process Control (SPC) One Day Masterclass

Statistical Process Control (SPC) One Day Masterclass

MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products

Course•By Elaine Eisenbeisz

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Product image for Statistical Process Control (SPC) Training

Statistical Process Control (SPC) Training

MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality

Course•By Elaine Eisenbeisz

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Product image for Supplier and Contract Manufacturer Management

Supplier and Contract Manufacturer Management

MP3 Download 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 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 Understanding the FDA: How to avoid the most recent observations

Understanding the FDA: How to avoid the most recent observations

MP3 Download - Duration 240 Minutes

Course•By Carl Patterson

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Product image for Understanding the Process Validation Life Cycle

Understanding the Process Validation Life Cycle

MP3 Download Duration 90 Minutes

Course•By Danielle DeLucy

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Product image for Verification and Validation - Product, Equipment/Process, Software and QMS

Verification and Validation - Product, Equipment/Process, Software and QMS

MP3 Download This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation

Course•By John E Lincoln

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Product image for Veterinary Drug Approval Process and FDA Regulatory Guidance

Veterinary Drug Approval Process and FDA Regulatory Guidance

MP3 Download This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government

Course•By Karl M. Nobert

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Product image for Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course

Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course

MP3 Download This training course will provide a practical understanding of the requirement for a data governance framework

Course•By Carolyn Troiano

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