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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 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 Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

MP3 Download This webinar will discuss current US Federal law on the 510(k), IDE, DeNovo, and PMA and associated requirements for getting a new or substantially changed medical device through the US FDA review process and to market in the USA.

Course•By John E Lincoln

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Product image for Cloud and SaaS in GxP Webinar

Cloud and SaaS in GxP Webinar

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 AI in Drug Development

AI in Drug Development

MP3 Download This seminar will evaluate these stated FDA policy shifts as it applies to drug discovery and development.

Course•By John E Lincoln

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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

MP3 Download 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Product image for Risk Management for AI in Medical Devices:  Insights from FDA's Lifecycle Management Draft Guidance

Risk Management for AI in Medical Devices: Insights from FDA's Lifecycle Management Draft Guidance

MP3 Download This webinar will discuss information specific to devices that include artificial intelligence algorithms that make real-world modifications that the agency might require for premarket review

Course•By John E Lincoln

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Product image for ChatGPT / AI for Project Management for FDA-Regulated Companies

ChatGPT / AI for Project Management for FDA-Regulated Companies

MP3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance

Course•By John E Lincoln

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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

Jul 23 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 Human Error Prevention (HEP) - Risk Factors and Strategies

Human Error Prevention (HEP) - Risk Factors and Strategies

MP3 Download This presentation focuses on the use of HEP, HRA and HEART tools to add additional review areas to Risk Management and Human Factors Analysis to effect beneficial

Course•By John E Lincoln

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Product image for GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

MP3 Download This webinar will provide test scripts and rationale for a "model" for internal /self-audits.

Course•By John E Lincoln

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Product image for Microbiological Rapid Method Sterility Testing (RMT) of Short Dated and Other Products

Microbiological Rapid Method Sterility Testing (RMT) of Short Dated and Other Products

MP3 Download The objective of this live, interactive training Executive Conference Corp webinar

Course•By Barry A. Friedman

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Product image for FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

MP3 Download The seminar will cover what you need to do to prepare for an FDA audit, and also the importance and steps required to be certain you have audited all vendors of regulated systems appropriately.

Course•By Carolyn Troiano

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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 Medical software development and regulation - What to consider?

Medical software development and regulation - What to consider?

MP3 Download This compact 90-minute course provides a focused introduction to the development of medical software requirements and a deep understanding of the regulatory requirements resulting

Course•By Frank Stein

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Product image for Preparing the CMC Section for NDAs/INDs/CTDs

Preparing the CMC Section for NDAs/INDs/CTDs

MP3 Download This webinar will discuss current US Federal law on NDAs and INDs and CMC and other associated requirements for getting a new drug through the US FDA review process and to market in the USA.

Course•By John E Lincoln

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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 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 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 US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation

US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation

MP3 Download This seminar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new product development

Course•By John E Lincoln

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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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