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21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
MP3 Download 21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
Carolyn Troiano Carolyn Troiano
$249
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 pharmaceutical laboratory
Kelly Thomas Kelly Thomas
$229
Developing Training in Regulated Environments
MP3 DDownload This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation
Charles H. Paul Charles H. Paul
$995
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
MP3 Download This Webinar will discuss the latest U.S. FDA and European Union requirements on Design History File, and Technical File/Design Dossier
John E Lincoln John E Lincoln
$199
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar
MP3 Download This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees
Carolyn Troiano Carolyn Troiano
$249
Good Clinical Practice (ICH GCP) Course : Core Requirements, Expectations and Challenges
MP3 Download This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements
John E Lincoln John E Lincoln
$595
Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
MP3 Download This webinar will review the applicable regulations, walk you through real-life situations, help you address compliance, and provide practical strategies to mitigate enforcement actions
Travis Austin MacKay Travis Austin MacKay
$299
The Human Error Toolbox: a practical approach to human error
MP3 Download This course offers practical approaches and tools to address human performance issues in GMP related environments
Ginette Collazo Ginette Collazo
$249
FDA Compliance and Enforcement Trends focused on Data Integrity
MP3 Download This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits
Carolyn Troiano Carolyn Troiano
$249
Analytical Method Validation and Transfer
MP3 Download This course will provide a thorough review of regulatory guidelines on method validation and transfer
Kelly Thomas Kelly Thomas
$229
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
Kelly Thomas Kelly Thomas
$1,495
A Culture of Quality is a Competitive Advantage
MP3 Download This webinar will help you to imbed a culture of quality throughout your organization. We will discuss concepts for creating a culture of quality
Susanne Manz Susanne Manz
$299
Preventing Human Error in the Life Sciences
MP3 Download This eight-hour 4-hour per day virtual seminar, will explore the true causes and nature of human error
Charles H. Paul Charles H. Paul
$1,295
Post Market Surveillance - Complaint Handling and Medical Device Reporting
MP3 Download This webinar will cover the basics of complaint management and medical device reporting
Susanne Manz Susanne Manz
$299
Design Controls for Medical Devices
MP3 Download This 3-hour webinar will cover the basics of design controls for medical devices
Susanne Manz Susanne Manz
$299
FDA Compliance and Mobile Applications Best Practices for Ensuring Compliance
MP3 Download You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed
Carolyn Troiano Carolyn Troiano
$249
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
MP3 Download 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.
David Nettleton David Nettleton
$1,995
6 Hours Annual Online Human Error Certification Training Program
MP3 Download this training would provide tools that can be implemented and used after this event.
Ginette Collazo Ginette Collazo
$499
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
Barry A. Friedman Barry A. Friedman
$385
FDA's Recent Regulation on the Use of Social Media - What It Is, How to Analyze It, Make It Work for You
MP3 Download This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products
Carolyn Troiano Carolyn Troiano
$249
Death by CAPA - Does your CAPA Program need a CAPA?
MP3 Download This seminar will cover regulatory expectations, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls
Susanne Manz Susanne Manz
$850
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.
Karl M. Nobert Karl M. Nobert
$1,295
U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
MP3 Download This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3
John E Lincoln John E Lincoln
$499
A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19— Complaint Handling, MDR Reporting and Recalls
MP3 Download This course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.
Kelly Thomas Kelly Thomas
$1,495
Computer System Validation ( CSV) 3 Day Seminar
MP3 Download 3 day CSV course will teach you how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
Carolyn Troiano Carolyn Troiano
$2,950
Supervising a Human Error Free Environment: You can do a Lot More than you Think
MP3 Download How can we prevent human error? This 90 -minutes online course will discuss why supervision is so important in reducing and preventing human error
Ginette Collazo Ginette Collazo
$179
Dealing with Out of Specification Test Results in FDA Regulated Industries
MP3 Download This webinar with a thorough knowledge on what is allowed and what is not allowed and areas that need to be looked at for a thorough investigation
Meena Chettiar Meena Chettiar
$199
Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing
MP3 Download Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing
Carolyn Troiano Carolyn Troiano
$249
Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies
MP3 Download This webinar will provide a step by step approach and valuable tips for setting up a Quality System to withstand FDA Audits
Meena Chettiar Meena Chettiar
$199
Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment
This live training will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase
Barry A. Friedman Barry A. Friedman
$299
FDA Recalls - Before You Start, and After You Finish
MP3 Download this seminar will help you to Understand FDA's recall authority and policy , Learn how to manage recalls under FDA oversight.
Kelly Thomas Kelly Thomas
€1.595
FDA’s Import Alerts
MP3 Download This webinar will provide attendees with background about FDA Import Alerts, examine why they are issues
Karl M. Nobert Karl M. Nobert
$299
The Validation Master Plan - The Unwritten Requirements
MP3 Download This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S
John E Lincoln John E Lincoln
$199
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.
Barry A. Friedman Barry A. Friedman
$199
Non-conforming Materials in a Medical Device Company – dealing with in-house to field issues
MP3 Download Join industry expert Susanne Manz to learn online the essentials of dealing with non-conforming material and performing effective failure
Susanne Manz Susanne Manz
$399
GMPs for the Life Sciences – 12-Hour Virtual Seminar
MP3 Download This training will provide foundation to your GMP training.
Charles H. Paul Charles H. Paul
$1,295