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Biotechnology Online Courses and Training

Get biotechnology online courses from World Compliance Seminars. We offer Compliance Courses, FDA Training from industry experts. Enroll Now


2024 Toxic Substance Control act (TSCA) Basics
MP3 Download This is a one (1) day training course on the Toxic Substance Control Act and the latest developments for 2023
Kelly Eisenhardt Kelly Eisenhardt
$899
Analytical Methods Validation for FDA Compliance
MP3 Download In this course, general guideline for the determination of the analytical
Kelly Thomas Kelly Thomas
$1,295
Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data
MP3 Download This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology
Carolyn Troiano Carolyn Troiano
$189
Building GMP Excellence: A Guide to Implementing Compliant Training Programs
MP3 Download The session discussed GMP regulations, agency expectations, training program responsibilities, new employee requirements, transferred employees, external service providers, events, skills qualification program, assessment, retraining, instructor qualifications, curriculum, documentation, and performance deviations.
Ginette Collazo Ginette Collazo
$189
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)
Kelly Thomas Kelly Thomas
$189
FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
MP3 Download The webinar 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.
Carolyn Troiano Carolyn Troiano
$499
Risk-Based Validation of Spreadsheet Applications
MP3 Deownload This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries
Carolyn Troiano Carolyn Troiano
$189
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
John E Lincoln John E Lincoln
$189
Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance
MP3 Download You’ll learn an approach to both 21 CFR Part 11 and data integrity compliance understanding what FDA expects stakeholders in industry to do. There a few simple suggestions that can streamline validation activities related to all of these key areas.
Carolyn Troiano Carolyn Troiano
$189
Human Error Gen- Human Error Mitigation: Strategies for Enhanced Performance
MP3 Download This training would provide tools that can be implemented and used after this event. These include practical tools
Ginette Collazo Ginette Collazo
$189
QMS 101: Quality Management System Guide
MP3 Download This webinar discusses the key parts of ISO 9001, especially how it applies to manufacturing. However, its principles can, and are, used in many different business activities
John E Lincoln John E Lincoln
$189
Master Validation Plan - The Unwritten Requirements
MP3 Download What is the FDA definition of "risk based" and how is it documented in the V&V test report. Additional recommended supporting systems / documentation
John E Lincoln John E Lincoln
$499
Project Management for Computer System Validation (CSV) to Improve FDA Compliance
MP3 Download We will cover the approach for validating/qualifying infrastructure components to FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions
Carolyn Troiano Carolyn Troiano
$189
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
Carolyn Troiano Carolyn Troiano
$499
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
MP3 Download In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations
Karl M. Nobert Karl M. Nobert
$1,895
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
Carolyn Troiano Carolyn Troiano
$189
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
John E Lincoln John E Lincoln
$189
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
Karl M. Nobert Karl M. Nobert
$1,295
Supervising a Human Error Free Environment: You can do a Lot More than you think
MP3 Download The session will discuss supervision approaches, near root causes and root causes for supervision related errors, and will address the 5 main elements of assuring an error free environment
Ginette Collazo Ginette Collazo
$199
Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA
MP3 Download During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data
Carolyn Troiano Carolyn Troiano
$189
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
Kelly Thomas Kelly Thomas
$1,843
Quality Management 101: Enterprise Maintenance Professional's Guide
MP3 Download This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how a company's preventative and predictive maintenance programs can be enhances by the QMA requirements
John E Lincoln John E Lincoln
$189
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
Carolyn Troiano Carolyn Troiano
$189
Lyophilization Basics for Pharmaceuticals: Unit operations, equipment, instrumentation, and performance
MP3 Download Lyophilization Basics for Pharmaceuticals: Unit operations, equipment, instrumentation, and performance
Lisa Hardwick Thompson Lisa Hardwick Thompson
$695
Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3
MP3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new product development
John E Lincoln John E Lincoln
$189
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
MP3 Download This webinar will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.
Carolyn Troiano Carolyn Troiano
$189
Lyophilization Basics for Pharmaceuticals: History, Scientific Principles, Cycles and Formulations
MP3 Download To learn the how and why for formulating and designing lyophilization cycles for drugs that will benefit from the freeze-drying process
Lisa Hardwick Thompson Lisa Hardwick Thompson
$695
The Most Common Problems in FDA Software Validation & Verification
MP3 Download This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models
John E Lincoln John E Lincoln
$189
Optimizing Efficiency: A Comprehensive Guide to 5S Principles
MP3 Download This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler, and organized
Ginette Collazo Ginette Collazo
$199
FDA Compliance and Clinical Trial Computer System Validation Course
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.
Carolyn Troiano Carolyn Troiano
$1,895
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
Carolyn Troiano Carolyn Troiano
$287
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
John C. Fetzer John C. Fetzer
$1,495
Trial Master File and Clinical Data Management Regulated by FDA
MP3 Download This FDA compliance training will cover in detail the new requirements for trial master files
Carolyn Troiano Carolyn Troiano
$189
Risk Management of Raw Materials in a GMP Environment
MP3 Download The live training webinar will explore the number of lots required to be tested before reduced testing might occur
Barry A. Friedman Barry A. Friedman
$1,199
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
MP3 Download This webinar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles
John E Lincoln John E Lincoln
$1,895
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
John E Lincoln John E Lincoln
$198