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Courses

Excel Spreadsheets; everything you need to know to pass a Part 11 inspection
12 Nov This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$190
cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA
13 Nov This webinar will cover the key areas of how ICH Q7 was established, it's goals and object
Kelly Thomas Kelly Thomas
$499
Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
20 Nov This webinar will conforms to the new ISO 62366 standard and the new FDA Guidance document.
Edwin Waldbusser Edwin Waldbusser
$189
FDA & OSHA Warehouse Requirements
21 Nov The webinar will provide attendees with an overview of the FDA’s warehousing regulatory
Karl M. Nobert Karl M. Nobert
$287
Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance
21 Nov 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
Master Validation Plan - The Unwritten Requirements
Nov 25 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
Cybersecurity - The Latest US FDA Requirements
25 Nov 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
$349
Efficient Batch Record Design and Review
Nov 25-26 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
Kelly Thomas Kelly Thomas
$1,295
The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
Nov 26 This seminar will examine the existing and proposed requirements for the U.S. FDA
John E Lincoln John E Lincoln
$795
Technical Writing for professionals in the life sciences
Dec 02-04 This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents
Charles H. Paul Charles H. Paul
$1,495
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
Dec 02-03 In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations
Karl M. Nobert Karl M. Nobert
$1,295
GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries
Dec 02-03 GMP Auditing for the Pharmaceutical Industry
Kelly Thomas Kelly Thomas
$1,295
Good Manufacturing Practices (GMP) Online Course
Dec 02-05 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.
Kelly Thomas Kelly Thomas
$1,995
21 CFR Part 11 - Compliance for Electronic Records and Signatures
03 Dec This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security
Edwin Waldbusser Edwin Waldbusser
$189
Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control
Dec 04 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
Applied Time Series in Healthcare
05 Dec This 4-hour webinar will provide attendees with the theory and application of time series analysis. The main focus will be on autoregressive integrated moving average (ARIMA) techniques
Elaine Eisenbeisz Elaine Eisenbeisz
$499
FDA Inspection Seminar
Dec 03-04 This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter
Kelly Thomas Kelly Thomas
$1,295
The 6 Most Common Problems in FDA Software Validation and Verification
05 Dec This webinar covers the fundamentals of 21 CFR Part 11, software validation
David Nettleton David Nettleton
$190
Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry
Dec 10-12 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company
Kelly Thomas Kelly Thomas
$1,895
The EU Clinical Trial Regulation - EU Filings & Registrations
Dec 05 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln John E Lincoln
$895
2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
Dec 04-05 This 2 day seminar will go into the specifics of the REACH and RoHS regulations
Kelly Eisenhardt Kelly Eisenhardt
$1,899
All About Data Integrity by Design
09-10 Dec 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
Carolyn Troiano Carolyn Troiano
$1,295
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)
Dec 09 In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle
Carolyn Troiano Carolyn Troiano
$287
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training
Dec 10 The objective of this live training webinar is to develop an understanding
Kelly Thomas Kelly Thomas
$349
Analytical Methods Validation for FDA Compliance
Dec 16-18 In this course, general guideline for the determination of the analytical
Kelly Thomas Kelly Thomas
$1,895
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Dec 11-12 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
Supplier and Contract Manufacturer Management
Jan 22-23 This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification
Kelly Thomas Kelly Thomas
$1,295
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
Carolyn Troiano Carolyn Troiano
$1,895
Biostatistics for the Non-Statistician
MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
$1,495
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
Travis Austin MacKay Travis Austin MacKay
$1,895
Quality Control Laboratory Compliance - cGMPs and GLPs Course - What Regulatory, Compliance & Quality Professionals Need to Know
MP3 Download This course will provide an overview of the Regulatory requirements governing QC Labs to ensure compliance with cGMP and GCP
Kelly Thomas Kelly Thomas
$1,295
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
Barry A. Friedman Barry A. Friedman
$1,295
Multiple Linear Regression, Logistic Regression, and Survival Analysis
MP3 Download This seminar provides in-depth training on multiple regression, logistic regression, and Cox regression, equipping you with the essential tools to analyze complex data sets accurately and efficiently.
Elaine Eisenbeisz Elaine Eisenbeisz
$795
FDA Regulation of Artificial Intelligence/ Machine Learning
MP3 Download This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML
Edwin Waldbusser Edwin Waldbusser
$189
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
Barry A. Friedman Barry A. Friedman
$1,295
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
John E Lincoln John E Lincoln
$1,495

Bundles

Pharmacovigilance Certification
Courses: 2
$1,895
US Dietary Supplements Certification
US Dietary Supplements Virtual Course Online
Courses: 3
$1,195
Good Manufacturing Practices (GMP) Certification Course
Online GMP Training courses
Courses: 4
$1,985
Human Error Prevention & GMP Training Course 4 Part Series
4-Part Live Training Webinar Series ( 6hrs)Faculty Ginette Collazo, Ph.D. CEO Human Error Solutions Miami, Florida, United States
Courses: 4
$595
Lyophilization Basics for Pharmaceuticals
8 hrs Instructor-led Virtual Seminar -Lyophilization Pharmaceutical Course
Courses: 2
$1,295