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Courses

Basic GMP Training for the QC Laboratory
Oct 9-10 This course will provide participants with an understanding of how to effectively handle out-of-specification
Kelly Thomas Kelly Thomas
$1,295
The FDA Inspection From SOP to 483
Oct 16 This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection
Jose Mora Jose Mora
$189
Supplier and Contract Manufacturer Management
17-18 Oct 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
FDA Recalls - Before You Start, and After You Finish
21-22 Oct this seminar will help you to Understand FDA's recall authority and policy
Kelly Thomas Kelly Thomas
$1,495
Medical Device Software Validation Meeting FDA Regulations
22 Oct This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product
Edwin Waldbusser Edwin Waldbusser
$189
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Oct 22-23 The lifecycle concept, new to these Guidance, link product and process development, qualification
Barry A. Friedman Barry A. Friedman
$1,495
Verification and Validation - Product, Equipment/Process, Software and QMS
29-30 Oct 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
Computer System Validation ( CSV) 3 Day Seminar
Nov 4-6 3 day CSV course will teach you how to comply with key FDA and international CSV
Carolyn Troiano Carolyn Troiano
$1,895
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course
06-07 Nov 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
FDA Regulation of Artificial Intelligence/ Machine Learning
06 Nov This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML
Edwin Waldbusser Edwin Waldbusser
$189
Multiple Linear Regression, Logistic Regression, and Survival Analysis
06 Nov 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
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
06-07 Nov The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar
Barry A. Friedman Barry A. Friedman
$1,295
Quality Control Laboratory Compliance - cGMPs and GLPs Course - What Regulatory, Compliance & Quality Professionals Need to Know
Nov 07-08 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
Biostatistics for the Non-Statistician
07-08 Nov this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
$1,295
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
Efficient Batch Record Design and Review
Nov 11-13 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
$1,895
All About Data Integrity by Design
13-14 Nov 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
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
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
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
$2,450
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
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
$189
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
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
Kelly Eisenhardt Kelly Eisenhardt
$1,899
How to Prepare for and Host an FDA Inspection and Respond to 483's
MP3 Download This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview
Edwin Waldbusser Edwin Waldbusser
$189
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
MP3 Download This eight-hour vendor qualification audit training will help you improve
Kelly Thomas Kelly Thomas
$1,295
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
This webinar describes exactly what is required for compliance with Part 11
David Nettleton David Nettleton
$190
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
John E Lincoln John E Lincoln
$189
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit
Michael Ramcharan Michael Ramcharan
$1,295
Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices
MP3 Download This virtual seminar will address those project management critical tasks within each project phase that must be performed
Charles H. Paul Charles H. Paul
$1,495
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training
MP3 Download The objective of this live training webinar is to develop an understanding
Kelly Thomas Kelly Thomas
$349
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

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