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USA Seminars


Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Mar 22-23 & Apr 24-26 The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc
Barry A. Friedman Barry A. Friedman
$1,295
Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)
Mar 22-23 This seminar will describe the requirements, the dos and don’ts commonly performed by laboratories, the writing of a Standard Operating Procedure
John C. Fetzer John C. Fetzer
$995
All About Data Integrity by Design
April 13-14 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
$895
Writing and Enforcing SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
Apr – 17-19 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company activities
Kelly Thomas Kelly Thomas
$1,295
Computer System Validation ( CSV) 3 Day Seminar
Apr 17-19 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
$1,295
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Apr 24-26 This eight-hour vendor qualification audit training will help you improve quality in your facility.
Kelly Thomas Kelly Thomas
$1,295
Computer System Validation for Cloud and COTS Applications–Live, Online Training
May 03-05 The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry
Carolyn Troiano Carolyn Troiano
$1,295
Biostatistics for the Non-Statistician
May 08-09 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
$1,295
Basic GMP Training for the QC Laboratory
May 16-17 This course will provide participants with an understanding of how to effectively handle out-of-specification
Kelly Thomas Kelly Thomas
$1,295
2 Day Virtual Seminar on FDA Inspection Essentials in 2023
MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol
Danielle DeLucy Danielle DeLucy
$1,295
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
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit inspection, overview of the European Medicines Agency's Guid
Michael Ramcharan Michael Ramcharan
$6,995
Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA
MP3 Download we will discuss what is needed to prepare for an FDA inspection of computer systems and data used in support of clinical trials.
Carolyn Troiano Carolyn Troiano
$1,495
GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries
MP3 Download GMP Auditing for the Pharmaceutical Industry
Kelly Thomas Kelly Thomas
$1,495
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
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 flawlessly for effective
Charles H. Paul Charles H. Paul
$4,665
Analytical Method Validation, Verification and Transfer
MP3 Download In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures
Kelly Thomas Kelly Thomas
$1,495
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
MP3 Download 2 Day Virtual Seminar
Karl M. Nobert Karl M. Nobert
$1,395
Pharmaceutical Document Management Training Course - A Global Regulatory Approach
MP3 Download This course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries
Kelly Thomas Kelly Thomas
$1,495
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
CROs (Clinical Research Organizations) - Identification, Selection, and Management for Maximum Results & Value
MP3 Download This course will provide the attendees with all the specific methodology and management techniques to successfully outsource pharmaceutical programs
Kelly Thomas Kelly Thomas
$1,495
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
Drug Development: Key to Success from Concept to Commercialization
MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies who would like an understanding
Karl M. Nobert Karl M. Nobert
$1,295
Statistical Process Control (SPC) One Day Masterclass
MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products
Elaine Eisenbeisz Elaine Eisenbeisz
$996
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 flawlessly for effective
Charles H. Paul Charles H. Paul
€1.495
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, provide case studies and share lessons learned so your
Kelly Eisenhardt Kelly Eisenhardt
$1,899
FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar
MP3 Download This Course will explain 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
$1,895
Computer System Validation for Cloud and COTS Applications
May 03-05 The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry
Carolyn Troiano Carolyn Troiano
$1,495
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 is to explore raw materials and their requirements – issues and solutions.
Barry A. Friedman Barry A. Friedman
$1,496
Technical Writing for professionals in the life sciences
MP3 Download 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
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
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
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
$1,495
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
Computer System Validation Professional Certification Program 3 Days
MP3 Download The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles
Carolyn Troiano Carolyn Troiano
$1,295