2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
May 14-15 This 2 day seminar will go into the specifics of the REACH and RoHS regulations
- Course
- By Kelly Eisenhardt
21 CFR Part 11 Compliance for SaaS/Cloud Application
Aug 06-07 This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors
- Course
- By David Nettleton
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit
- Course
- By Michael Ramcharan
All About Data Integrity by Design
MP3 Download 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
- Course
- By Carolyn Troiano
Analytical Methods Validation for FDA Compliance
June 03-05 In this course, general guideline for the determination of the analytical
- Course
- By Kelly Thomas
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
- Course
- By Barry A. Friedman
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Aug 26-28 This eight-hour vendor qualification audit training will help you improve
- Course
- By Kelly Thomas
Basic GMP Training for the QC Laboratory
MP3 Download This course will provide participants with an understanding of how to effectively handle out-of-specification
- Course
- By Kelly Thomas
Biostatistics for the Non-Statistician
May 19-20 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
- Course
- By Elaine Eisenbeisz
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
- Course
- By Karl M. Nobert
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
- Course
- By Carolyn Troiano
Computer System Validation for Cloud and COTS Applications–Live, Online Training
MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry
- Course
- By Carolyn Troiano
Drug Development: Key to Success from Concept to Commercialization
MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies
- Course
- By Karl M. Nobert
FDA Recalls - Before You Start, and After You Finish
July 29-30 This seminar will help you to Understand FDA's recall authority and policy
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- By Kelly Thomas
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.
- Course
- By Karl M. Nobert
GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries
Apr 23-24 GMP Auditing for the Pharmaceutical Industry
- Course
- By Kelly Thomas
Global Regulatory Requirements for Drug Safety & Pharmacovigilance
MP3 Download This training course is designed to give pharmaceutical and biologic companies
- Course
- By Steve Jolley
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
- Course
- By Lisa Hardwick Thompson
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
May 22-23 This seminar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles
- Course
- By John E Lincoln
Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents
MP3 Download this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.
- Course
- By Kelly Thomas
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
- Course
- By Kelly Thomas
Preparing for and Managing Successful FDA Inspections
MP3 Download This seminar, you will learn how to properly alert key members that an investigator
- Course
- By Danielle DeLucy
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
MP3 Download The lifecycle concept, new to these Guidance, link product and process development, qualification
- Course
- By Barry A. Friedman
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
- Course
- By Charles H. Paul
Quality Control Laboratory Compliance - cGMPs and GLPs
May 20-21 This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions
- Course
- By Kelly Thomas
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
- Course
- By Barry A. Friedman
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
Apr 06-07 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.
- Course
- By David Nettleton
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
June 10-12 This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada
- Course
- By Travis Austin MacKay
Risk-based Computer System Validation; Reduce Costs and Avoid 483s
Aug 06-07 This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors
- Course
- By David Nettleton
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
- Course
- By Elaine Eisenbeisz
Supplier and Contract Manufacturer Management
May 20-21 This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification
- Course
- By Kelly Thomas
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
- Course
- By Charles H. Paul
The EU Clinical Trial Regulation - EU Filings & Registrations
Apr 22 This course covers the requirements for conducting Clinical Studies across the EU
- Course
- By John E Lincoln
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
- Course
- By Karl M. Nobert
Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry
Apr 22 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company
- Course
- By Kelly Thomas
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
- Course
- By John C. Fetzer