Browse products
search
EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete
MP3 Download This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share le
- Course
- By Kelly Thomas
2 Day Virtual Seminar on FDA Inspection Essentials in 2022
MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol
- Course
- By Danielle DeLucy
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
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
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 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
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
- Course
- By Kelly Thomas
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
- Course
- By Kelly Thomas
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
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
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) Training
This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality
- Course
- By Elaine Eisenbeisz
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
The European PSMF
MP3 Download This course teaches you with evolution of the PSMF and the legislation concerning it for the EU, sections of the PSMF, annexes of the PSMF
- Course
- By Graeme Ladds