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
2024 Human Error Prevention & GMP Training Course - New
MP3 Download this training would provide tools that can be implemented and used after this event.
- Course
- By Ginette Collazo
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
3 Hrs Virtual Webinar on Aseptic Processing and Validation
MP3 Download This course will provide an overview of requirements for aseptic and bulk manufacturing operations, including facility design and contamination
- Course
- By Kelly Thomas
3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)
MP3 Download This webinar will review the regulatory requirements for investigating an OOS Investigation.
- Course
- By Danielle DeLucy
3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC
MP3 Download This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software
- Course
- By Jose Mora
6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada
On Demand Webinar Duration 360 minutes
- Course
- By Peggy J. Berry
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
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
Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
MP3 Download this course we will review how quality systems helps in defining requirements for cleanrooms
- Course
- By Danielle DeLucy
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
Clinical Data Management Training
MP3 Download Duration 2 Day
- Course
- By Elaine Eisenbeisz
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
Current regulatory thinking on Data Integrity in 2020
MP3 Download Duration 2 Days
- 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
Efficient Batch Record Review and Product Release Course
MP3 Download Duration 240 Minutes
- Course
- By Danielle DeLucy
FDA Inspection Seminar
May 06-07 This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter
- Course
- By Kelly Thomas
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
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
Global Regulatory Requirements for Drug Safety & Pharmacovigilance
MP3 Download This training course is designed to give pharmaceutical and biologic companies
- Course
- By Steve Jolley
Human Error Tool Box: A practical aproach to human error
On Demand Webinar Duration 180 minutes
- Course
- By Ginette Collazo
Introduction to Computer System Validation
MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology
- Course
- By Carolyn Troiano
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
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
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
Post-Market Activities in the EU-MDR — A Detailed Analysis
MP3 Download Medical device training will review the new EU-MDR requirements governing Post Market Activities and discuss quality system approaches
- 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 in the Life Sciences
On Demand Webinar Duration 360 minutes
- 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
Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)
MP3 Download In this two day workshop conference you will learn the requirements and expectation
- 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
SOP Writing, Training and Compliance for the Pharmaceutical Industry
On Demand Webinar Duration 180 minutes
- Course
- By Michael Esposito
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
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
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
Understanding the FDA: How to avoid the most recent observations
MP3 Download - Duration 240 Minutes
- Course
- By Carl Patterson
Understanding the Process Validation Life Cycle
MP3 Download Duration 90 Minutes
- Course
- By Danielle DeLucy
Verification and Validation - Product, Equipment/Process, Software and QMS
May 21-22 This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation
- 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
cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA
MP3 Download This webinar will cover the key areas of how ICH Q7 was established, it's goals and object
- Course
- By Kelly Thomas