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FDA’s Import Alerts
May 18 This webinar will provide attendees with background about FDA Import Alerts, examine why they are issues
Karl M. Nobert Karl M. Nobert
$299
Computer System Validation ( CSV) 3 Day Virtual Seminar
May 18-20 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
$2,950
Annual Current Good Manufacturing Practices (cGMP) Training
May 23 This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement
Kelly Thomas Kelly Thomas
$229
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
May 24 This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted
David Nettleton David Nettleton
$199
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
May 24-25 , 2022 The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc
Barry A. Friedman Barry A. Friedman
$1,593
Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing
June 01 Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing
Carolyn Troiano Carolyn Troiano
$249
Risk Management of Raw Materials in a GMP Environment
June 02 | Aug 09 The live training webinar will explore the number of lots required to be tested before reduced testing might occur
Barry A. Friedman Barry A. Friedman
$385
FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges
June 2-3 , 2022 In this two day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.
Carolyn Troiano Carolyn Troiano
$1,295
GMPs for MICROBIOLOGISTS — The Manufacturing Environment
June 08 The objective of this live, interactive Executive Conference Corp (ECC) webinar is to obtain an enhanced understanding
Barry A. Friedman Barry A. Friedman
$385
GMPs for the Life Sciences – 12-Hour Virtual Seminar
June 9-10 This training will provide foundation to your GMP training.
Charles H. Paul Charles H. Paul
$1,295
Lyophilization Basics for Pharmaceuticals: Scale-Up, Validation, Deviations
June 07 This course will provide an overview of the process, and suggest approaches that may be considered
Lisa Hardwick Thompson Lisa Hardwick Thompson
$299
Human Error Solutions: How we reduced 60% of human errors in less than a year, a Case
June 07 Join this session by expert speaker Ginette Collazo, where she will discuss how by redesigning the training function and by focusing on the expected result
Ginette Collazo Ginette Collazo
$249
Project Management for Non-Project Managers
June 07-08 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
$995
Non-conforming Materials in a Medical Device Company – dealing with in-house to field issues
June 09 Join industry expert Susanne Manz to learn online the essentials of dealing with non-conforming material and performing effective failure
Susanne Manz Susanne Manz
$399
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
June 13-14 This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada and discuss how to verify that products
Travis Austin MacKay Travis Austin MacKay
$1,495
Assessment of Drug-drug Interactions in Drug Development
June 13 The topics that will be discussed during the webinar include the investigation of CYP enzyme- and transporter-mediated drug interactions
Dr. Stefano Persiani Dr. Stefano Persiani
$199
Device Changes, FDA Changes, and the 510(k)
June 15 In this webinar you will learn What approaches are required for product changes; for process changes
John E Lincoln John E Lincoln
$199
Biostatistics for the Non-Statistician
June 15-17 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
$1,495
Excel Spreadsheets - Develop and Validate to Eliminate 483s
June 16 This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$199
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
June 16-17 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
$1,495
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
June 23-24 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
Lyophilization Basics for Pharmaceuticals: History, Scientific Principles, Cycles and Formulations
June 30, Aug 25 To learn the how and why for formulating and designing lyophilization cycles for drugs that will benefit from the freeze-drying process
Lisa Hardwick Thompson Lisa Hardwick Thompson
$595
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
June 22-23 , 2022 2 Day Virtual Seminar
Karl M. Nobert Karl M. Nobert
$1,495
Statistics for Process Control
June 30, This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products
Elaine Eisenbeisz Elaine Eisenbeisz
€795
Microbiological Rapid Method Sterility Testing (RMT) of Short Dated and Other Products
July 05 The objective of this live, interactive training Executive Conference Corp webinar is to obtain an enhanced understanding of the new USP General Information Chapter
Barry A. Friedman Barry A. Friedman
$385
The Most Common Problems in FDA Software Validation & Verification
July 06 This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models
John E Lincoln John E Lincoln
$199
Drug Development: Key to Success from Concept to Commercialization
July 07-08 This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies who would like an understanding
Karl M. Nobert Karl M. Nobert
$995
FDA Recalls - Before You Start, and After You Finish
July 06-07 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
$2,995
Technical Writing for professionals in the life sciences
July 13-15 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
2 Day Virtual Seminar on FDA Inspection Essentials in 2022
July 14-15 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
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
July 20-21 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
$1,899
Extractables & Leachable in Drug Development
July 19 In this webinar expert speaker Stefano Persiani will focus on the basics of an effective extractables and leachables program
Dr. Stefano Persiani Dr. Stefano Persiani
$199
Computer System Validation Professional Certification Program 3 Days
July 21-13 , 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
EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete
July 21-22 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
Kelly Thomas Kelly Thomas
$755
Basic GMP Training for the QC Laboratory
July 27-28 This course will provide participants with an understanding of how to effectively handle out-of-specification
Kelly Thomas Kelly Thomas
$1,295
The Veterinary Drug Approval Process and FDA Regulatory Oversight
August 04-05 This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government
Karl M. Nobert Karl M. Nobert
$2,995