Courses

Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry

Dec 04-06 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company

Kelly Thomas

$1,295

Effective Project Communications and Reporting your Progress

Dec 05 This webinar will discuss communications in project management and how organizations that communicate effectively

Charles H. Paul

$299

Project Management for FDA-Regulated Companies in the Postpandemic World: Are You Ready for New Approaches and Methods?

Dec 06 This webinar will provide valuable guidance to regulated companies in development

John E Lincoln

$249

The 6 Most Common Problems in FDA Software Validation and Verification

Dec 06 | Mar 14 This webinar covers the fundamentals of 21 CFR Part 11, software validation

David Nettleton

$287

Technical Writing for professionals in the life sciences

Dec 06-08 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

$1,495

FDA Recalls - Before You Start, and After You Finish

Dec 12-13 this seminar will help you to Understand FDA's recall authority and policy

Kelly Thomas

$1,495

FDA Inspection Seminar

Dec 07-08 This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter

David R. Dills

$1,895

CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture

Dec 07 This Webinar presentation will provide a thorough understanding of the content

Roger Cowan

$1,095

Drug Development: Key to Success from Concept to Commercialization

Dec 07 -08 This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies

Karl M. Nobert

$1,495

The FDA recently released a new draft guidance related to Part 11

Dec 07 The attendee will learn about FDA’s approach to modernizing technology

Carolyn Troiano

$287

US Drug Safety and FDA Inspection Readiness

Dec 07 This training course is designed to give pharmaceutical and biologic companies operating in the US an introduction to the fundamental

Steve Jolley

$895

Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

Dec 11 This webinar will help you understand in detail the new requirements for trial master files. You should attend this webinar if you are responsible for establishing or maintaining a TMF

Carolyn Troiano

$249

Global Regulatory Requirements for Drug Safety & Pharmacovigilance

Dec 12 This training course is designed to give pharmaceutical and biologic companies

Steve Jolley

$995

GMP master class – get it right to avoid compliance issues

Dec 12-13 This training will provide foundation to your GMP training.

Charles H. Paul

$1,295

Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States

Dec 12 The Federal Food, Drug, and Cosmetic Act requires that a manufacturer of a dietary

Travis Austin MacKay

$399

FDA Computer System Validation ( CSV) Training 2 Days Virtual Seminar

Dec 13-14 This Course will explain how to comply with key FDA and international CSV regulations

Carolyn Troiano

$1,295

The EU Clinical Trial Regulation - EU Filings & Registrations

Dec 14 This course covers the requirements for conducting Clinical Studies across the EU

John E Lincoln

$895

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

Jan 10 This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pha

Kelly Thomas

$287

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

Jan 17-18 Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit

Michael Ramcharan

$1,295

21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

Jan 18 This webinar describes exactly what is required for compliance with Part 11

David Nettleton

$299

FDA & OSHA Warehouse Requirements

Jan 18 The webinar will provide attendees with an overview of the FDA’s warehousing regulatory

Karl M. Nobert

$287

FDA Best Audit Practices – get ready for the inspection that is coming

Jan 23 This webinar will begin by discussing and emphasizing the importance of truthfulness

Charles H. Paul

$249

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

Jan 24-25 This eight-hour vendor qualification audit training will help you improve

Kelly Thomas

$1,295

Verification and Validation - Product, Equipment/Process, Software and QMS

Jan 24-25 This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation

John E Lincoln

$1,295

Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

Jan 24-25This virtual seminar will address those project management critical tasks within each project phase that must be performed

Charles H. Paul

$995

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training

Jan 25-26 The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar

Barry A. Friedman

$1,895

510(k) and PMA Submissions Process

Jan 25 This webinar will detail the 510K and PMA processes as well as the EU directives comparing and contrasting those regulations

John E Lincoln

$249

2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

Jan 29-30 This 2 day seminar will go into the specifics of the REACH and RoHS regulations

Kelly Eisenhardt

$1,899

Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations

Jan 30 In this 90-minute accredited training, you will learn the importance of having a good

Danielle DeLucy

$249

GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations

Feb 06 This web presentation presents an overview of FDA’s 3 major regulations

John E Lincoln

$287

Quality Control Laboratory Compliance - cGMPs and GLPs Course - What Regulatory, Compliance & Quality Professionals Need to Know

Feb 08-09 This course will provide an overview of the Regulatory requirements governing QC Labs to ensure compliance with cGMP and GCP

Kelly Thomas

$1,295

Excel Spreadsheets; everything you need to know to pass a Part 11 inspection

Feb 08 This session will make you a better Excel user, saving you time and costs

David Nettleton

$287

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Feb 26-27 The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc

Barry A. Friedman

$1,295

US FDA Labeling Requirements for Medical Devices

Mar 06 In this webinar, including some little known or controlled areas which are subject

John E Lincoln

$269

Biostatistics for the Non-Statistician

MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Elaine Eisenbeisz

$1,295

Establish a Compliant Medical Device Post Market Surveillance and Complaint Handling System

MP3 Download This webinar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles

John E Lincoln

$1,895

Bundles

Test 1

Courses: 4

$1,000