Courses

FDA Regulations for Tobacco & Tobacco-Related Products – Computer System Validation (CSV), 21 CFR Part 11 (electronic records/signatures), Data Integrity & Compliance

Jul 15 You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA

Carolyn Troiano

$199

Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product

July 16-17 In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations

Karl M. Nobert

$1,495

Supplier and Contract Manufacturer Management

July 21-22 | Sep 24-25 This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification

Kelly Thomas

$1,295

Global Regulatory Requirements for Drug Safety & Pharmacovigilance

July 24 This training course is designed to give pharmaceutical and biologic companies

Steve Jolley

$995

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

July 25-26 | Sep 22-23 The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar

Barry A. Friedman

$1,495

Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

July 28-29 | Sep 16-17 This seminar 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

Technical Writing for professionals in the life sciences

July 28-30 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

$1,895

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

Kelly Thomas

$1,495

cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

29 July This webinar will cover the key areas of how ICH Q7 was established, it's goals and object

Kelly Thomas

$695

AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework

Jul 30 The use of Generitive AI in the Drug discovery and Development Process. The US FDA's encouragement of AI technology in pharma development and clinicals - their risk-based framework.

John E Lincoln

$199

Software Verification and Validation - The 10 Must Have Documents

Aug 05 The tougher FDA expects a company to develop and run a formal software V&V plan . The model presented here satisfies their requirements for all software/firmware/PLC V&V.

John E Lincoln

$199

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

Aug 05-07 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company

Kelly Thomas

$1,895

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

David Nettleton

$1,895

21 CFR Part 11 Compliance for SaaS/Cloud Application

David Nettleton

$1,895

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Aug 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.

David Nettleton

$1,895

Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)

Aug 07 In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle

Carolyn Troiano

$199

Computer System Validation ( CSV) 3 Day Seminar

Aug 12-14 3 day CSV course will teach you how to comply with key FDA and international CSV

Carolyn Troiano

$1,895

The 6 Most Common Problems in FDA Software Validation and Verification

Aug 14 This webinar covers the fundamentals of 21 CFR Part 11, software validation

David Nettleton

$190

Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training

Aug 19 The objective of this live training webinar is to develop an understanding

Kelly Thomas

$299

The EU Clinical Trial Regulation - EU Filings & Registrations

Aug 20 This course covers the requirements for conducting Clinical Studies across the EU

John E Lincoln

$995

Risk Management for AI in Medical Devices – FDA’s TPLC Management Draft Guidance

20 Aug This webinar will cover the FDA’s total product life cycle approach and FDA’s roles and responsibilities in regulating medical devices throughout their lifecycle. The US FDA has long promoted a Risk-Based Total Product Life Cycle (TPLC)

John E Lincoln

$199

GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

Aug 21-22 GMP Auditing for the Pharmaceutical Industry

Kelly Thomas

$1,295

Drug, Device and Combination Product Development

Aug 25 Combination products are subject to a combination of CGMPs to form an "Operating System". This greatly increases compliance to the Combo Products CFMPs, 21 CFR 4. And recent problems have compounded supply chain issues.

John E Lincoln

$199

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

Kelly Thomas

$1,895

FDA Inspection Seminar

Sep 03 - 04 This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter

Kelly Thomas

$1,450

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

July 28-29 | Sep 08-09 This 2 day seminar will go into the specifics of the REACH and RoHS regulations

Kelly Eisenhardt

$1,895

Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements

Sep 09-10 In this accredited training, we will identify and discuss Master Batch Records (MBR), regulatory requirements, and key steps for issuance, batch record review, reconciliation, and final QA disposition

Kelly Thomas

$1,450

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

Sep 11-12 This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation

John E Lincoln

$1,295

Biostatistics for the Non-Statistician

Sep 16-18 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Elaine Eisenbeisz

$1,895

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Sep 23 The seminar will cover what you need to do to prepare for an FDA audit, and also the importance and steps required to be certain you have audited all vendors of regulated systems appropriately.

Carolyn Troiano

$499

Analytical Methods Validation for FDA Compliance

Oct 07-09 In this course, general guideline for the determination of the analytical

Kelly Thomas

$1,895

Regulatory Compliance for Dietary Supplements in the US, EU and Canada

Oct 21-23 This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada

Travis Austin MacKay

$1,895

Quality Control Laboratory Compliance - cGMPs and GLPs

Oct 21-22 This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions

Kelly Thomas

$1,450

Master Validation Plan - The Unwritten Requirements

MP3 Download What is the FDA definition of "risk based" and how is it documented in the V&V test report. Additional recommended supporting systems / documentation

John E Lincoln

$499

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

describes exactly what is required for compliance with Part 11

David Nettleton

$190

Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

MP3 Download This Course will explain how to comply with key FDA and international CSV regulations

Carolyn Troiano

$1,495

Bundles

GMP Laboratory Control Professionals Certification Program

WCS 6-part GMP Laboratory Control Certification program provides the key principles and tools required to become a GMP Laboratory Control Professional.

Courses: 6

$1,295

Sterilization Professionals Certification Program

WCS 5-Part Sterilization Professional Certification program provides detailed training on the key principals and tools required to become a Sterilization Professional

Courses: 5

$1,495

Good Manufacturing Practices (GMP) Certification Course

Online GMP Training courses

Courses: 4

$1,495

FDA Inspection Readiness Certification Program

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations.

Courses: 7

$1,495

US Dietary Supplements Certification

US Dietary Supplements Virtual Course Online

Courses: 3

$3,995

Lyophilization Basics for Pharmaceuticals

8 hrs Instructor-led Virtual Seminar -Lyophilization Pharmaceutical Course

Courses: 1

$1,295

Pharmacovigilance Certification

Pharmacovigilance Online Courses & Certifications

Courses: 2

$3,995