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

Feb 08 This webinar will provide valuable guidance to regulated companies in development and implementation of new Lean Project Management Planning concepts including some Agile principles

John E Lincoln

$299

Microbiological Rapid Method Sterility Testing (RMT) of Short Dated and Other Products

Feb 08 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

$385

Half Day Virtual Seminar on Fundamentals of Toxicology

Feb 08 The course will cover these aspects that are relevant for non-toxicologists involved in drug development.

Dr. Stefano Persiani

$795

Analytical Method Validation, Verification and Transfer

Feb 09-10 In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures

Kelly Thomas

$1,495

The FDA recently released a new draft guidance related to Part 11

Feb 09 The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry.

Carolyn Troiano

$299

Excel Spreadsheets - Develop and Validate to Eliminate 483s

Feb 15 This session will make you a better Excel user, saving you time and costs

David Nettleton

$299

Controlling Human Error in the manufacturing floor

Feb 15 This course offers practical approaches and tools to address human performance issues in GMP related environments

Ginette Collazo

$299

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

Feb 15-17 This eight-hour vendor qualification audit training will help you improve quality in your facility.

Kelly Thomas

$1,498

PK/PD Studies in Drug Discovery and Development

Feb 16 The webinar reviews the general concepts and basic elements of pharmacokinetics, pharmacodynamics, and their correlation

Dr. Stefano Persiani

$199

Data Integrity by Design, Pharma 4.0 and Overcoming DI issues in the Cloud

Mar 07 This webinar will show how exactly is Data Integrity by Design important for achieving Pharma 4.0 and how its implementation can overcome issues of cloud computing.

Carolyn Troiano

$249

Tips and Tricks for Project Management Success

Feb 16 This webinar will outline those tips along with a discussion of the project management tools that apply.

David R. Dills

$299

Writing and Enforcing SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

Feb 22-24 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company activities

Kelly Thomas

$1,495

Part 11 Data Integrity and Cybersecurity – The Latest Developments

Feb 24 The cGMPs have been around for decades. Electronic documentation requirements are newer. Initially there were regulations such as 21 CFR Part 11

John E Lincoln

$495

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

Apr 18 This web presentation presents an overview of FDA’s 3 major regulations – Good Clinical Practices (GCP)

John E Lincoln

$265

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

Feb 23-24 & Mar 15-16 Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit inspection, overview of the European Medicines Agency's Guid

Michael Ramcharan

$6,995

Introduction to Computer System Validation

Feb 27 This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology

Carolyn Troiano

$795

Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

Mar 02-03 In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies

Kelly Thomas

$1,495

Medical Device Change(s) and the 510(k)

Mar 03 This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities

John E Lincoln

$265

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

Mar 07 This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities

Kelly Thomas

$495

The 6 Most Common Problems in FDA Software Validation and Verification

Mar 09 This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation

David Nettleton

$399

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

Mar 15 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

$299

Statistics for Process Control

Mar 14 This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products

Elaine Eisenbeisz

$695

Trial Master File and Clinical Data Management Regulated by FDA

Mar 15 This FDA compliance training will cover in detail the new requirements for trial master files

Carolyn Troiano

$199

2 Day Virtual Seminar on FDA Inspection Essentials in 2022

Mar 15-16 This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol

Danielle DeLucy

$1,295

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

Mar 22-23 The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc

Barry A. Friedman

$1,295

Medical Device Process Validation Training for Professionals

Mar 22 This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971

John E Lincoln

$265

Project Management Bootcamp

March 22- 23 This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly

Charles H. Paul

$1,495

How to write SOP's that Avoid Human Error

Mar 28 This Webinar will discuss the primary cause of quality and production losses in many industries

Ginette Collazo

$199

Building the Project Charter, Project Scope Statement, and the Priority Matrix

Apr 13 This webinar will explain the role of each document in the project management process and their importance

Charles H. Paul

$299

US FDA Labeling Requirements for Medical Devices

Mar 22 in This webinar, including some little known or controlled areas which are subject to regulatory scruinty

John E Lincoln

$265

All About Data Integrity by Design

April 13-14 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

Carolyn Troiano

$1,295

Blockchain Innovations that Connect and Protect the Supply Chain

May 02 This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain

John E Lincoln

$265

Computer System Validation for Cloud and COTS Applications–Live, Online Training

May 03-05 The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Carolyn Troiano

$1,495

The Project Management Plan

June 06 This webinar will introduce the concept of planning and how it is conducted. During the webinar

Charles H. Paul

$299

Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity

June 07 This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority

John E Lincoln

$265

Determining and Managing your Project Risk – The Risk Analysis

Aug 03 This webinar will discuss project risk – how to identify it, how to quantify it, how to mitigate it, and how to prevent it from being realized

Charles H. Paul

$299