
Pharmaceutical Quality Management - Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible
Charles H Paul
90 Min
Product Id: 706825
This instructor-led live webinar will discuss the established approach of Pharmaceutical Quality Management as it relates to the relationship between risk management and the pharmaceutical regulations that govern the business.

Effective Systems for Change Control in the Pharmaceutical Industry
David L Chesney
90 Min
Product Id: 705002
This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

Documentation and Medical Writing Training for Pharmaceutical Regulatory Affairs Professionals
7 Hrs
Product Id: 706839


Drug Development, Clinical Trials, Clinical Research GCP - Training Bundle for Quality Professionals
13 Hrs
Product Id: 706837


Performing Effective Management Review of the Quality System
David L Chesney
90 Min
Product Id: 704933
This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.

Project Management for FDA-Regulated Companies
John E Lincoln
60 Min
Product Id: 701758
This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

Reviewing Drug Product Batch Records
Mark Powell
60 Min
Product Id: 706287
Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.

FDA's Ambitious Regulation of Social Media
Casper Uldriks
60 Min
Product Id: 703853
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

Troubleshooting Dissolution Methods for Solid Oral Dosage Forms
Mark Powell
60 Min
Product Id: 706599
The root cause of variable or inconsistent data from compendial dissolution tests can be difficult to identify. Formulation, equipment, operator error and incorrect calculation may be factors. This webinar presents a systematic, logical approach to investigating anomalous dissolution results.

How to Prepare a Standard Operating Procedure (SOP)?
Dr. Afsaneh Motamed Khorasani
60 Min
Product Id: 705131
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
Travis Austin MacKay
120 Min
Product Id: 702317
This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action.

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
Kelly Thomas
90 Min
Product Id: 702540
This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.

Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates
Travis Austin MacKay
90 Min
Product Id: 702154
This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.

Good Documentation Guideline (Chapter <1029> USP)
Dr. Afsaneh Motamed Khorasani
60 Min
Product Id: 705130
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
Ginette M Collazo
60 Min
Product Id: 704210
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.

Basic Cleanroom Technology, Operation and Contamination Control in a Nutshell
Charity Ogunsanya
90 Min
Product Id: 706142
Attend this webinar to understand the Clean Room regulations, design, classification, sources and types of particles. Learn how to create a common ground between these varying regulations and requirements. It will discuss the types of micro-organisms, routine monitoring processes, and typical mitigation steps to effective contamination control.

Annual Current Good Manufacturing Practices (cGMP) Training
Kelly Thomas
60 Min
Product Id: 705422
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

Investigation of Out-of-Specification Test Results
Paul Larocque
90 Min
Product Id: 706638
Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.