ComplianceOnline

This 3-hr FDA audit & Inspection training will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution.

This Process Validation training for biological products will provide valuable assistance on how to integrate the PV work into your development program using QbD in light of the issuance of new regulations by the FDA.

In this 3-hr training on Facility Management you will learn how to develop thorough maintenance documents that are clear and confusion-free nd you will discover how to perform and document corrective work in a manner that eliminates ambiguity.

Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.

This webinar on change control will discuss how to interpret the cGMP regulations with respect to the present climate of requirements

This 90-minute Equipment Qualification training will show how pharmaceutical manufacturers can plan and execute a retrospective/prospective qualification plan for their equipments.

In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms.

This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures.

This webinar will cover a step-by-step process to construct and submit the European Drug Master File (EDMF), recordkeeping requirements and manufacturer responsibilities.

This DDMAC Compliance training will cover regulations, their application and enforcement activities as they relate to FDA’s Division of Drug Marketing, Advertising and Communications.