Seminar Overview

Current knowledge and approaches to cleaning validation consistent with current regulatory documents and expectations will be discussed.  Presentation will progress from general basic overview information to technical aspects of cleaning process development, equipment, and analytical methods; actual PQ cleaning validation, and maintaining the validated state.  Key elements of cleaning validation programs will be discussed.  In brief, this presentation will describe the “how, what, and why” of cleaning and cleaning validation.  Scientific and technical bases for problem elements in cleaning and cleaning validation will be emphasized.

Leaning Objectives

During this webinar, participants will be able to:

• Identify the significant components of successful cleaning validation programs. 
• Discuss key aspects of cleaning validation according to the lifecycle approach, fundamental cleaning chemistry and engineering principles, technical aspects of residues, equipment considerations, analytical methods, cleaning process development, performance, and post-PQ monitoring. 
• Suggest important areas of focus for successful cleaning and cleaning validation programs.

Who Should Attend

Personnel involved in performance or support of cleaning and cleaning validation:  Validation, Engineering, Manufacturing, QA / QC, Analytical, and Documentation personnel.

Author

Paul L. Pluta, PhD
University of Illinois – Chicago
Institute of Validation Technology / Advanstar Communications

Author Bio

Paul L. Pluta, PhD, is a pharmaceutical scientist with extensive industrial development, manufacturing, and management experience.  He has been involved in nearly all phases of product development and manufacturing for small molecule dosage forms including R&D formulation and process development, dissolution, stability, specifications, regulatory, quality assurance / control, compliance, scale-up, technology transfer, technical support, and validation / qualification.  His validation experience includes manufacturing process validation, cleaning validation, and qualification of associated support systems.

Dr. Pluta is also Adjunct Associate Professor at the University of Illinois-Chicago College of Pharmacy.  He is also editor-in-chief of the Journal of Validation Technology and the Journal of GXP Compliance, both publications of the Institute of Validation Technology / Advanstar Communications.  Dr. Pluta has recently edited Cleaning and Cleaning Validation, published by PDA and DHI Publishing.