Seminar Overview

Although cleaning validation is universally addressed in regulatory guidances/regulations and fundamental concepts have been widely published, certain areas of cleaning are not truly science-based or clearly understood.  This presentation addresses problematic issues in cleaning validation raised by workers in the field.

Topics identified in this seminar are primarily technical issues that should be addressed prior to executing cleaning validation.  Example topics include physical and chemical properties of the residue as a basis for cleaning, stability of the residue in developing analytical methods, and non-uniform contamination.  This suggests the need for enhanced technical support and integration of the various stages of the validation lifecycle.  Other topics of concern are related to compliance including manual cleaning and training for swab sampling.  All of these issues have the potential to greatly impact the integrity of a cleaning program.

Leaning Objectives

During this webinar, participants will be able to:

• Identify significant and commonly encountered issues in cleaning validation programs.
• Suggest strategies and approaches to address these problems.

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.