A current trending topic in the cleaning validation world is the issue of chemical analysis for residues during routine manufacture. This instructor-led live webinar will discuss the reasons for this topic, and then move to the use of a visually clean assessment to demonstrate that residues of the drug active are below the acceptance limits. This live training session will focus on the differences between the objectives of a cleaning validation protocol and the objectives of routine monitoring after the cleaning process is validated. It will focus on the traditional use of routine monitoring to demonstrate that that the cleaning process is in a “state of control”, and will then move to a discussion of the use of visual residue limits to demonstrate that residue acceptance criteria are being met. Appropriate methods to establish a “visual residue limit” will be covered.

Learning Benefits:

• Understanding the purposes of a validation protocol and routine monitoring data.
• Learning what “visually clean” means.
• Clarifying what EU Annex 15 and EMA Q&A say about routine monitoring and visual assessment.
• Understanding how to establish Visual Residue Limits.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Reasons why this is a “hot topic”,
EU Annex 15 and EMA Q&A,
Purposes of validation protocols and routine monitoring,
Traditional approach to routine monitoring,
Visual assessment in protocols and routine monitoring,

11:30 AM 10 Minute Break

                Definition of visual residue limits (VRLs),
Establishing a VRL,
VRLs in validation protocols,
VRLs for routine monitoring,
Expected uses of VRLs,

12:30 PMLive Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

• A copy of the presentation slides
• A certificate of training for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Microbiology Personnel
• Quality Control, Quality Assurance, Manufacturing Personnel
• Regulatory Affairs Personnel
• Toxicologists/Pharmacologists
• Senior Management responsible for cleaning validation
• Technical Support, Engineering

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.