Effective cleaning validation procedures for analytical equipment

[Adam Fleming]

Regulatory agencies the world over have put in place stringent requirements for ensuring that cleaning validation procedures for analytical equipment are effective. Even if putting these practices in place involves expense and effort, it is worth the trouble, because the cost of noncompliance is much, much higher than that of compliance.

Noncompliance with regulations for cleaning validation procedures for analytical equipment has a serious consequence: Regulatory bodies such as the FDA could take highly punitive actions against companies that show noncompliance, leading to huge money penalties and huge loss of reputation and the customer base.

Taking the rights steps for ensuring effective cleaning validation procedures for analytical equipment

In order to ensure that cleaning validation procedures for analytical equipment is effective; manufacturing companies need to know how to take steps that ensure cleaning validation regulatory compliance, along with risk-based, reasonable and informed decision making and activity planning.

Individuals in management, who are involved in the development of cleaning procedures, cleaning validation programs and plans, need to have a thorough understanding of the FDA perspectives on cleaning validation and areas of concern during regulatory inspections. They need a sound grasp of the elementary principles of a cleaning validation program.

A webinar to make cleaning validation procedures for analytical equipment effective

The skills needed for being able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations will be the core of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this session, Joy McElroy, Principal Consultant at Maynard Consulting Company, who brings over 12 years of experience as a consultant, and over 20 years of total experience in the pharmaceutical and biotech industries and has extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, will be the speaker.

In order to gain full understanding of effective cleaning validation procedures for analytical equipment; just visit http://www.compliance4all.com/control/w_product/~product_id=501118?... to register for this highly valuable learning session.

Building bulletproof solutions

At this webinar, Joy will impart learning on the expectations different global agencies have of analytical equipment qualification. She will offer an understanding of how to develop a sound process validation program with which to develop and implement bulletproof solutions that are accepted, effective, and efficient.

This session on effective cleaning validation procedures for analytical equipment will also offer case study analyses, through which the best practices for providing thoughts and ideas to develop or improve the performance of participants’ current system will be examined.

Additional learning on instrument qualification and system validation processes

Another benefit the case studies presented at this webinar on effective cleaning validation procedures for analytical equipment is that they will help participants to explore how the management practices of their analytical equipment qualification/validation and process validation programs can either foster or impede their legal liability and the legal issues that arise from nonconformance with regulators and auditors. Learning on the instrument qualification and system validation processes will be another part of this webinar.

This webinar on effective cleaning validation procedures for analytical equipment will be immensely useful for professionals in the area of cleaning validation for analytical equipment, such as Senior Quality Managers, Quality professionals, Production supervisors, Validation engineers, Process owners, Quality engineers, and Quality auditors.

Joy will cover the following areas at this webinar:

o  Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product

o  Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections

o  Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations

o  Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies.