Equipment Requalification: What and When it is Really Required?

Why Should You Attend:

Knowing requalification is part of your qualification program is a first good step. The next steps include determining when it should be performed, finding ways to ensure it gets performed, figuring out what aspects need to be requalified, and above all, making sure the decisions you make are compliant with regulations and industry best practices. If this seems to be a daunting task and you’re not sure where to start, you will certainly benefit from attending this webinar on equipment requalification.

In a simple-to-understand, yet detailed training session, the instructor will present a systematic approach for incorporating requalification into your equipment qualification program.

Areas Covered in the Webinar:

• Sustainable approach for addressing requalification
• The importance of traceability and clarity in demonstrating compliance
• How change control and other quality programs feed into the equipment qualification program
• Audit forms/checklists and other equipment requalification documents
• Identification of events that could trigger requalification
• Using a risk-based evaluation to determine the extent of the requalification
• Common pitfalls to avoid when requalifying equipment

Who Will Benefit:

• Internal Auditors
• Regulators
• Compliance Officers
• QC Managers
• QA Managers
• Quality and Validation Department Staff
• Compliance Consultants
• Senior Management

Instructor Profile:

Jennifer Medlar, has over 10 years’ experience in the areas of quality assurance, quality control, process development, and validation in both industry and consulting roles. She has experience in the biopharmaceutical, pharmaceutical, medical device, cosmetic, dietary supplement, feed additives and industrial product industries.

Prior to Advanced Biomedical Consulting (ABC), LLC, Jennifer worked for Belcher Pharmaceuticals, a contract and proprietary solid and liquid oral dose pharmaceutical manufacturing facility, in increasing roles of responsibility from Quality Control Analyst to Quality Group Leader. Prior to Belcher Pharmaceuticals, Jennifer worked at TSE Industries, as a Chemist and has also worked for the Department of Agriculture as a Quality Control Chemist. In addition, Jennifer has experience in the education field. She taught analytical chemistry at the University of South Florida and has worked for Link-Systems International as a Project Coordinator for the development of online content that accompanies chemistry and other science text books.

Topic Background:

The process of setting up equipment in a facility that manufactures FDA regulated products includes ensuring that the equipment will safely and consistently work as intended. To cover all of the necessary criteria, equipment qualifications are typically organized by separating the protocol into three sections, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. However, the job doesn’t end when the initial qualification is done. There are a number of events that result in the need for a requalification and making sure requalification is performed when they occur can be just as important as the initial qualification.

Follow us :