Description

Description:

In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. This webinar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant.

Course Objective:

The objective of this course is to help attendees understand  that the cost of non-compliance is more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility?

Course Outline:

•    Requirements and approaches for Analytical Instrument Qualification

•    Going through the qualification phases

•    Testing and deviation handling

•    Retrospective qualification and Requalification

•    Equipment Maintenance and Change control

•    Type and extend of qualification for USP Instrument Categories

•    Requirements and approaches for Laboratory Computer Systems

•    Validation of Laboratory Computer systems

•    Validation and Use of Excel in the QC Laboratory

•    Periodic review and revalidation of chromatographic data system

•    Handling raw data and other laboratory records

•    Ensuring Integrity and Security of Laboratory (Raw) data

•    Auditing Laboratory Computer Systems and records for FDA Compliance

Target Audience:

•    Laboratory managers, supervisors and analysts

•    IT managers and staff

•    Consultants

•    Laboratory suppliers of material, equipment and services

•    Senior quality managers

•    Quality professionals

•    Regulatory professionals

•    Compliance professionals

•    Production supervisors

•    Validation engineers

•    Manufacturing engineers

•    Production engineers

•    Design engineers

•    Process owners

•    Quality engineers

•    Quality auditors

Instructor Profile:

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing.  Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.  In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.  Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

 

For More Details: FDA Online Training.

Email:david@grcts.com | Tel:+1-248-233-2049 | Web:www.grcts.com. 

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