2020 - Streamlined Approach with Requalification for Pharmaceutical Systems (Qualified Equipment and System Management in Pharmaceutical Industry)

Overview:
This training session gives detailed information (in addition to case study) for how to determine what are the pharmaceutical systems/Equipment that must be subjected to periodic requalification activities, and also to ensure that each system is still under control and within validated/qualified state.
Furthermore, the new streamlined approach for Impact-and-Risk-Assessment will be discussed make sure that the system is subjected to requalification intervals according to regulatory requirements as well as thumb of industry.
Why you should Attend:There are a lot of requalification activities and other periodic reviews for the pharmaceutical systems and equipment, which unfortunately could be excessive works and may take unnecessary efforts, Consequently, this process must depend on how much these systems are critical or have direct impact on the patient safety.
So, this course will give a guidance for how to ideally build a robust requalification system to ensure that compliance is achieved in ideal way, that in turn will be advantageous for saving cost, effort and time required for requalification and periodic reviews activities. Also, will make sure that all routine activities (i.e. maintenance, calibration) are applied effectively
Areas Covered in the Session:
Introduction to Systems and Equipment Lifecycle
This part includes a brief about Qualification activities that are applied with any system/Equipment starting from setting the specifications until system working and finally until retirement phase .
Related programs associated with Qualified Equipment/ Systems
During this part, there will be a discussion about the programs that are applied to Pharmaceutical Equipment and Systems, where these programs will be embedded with current Total Quality Management System (TQM). Also, within this part, an overview for requalification program will be discussed for how these activities are together interlinked and cross-functioned for the sake of optimization the requalification activities (including, Change Control, Safety, Procedures, Maintenance, Calibration, Requalification..etc..)
Requalification Rationality Assessment (Case Study)
This case study will illustrate the traditional and new approach for implementing the requalification study
Who Will Benefit:
Validation and Qualification Manager/Designee/ or Specialist
Engineering Manager/Designee/ or Specialist
Quality Assurance Manager/Designee/ or Specialist
Regulatory Affair Manager/Designee/ or Specialist
Compliance Department Manager/Designee/ or Specialist
Regulatory personnel involved in pharmaceutical industries
Speaker Profile
Majdi is dedicated and results-driven Q&V expert with a highly successful background with Pharmaceutical companies in both project and operation fields to achieve the best possible performance through the creation and execution of successful and creative Q&V strategies.
He worked with different departments within Pharmaceutical Engineering Fields, During his experience for the last 16 years, he had implemented different GxP concepts including: Engineering Designs; Setup Project Policy & Engineering Quality systems; Implementation of Equipment Qualification and Calibration for: Production Systems, Facilities Management and Infrastructures ,utilities for both sterile/ non-sterile facilities as well as API’s facilities ; along with his experience for preparation and attendance different inspections by local/international authorities (FDA,EU and Local …..And others.)
Event link: https://www.compliance4all.com/webinar/--502875LIV...
Contact Info
Compliance4all
Email: support-AT-compliance4All.com
Phone: +1-800-447-9407
Website: https://www.compliance4all.com/