Risk Management for Commissioning and Qualification for Pharmaceutical Industry
More Trainings by this Expert
As long as increase in the regulatory requirements and market needs which causes conflicts between inspectional parties and manufacturers along with limited resources for each party, there must be a harmonized baseline between two parties that both must agree on. Upon achieving this harmonization, this will minimize the efforts that will in turn increase the quality of the product.
Risk-Bases Q&V is considered main pillar to conduct the Q&V plan mainly for the systems that could impact the product Quality (SISPQ) , and this will definitely increase the compliance awareness and decrease the cost as well.
This course is about the technical, compliance and business benefits when conducting the Qualification and Validation (Q&V) for different systems within Pharmaceutical manufacturing facilities, and will also discuss the best Q&V Risk-based approach to minimize the efforts to have your system qualified and validated
Areas Covered in the Session:
Who Will Benefit:
- Introduction to Qualification & Validation and discussion the Validation Lifecycl: This part includes introduction for the Validation including (but not limited to) what, why and when to Validate? As well as addressing the responsibilities for the validation.
Also, this part will discuss the ideal LifecycSle for the systems undergoing the Q&V process so that audience will take good idea where exactly the Risk-Based can play essential role in this cycle.
- Introduction to the Risk based Q&V: During this part, there will be discussion about the risk based methodology to be used when qualification/validation new or existing systems, so that audience will take good idea about the keys of brainstorming to start implementing acceptable risk based approach prior starting the Qualification and Validation activities, upon implementing this successful and logic Risk-Based approach, this will reflect advantageous outcomes on both compliance and business wises as well.
- Case Study Discussion: Case Study will address the actual and live example that could be discussed to show how risk assessment is applied for a specific system , case study may include equipment or utilities.
- Validation scientists manufacturing supervisors
- Equipment Engineers
- Engineering quality assurance specialists
- Professionals from service organizations and vendors who serve pharmaceutical clients
- Regulatory personnel involved in pharmaceutical industries.
- Pharmaceutical Project Manager
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.)