This 2-day Online Training brings together well-experienced experts to discuss the latest expectations and best practices for effective and efficient Quality Oversight processes and how to get there. This will support you turning your company’s quality excellence goals into reality.
Background
The US Food and Drug Administration FDA frequently criticises pharmaceutical companies for not having sufficient “Quality Oversight“ on their operations and processes. The number of pharmaceutical companies that have received FDA 483s and Warning Letters indicates that management oversight of current good manufacturing practice (cGMP) compliance is a significant and continuing problem in the industry. On the other hand, FDA’s Guidance for Industry on Quality System Approach to Pharmaceutical cGMP, ICH Q9 and Q10 and EU-GMP Guide Chapter 1 have been introducing a new way of quality thinking to the pharmaceutical industry. It is now expected that the various quality systems and quality management elements are integrated and linked.
Aside from being the thesis of major FDA enforcement actions, compliance to GMP regulations is, in fact, a part of normal pharmaceutical business that requires diligent management oversight. Just as it is with other business areas, management has the responsibility to ensure that systems are in place to effectively monitor the state of control in order to intervene with timely decisions to manage risk, achieve goals, and add stakeholder value. It is of utmost importance to detect and heed possible problems early enough.
Target Group
Managers and Executives from pharmaceutical Quality Units but also Senior Management, Business Executives and Production Managers and those involved in improving the Pharmaceutical Quality System.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
Current FDA Expectations and future Developments
How the FDA defines Quality Oversight and what FDA expects from management and the Quality Control Units (QCU)
Where to find expectations and requirements: 21 CFR 210 and 211, rules and guidance, Warning Letters etc.
Typical problems FDA sees
How the industry in the U.S. is dealing with this approach
Quality Oversight – Motor in a Multinational Company
Implementation of a successful Quality Oversight strategy and program
The role of the Quality Assurance department
Definition of critical processes and integration of a management control and reporting system
Management of significant cGMP internal compliance problems and of a “warning system”
One company with various sites: how to keep Quality oversight
The link to continuous improvement
Pharma Quality System: from Compliance Check to Quality Oversight (how to get you there) – a Case Study in three Steps In this case study you will see how a multinational pharmaceutical company has gone through the transition from a fragmented Quality System to integrated Quality Oversight processes.
Part 1: Starting Point
The Warning Letter
GAP Analysis
Part 2: Implementation Phase
How to establish an appropriate meeting culture
What we can learn from ISO
The need to restructure quality departments
How to implement effective and efficient review Systems
Quality and Management Systems to lead the way to Quality Oversight
Part 3: Performance Review and Monitoring
The use of Quality Metrics
Feedback loops
Lessons learned
Case Study Roche: The Quality Product Leader Model
How a Quality Product Leader acts as a single point of contact for consistent end-to-end product Quality oversight and continuous improvement
Monthly Product Quality Report
Annual Product Quality Plan
Quality Oversight – the effective Arm in your Transfer and CMO Business
Best practise - designing and integrating Quality Oversight in transfer and outsourcing
Risk management and quality system oversight in the third party manufacturing network
How to deal with the various quality and documentation systems at different CMOs
How to evaluate CMO performance
Case Study Vetter Pharma-Fertigung: Quality Oversight in a CMO Business
Establishing a Quality Oversight system at a contract manufacturer
Interfaces to other systems
How it was seen by FDA
Person in the Plant Concept: advantages and challenges
Case Study: Quality Oversight for an interface GMP/GDP-process: Offshoring of Complaint-Handling to Shared Service Centers
Establishing a tailor-made, novel QMS incl. corresponding processes and procedures
Qualification and training of personnel for the new units
Implementing variants for multi-national and multi-language purposes
Concept for process validation and hypercare Phase
Making the new units ready for Quality audits
Several aspects of Quality oversight beyond GxP
Case Study: Quality Risk Management as enabler for Knowledge Management and Quality Oversight
How to implement QRM oversight: harmonisation as one of the key elements
Management of risks
Example of implementation of an IT tool enabling a better overview
Delimitation of responsibilities and interfaces over the product life cycle
Recording from 16/17 May 2023 Duration of the recording: approx. 8 h 30 min.
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
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