The Role of the Quality Leader (QLP Module 12)Print
The responsibility of the Quality Leader today demands a unique skill set of technical, managerial and leadership characteristics.
$2950.00 per delegate
$2360.00 early bird booking discount
About this course
The responsibility of the Quality Leader today demands a unique skill set of technical, managerial and leadership characteristics. Risk-based decisions are made at a fast pace, issues can quickly escalate when not thoughtfully managed, and good leadership offers strategic advantage to a company. This course will assess your skill set as a leader in the context of pharmaceutical and biopharmaceutical operations and through case studies build your decision making and technical management skills.
What You Will Learn
Strategies to ensure effective and safe product release
- Role of the Qualified Person and Product Release Manager
- Case Studies in Product Release – when to say yes and when to say no!
- Evaluating the robustness of your Quality Management Systems
- Case studies in a lifecycle approach to Quality Management Systems
Expectation of Quality Management Systems Today
- Industry Context Today – Distributed Supply and Outsourcing
- Requirements of Management Today in the Context of ICHQ10
- What happens when systems break down and how to prevent breakdown
- Tips on how to avoid the cycle of reoccurring investigations and CAPAs
Leadership Skills Inventory
- Knowing your leadership challenges today and anticipating the future
- Leadership versatility as a measure of success in today’s environment
- Complexity of cross cultural leadership even on Main Street
- What pharma companies expect of their leaders and how to deliver results
Continuing Education Credit
*ACPE Continuing Education Units = 3 *Reference Activity Number = 0616-9999-11-008-L04-P
Current challenges facing the QL
- Proposed and recently implemented legislation and its implications
The role of the QL in complex manufacturing scenarios
- Managing the QMS and understanding KPI data
How to be an effective QL
- Influencing skills
Links with other functional groups
- The regulatory authorities and the inspectors Product certification/release criteria
- The decision making process
- To certify or not to certify?
- The impact of ICHQ8, 9 and 10 on the QL
- Effective decision making
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Boston Marriott Cambridge, Cambridge, MA, USA
The Boston Marriott Cambridge is situated across the Charles River from downtown Boston and is the perfect location for your next visit to the city. This Cambridge hotel is positioned in Kendall Square near popular Boston area attractions.
NSF-DBA has negotiated a preferred rate with the Boston Marriott Cambridge Hotel. A limited number of rooms are available at this rate. Hotel reservations and payment are the responsibility of each delegate.
We will be happy to help but final confirmation and bill settlement is the delegate’s responsibility.
Venue Address and Contact Details
Boston Marriott Cambridge,
2 Cambridge Center,
Massachusetts 02142 USA,
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
What Previous Attendees Said About Our QLP Courses
“Guest speaker (Matt Eversman) motivational, extremely well-spoken. Martin excellent lecturer on role of quality leader. Well versed in industry and leadership practices”
“Good use of tutors personal experience in the industry – liked the problem solving case studies particularly”
“This course has helped me to refocus and re-organize as to what I need to be focusing on. It has helped me to prioritize what I would like to change within my own group and company and given me some tools to use in implementing the changes”
“The material and experience is so practical, you can apply it to all aspects of your life not just your profession”
“Good course, I really liked the free-flowing direction of the course and not just plowing through the lectures.”