The Role of the Quality Leader (QLP Module 12)

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

• Risk-based decision making and problem solving: How to make the right decisions, at least most of the time!
• Product release decision making: When to say yes and when to say no!

Management and organizational structures

• What makes people ‘tick’
• How to motivate others
• Human error: Causes and prevention

The leadership ‘tool kit’

• How to communicate with influence
• The art of negotiation: Getting to ‘win : win’… even with your boss!
• How to keep your sanity in a (sometimes) insane world
• How to lead change effectively
• Crisis management and prevention: The essential ‘rules’
• Managing across cultures:

How This Training will Benefit You

The Role of the Quality Leader represents a key element for the Quality Leader and the Technical Professional. This course provides the tools and techniques required to make informed, science and risk based decisions to benefit both the business and the patient.

It will provide the background and knowledge needed by every Quality Professional and Technical Leader whether in Production, Quality, R&D, Validation, Engineering, or any other technical discipline. As with all of NSF-DBA’s courses, it is led by industry and academic experts; frequently incorporating case studies and small group sessions to facilitate learning.

NSF-DBA’s format of extended days and pre-work ensures that both you and your company benefit from the learning experience in an efficient way and with minimal time away from the workplace.

This course on The Role of the Quality Leader is based upon a key component of the Qualified Persons instruction which NSF-DBA offers in Europe. It sets a new standard for practical, results oriented instruction.

A Certificate is granted by NSF-DBA for attendance. Higher degree options – a Diploma and a Masters in Pharmaceutical Quality and Good Manufacturing Practice from the University of Strathclyde can be obtained by attending a full series of courses.

Continuing Education Credit

ACPE Continuing Education Units = TBC
Reference Activity Number = TBC

Course outline

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?

Facing risk

• 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.

Venue

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.

Hotel Accommodation

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,
50 Broadway,
Boston,
Massachusetts 02142 USA,

Tel: +1-617-227-0815

Tutors

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:

• 

  Mr Jim Morris
  Partner
  BA Biol, MSc, MBA

  • [email protected]
  • + 1 857 277 0060
• 

  Dr Peter Calcott
  Consultant
  PhD

  • [email protected]
  • + 1 857 277 0060

What you've said

What Previous Attendees Said About Our QLP Courses

“Outstanding course! I will be recommending the program to my colleagues and registering my direct reports. Workshops are effective in exchanging industry experience and promoting team and group cohesion and good dynamics”

Jose Torres, OPK Biotech

“Course instructors and professors are always excellent. Thank you for another great course. I found the pre-read material very helpful in preparing for the class”

Debra Lane, Shire

“This course was great! The information presented was very applicable and the presenters were very knowledgable. A good mix of lecture and teamwork exercises. I enjoyed the stories of the presenters and their sharing of personal experiences”

Charles Carlile, Watson Pharmaceuticals

“It is an exceptional opportunity to participate in a development course which includes instructors with ‘real’ industry experience and much history collaborating with regulatory bodies”

Paula Blalock, Alelrgan Inc