Pharmaceutical Packaging (QLP Module 8)

About this course

Despite advances in technology, quality problems with packaging still continue to occur. Print origination and packaging processes continue to be a major reason for product recall!

This module has been carefully designed to cover all important aspects of the packaging process, from selection of suitable components, pack design, packaging processes and their associated GMP challenges, through the supply chain to the patient.

The module aims to provide the necessary understanding of packaging materials and the packaging process to enable the Technical Leaders to carry out their duties with knowledge and professionalism.
Equally, the module will be of value to staff involved in packaging development, packaging operations, materials management, QA and QC.

How This Training will Benefit You

Pharmaceutical Packaging 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 Analysis and Testing 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 Credits

‘Pharmaceutical Packaging’ offers Quality Professionals knowledge learning and an enhanced understanding of the pharmaceutical industry.

ACPE Continuing Education Units = 2.6 CEUs
Reference Activity Number 0616-9999-11-001-L05-P

Course outline

Packaging Components

• Primary (contact) materials, their composition and properties
• Choosing the most appropriate material for specific applications
• Pre-treatment of components
• Requirements for receipt and testing
• Supplier considerations

Pack Design

• Contact packaging components
• Reducing the risk of mix-up
• Industrial codes of practice

The Packaging Process

• Packaging machinery – an overview
• Packaging operations – the GMP challenges
• Recalls – an overview
• In-process controls
• Automatic security and detection systems

Regulatory Aspects

• Stability testing requirements
• Labeling regulations
• Marketing Authorisation Application requirements for packaging components

Concerns for the Quality Leader

• Counterfeits and anti-counterfeit strategies
• Controlled temperature storage and distribution
• Supplier assurance

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, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific question 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 Hotel,
Two Cambridge Center,
50 Broadway,
Cambridge,
Massachusetts 02142 USA,

Tel: 1-617-494-6600~

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:

• 

  Dr Gary Rees
  Consultant
  BPharm, PhD, CChem, MRSC, FCQI, CQP

  • [email protected]
  • +44(0)1751 432999
• 

  Mrs Susan McNeely
  Consultant
  Chemist, MS Biochemistry

  • [email protected]
  • + 1 857 277 0060

What you've said

“Susan McNeely brought very specific information, helpful examples, and good experience of the sort of problems seen in the real world. Excellent modules on transport and cold chain, packaging operations.”

James Holbrook, OPK Biotech, USA

“I was recently assigned label and pack Quality System as its process owner so this course was very timely. I appreciated that the course content was not too elementary and it held my interest for the duration.”

Cori Sandy, Biogen Idec, USA

“Excellent class. Informative and relevant.”

David Strickland, Talecris Bio Therapeutics, USA