Pharmaceutical Packaging Training

Why are packaging related errors still one of the greatest causes of recalls?

This highly interactive four-day pharmaceutical packaging training course is designed to answer that question. It provides aspiring Qualified Persons and other pharmaceutical professionals with the knowledge and understanding they need to manage, oversee, control or audit all aspects of packaging activities. Topics range from the regulatory requirements for packaging and control of packaging components to the design of packaging lines/process and distribution of medicines.

Take ideas for improvement back to your workplace. Our QP pharmaceutical packaging course covers all important aspects of the packing process and their associated Good Manufacturing Practice (GMP) and pharmaceutical quality system (PQS) challenges. This includes selection of suitable materials, pack design, pack security and design/control of packing processes. From starting components to patient, our course provides a detailed review of the supply chain so you can design your ideal packaging department that is ready for inspection.

This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.

On completion of this QP pharmaceutical packaging course, delegates will know and understand:

• The QP study guide expectations for packaging
• Background on different packaging materials and their selection, uses control and impact on product stability
• Packaging design considerations to protect both the product and the patient including labelling, anti-counterfeiting, tamper evidence and serialization
• Regulatory aspects of packaging design, usability and stability programmes.
• Supply chain management from supplier selection to contract manufacturing organizations (CMOs), distributors, storage, transportation and the patient
• Packaging operations and their risks and control
• New changes and challenges to packaging
• Packaging issues impacting QP and quality assurance (QA) decisions

Packaging Components

• Primary (contact) materials, their composition and properties
• Choosing the most appropriate material for specific applications
• Artwork management
• Requirements for receipt, sampling and testing
• Supplier considerations, audits, agreements and standards, e.g. PS 9000

Regulatory Aspects

• Marketing authorization application requirements for packaging components
• Labeling regulations
• Stability testing requirements

Pack Design

• Good design practices to aid the manufacturer, distributor, retailer and patient
• Reducing the risk of mix-up

Packaging Process

• Packaging operations (the GMP challenges)
• Facility design considerations
• Packaging machinery (selection and qualification)
• Process qualification and validation
• Automatic security and detection systems
• Start-up checks and in-process controls
• Line clearance and cleaning
• Batch packaging record design and reconciliation

Route to the Patient

• Fundamentals of Good Distribution Practice (GDP)
• Controlled temperature storage and distribution
• Wholesale dealing (includes a visit to a wholesaler)

Concerns for the QP

• Counterfeits (anti-counterfeiting, tamper evidence and serialization)
• Controlling packaging processes

A significant portion of course time is devoted to group work. Using case studies, delegates get the opportunity to put theory into practice. Additionally, discussion periods (which include a course tutor panel session) provide you with an opportunity to obtain answers to your specific question and concerns.

The Aspiring Qualified Person

• Our training is generally considered as the best available and our QPs are held in high regard in the industry.
• As well as being accepted in the UK, our training courses are well known and accepted by several EU countries, including Ireland, the Netherlands, Austria, Hungary and Malta.
• You are more likely to become a QP with us than with any other training provider.

The Pharmaceutical Technical Professional

• Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture, Quality Assurance and control.
• Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.

Course tutors will be selected from the following:

Samantha Clack - Samantha has worked in the pharma industry for over 20 years, and has been an active QP at licensed packing facilities for over half that time. Also an experienced auditor, Samantha has audited packaging facilities worldwide.

David Waddington - David has broad experience in QA and manufacturing management, working with a wide range of dosage forms for global supply including solids, liquids, sterile products, food supplements and natural products.

Catherine Kay - Catherine has worked in QA and production operations management roles and is eligible to act as a QP. She was instrumental in the start-up of a new oral solid dose manufacturing and packaging facility in the UK.

Kate Krachai – Kate has over 20 years’ experience in the pharmaceutical industry across key positions in quality management and as a pharma lead auditor. Kate has extensive experience in pharmaceutical development, manufacture and supply of marketed and investigational medicinal products (IMPs) and the associated pharma quality system.

All above tutors eligible to act as a QP.

Multi-delegate discounts available. Discounts also offered to NSF staff and charities.