Pharmaceutical Packaging
What you'll gain from this course
Why are packaging‑related errors still a leading cause of recalls? This highly interactive course explores that question. It equips aspiring QPs and pharma professionals with the knowledge to manage, oversee, control and audit all aspects of packaging operations - from regulatory requirements and component control to packaging line design and distribution.
Take practical improvement ideas back to your workplace. The course covers key elements of the packaging process and associated GMP and PQS challenges, including material selection, pack design, security, and process control. From components to patient, you’ll review the end‑to‑end supply chain and learn how to design a packaging operation ready for inspection.
This course is approved by the Royal Society of Chemistry for continuing professional development.
Course Outline
- Packaging Components
- Primary materials: composition and properties
- Selecting suitable materials
- Artwork management
- Receipt, sampling and testing
- Supplier considerations, audits, agreements and standards, e.g. PS 9000
- Regulatory Aspects
- Marketing authorisation requirements
- Labeling regulations
- Stability testing
- 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
- Discussion and Working Groups
- 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.
Course Tutors
Samantha Clack - 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 - 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 - has worked in QA and production operations management roles and is eligible to act as a QP. Instrumental in the start-up of a new oral solid dose manufacturing and packaging facility in the UK.
Kate Krachai – has over 20 years’ experience in the pharma industry across key positions in quality management and as a pharma lead auditor. Has extensive experience in pharmaceutical development, manufacture and supply of marketed and investigational medicinal products (IMPs) and the associated pharma quality system.
Discounts
Multiple delegate discounts are available on this course. Please contact us at [email protected] for further information. NHS staff will receive an automatic discount when registering with an NHS email address.
Learning Outcomes
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
Who Should Attend
The Aspiring Qualified Person
- Our training is generally considered 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 other 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 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.
Need help choosing?
Our training advisors can help you find the perfect match.