Auditing to Pharmaceutical Standards
Quality audits play a crucial role within the pharmaceutical industry, ensuring that the complex system of processes and operations of your company (and those that you work with), comply with industry standards.
Within the sector, Active Pharmaceutical Ingredient (API) manufacturers, contracted-out laboratory services and suppliers of key excipients and packaging materials can all expect to be audited to help ensure compliance and protect the end user.
This one-day course delves into the relevant standards that you can expect to audit against, covering EU GMP Parts I, II and III; PS 9000; ISO 17025; ISO 15378, ISO 13485 and several elements of ISO 9001 (Quality Management Systems).
Interested in audit training for your team? Contact us today.
Ideal for those who undertake external supplier audits, or Qualified Persons (QPs) looking for CPD, this course is ideal for those who wish to gain an appreciation of the listed standards to effectively conduct audits of the sector and its allied industries.
The course covers the following topics:
EU Guide to GMP and supplier requirements API GMP and ISO 9001
Excipients
Packaging: PS9000 and ISO 15378
ISO 17025 (Contract Testing)
Good Distribution Practice (GDP)
Medical Devices ISO13485
By completing this course, you will be able to understand the structure and key requirements of:
EU GMP Part I - Basic Requirements for Medicinal Products
EU GMP Part II - Basic Requirements for Active Substances used as Starting Materials
EU GMP Part III - ICH Q9, ICH Q10, ISO 9001 - Quality Management Systems
PS 9000 - Good Manufacturing Practice relating to the manufacture of packaging materials for medicinal products
EXCiPACT and IPEC/PQG GMP guide for pharmaceutical excipients
ISO 17025 - competence of testing and calibration laboratories
ISO 13485 - Quality management systems for Medical Devices
ISO 15378 - Primary Packaging Materials
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.
Yes, the Auditing to Pharmaceutical Standards course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details.
Places will be available for you to book unless it states ‘Full’ next to your chosen Auditing to Pharmaceutical Standards course date. When this occurs, we operate a waiting list service.
Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems.
You will need to first register yourself on our booking system by selecting the Auditing to Pharmaceutical Standards course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the Auditing to Pharmaceutical Standards course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included.
Usually, this 1-day Auditing to Pharmaceutical Standards course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000.
Our online Auditing to Pharmaceutical Standards course begins at 09:00am, although we request that you login at 08:30am to ensure any technical glitches can be resolved before the start time. Please review your course confirmation email to double check the exact start time of your specific course.
Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system.
Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you.
Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address.
Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email.
As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage.
Please see our 'minimum requirements' document for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test.
Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees.
All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK.
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
