QP Biotechnology Issues

Quality and Regulatory Issues in Biopharmaceutical Development and Production for QPs

Pharmaceutical biotechnology is a rapidly expanding field, with a focus on the development and production of biopharmaceuticals that could lead to cures for many major diseases. 

 

It is an essential requirement that the QP understands the quality issues associated with the manufacture of these products. This workshop provides an excellent overview of the quality and regulatory issues surrounding the development and production of biopharmaceuticals for global use.  

 

Other modules in the RSSL QP Training Programme designed around the QP Study Guide will also cover biotechnology products alongside other product types, this module will provide a more in-depth overview. 

 

Interested in QP training for your team? Contact us today. 

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Duration
1 day
CPD Hours
7 hrs
Locations
  • Online

Who Should Attend

This course has value for a wide audience, as it provides a great introduction to this exciting sector. Providing a foundation level knowledge, this course will help potential contract QPs, as well as those moving into the biotechnology sector or anyone that may need a deeper understanding for auditing purposes. 

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Key topics

This course includes the following topics/sessions: 

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    What is Biotech all about? 

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    Process overview 

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    Facilities, utilities and equipment 

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    Controlling contamination 

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    Quality systems 

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    Sampling and testing 

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    Batch release 

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    Scenarios / group work and plenary discussion 

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    What does the future hold? 

Learning Outcomes

By the end of the course you will: 

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    Know how biopharmaceuticals differ from other products 

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    Know what the key regulations are and the impact they have 

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    Understand the biopharmaceutical process and the development of products 

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    Understand the facilities, utilities and equipment and how they are qualified 

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    Know what the contamination risks are and the controls to minimise the risks, including viral and TSE control strategies 

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    Understand quality systems for biopharmaceuticals 

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    Have an insight in to the types of testing regimes and their issues, during both development and licensed product manufacture 

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    Understand the batch sequencing process, the types of problems encountered during manufacture and testing and how they can be resolved 

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    Understand the future of biopharmaceuticals 

Meet your expert tutors

Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

Rebecca Rutter (1)

Rebecca Rutter

Rebecca is a Qualified Person and Responsible Person with expertise in biotechnology products and the provision of support for Advanced Therapy Medicinal Products (ATMPs). She has held director positions at several prestigious pharmaceutical companies where she has specialised in setting up and running greenfield manufacturing facilities, systems, processes, supply chain and achieving strategic business milestones.
Frequently asked questions

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, QP Trainee packages are available with RSSL and include a number of exclusive benefits. Contact our QP Training Advisor to learn more on trainingsales@rssl.com or by calling +44 (0)118 918 4000, and join our upcoming webinar, 'To QP or not to QP?', designed for aspiring QPs. 
Yes, the QP Biotechnology Issues 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 QP Biotechnology Issues 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 QP Biotechnology Issues course date that you wish to book your colleagues onto, then:

 - Add the number of people you wish to book onto the course
 - Register yourself as the booker and complete the fields accordingly
 - Add the details of those you wish to book for
 - Complete your order. 
You will receive an automated email confirming your booking details for the QP Biotechnology Issues 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 QP Biotechnology Issues 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 QP Biotechnology Issues 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.
What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Good overview

A good overview of the various Biotechnology processes and issues faced
Anonymous
Niche Generics Ltd - Commercial Director

Very Informative

Very informative
Anonymous
Almac Group Ltd - Quality Compliance Team Leader

Book Your Place

QP Biotechnology Issues
02 Dec 2024
-
Online
05 Mar 2025
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Online
12 Nov 2025
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Online
£ excl VAT
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Bespoke Training

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.

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Special Offers

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

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Further courses to consider

Why choose RSSL?

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.

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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community