About this course
Validation is a GMP requirement for all pharmaceutical companies but, unfortunately, we have become focused on the bureaucracy of the validation process itself rather than the added value it can bring through assurance of product quality. Process validation is often simply a one-time event where three batches are manufactured and then tested, around the time of filing a regulatory submission, which alone adds very little real value to the company or to patients.
In January 2011, the FDA published their Guidance for Industry on Process Validation, which includes requirements for process design, design of facilities, the qualification of equipment and utilities, process qualification and continued process verification after product launch. Significantly, the FDA requires this new process validation approach for existing marketed products, as well as new products.
In March 2012, the EU issued a draft revision of the CHMP Note for Guidance on Process Validation along similar lines to the new FDA Guidance and EU GMP, Annex 15, is also being revised.
In addition, QbD thinking has refocused both industry and regulators on a more scientific, risk-based approach, not only to product development and manufacturing but particularly also to process validation.
The introduction of ASTM 2500 has put the spotlight on efficient and effective processes for verification of manufacturing systems and equipment and the role of the QA and Subject Matter Experts (SMEs) in validation.
This pharmaceutical training course will look at the modern approaches to process validation, including the design of facilities and the qualification of equipment and utilities. It will start by looking fundamentally at the whole validation concept, why validation makes sense and what the objectives are. The course will explain how process validation must link to patients’ needs and the regulatory requirements. It will explain how tools, such as risk management, statistics and change management, are used to accomplish this. It will show how this modern approach can add real value to your business and provide better protection to patients.
This pharmaceutical training course will also show how these concepts can be applied to existing processes with beneficial results.
What You Will Learn
- How validation activities link the patients’ needs to the product and the associated manufacturing process
- The modern regulatory expectations for process validation, including qualification and validation requirements
- How to develop a strategy for process understanding for both new and existing products that will link to process validation
- How to plan, design, execute and document qualification and validation activities
- The tools that can be used during process validation; eg risk assessment and statistical tools
- Practical application of the new FDA Process Validation Guidance
Course outline
The concept of process validation
Modern regulatory expectations
- The impact of ICH Q8, 9, 10 and 11
- New guidance on process validation (FDA and EU drafts)
- What the new FDA terms of process design, process qualification and continued process verification mean in practice
- Practical consequences of the modern scientific approach
- The roles of QA and SMEs
- Continued process verification (including ASTM E2537)
How to gain process understanding
- Identification of critical quality attributes (CQAs)
- Identification of critical process parameters (CPPs)
- Developing a strategy for process control
Process performance qualification
- Writing, approving and executing protocols
- Setting of acceptance criteria
- When to begin to commercialise
- Communication and knowledge management
Facility design and qualification of equipment and utilities
Change management
Venue
Renaissance Manchester City Centre Hotel, Manchester, UK
Located in one of the most exciting cities in UK, the 4 star Renaissance Manchester Hotel is at the heart of Manchester’s entertainment quarter. The hotel features one of the largest conference venues in the city which also provides wireless internet access.
The hotel offers spacious bedrooms with air conditioning, lounge area, excellent workspace and WIFI access.
Hotel Accommodation
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
Renaissance Manchester City Centre Hotel
Blackfriars Street
Manchester
M3 2EQ
England
Tel: +44 (0) 1618 316 000
Fax: +44 (0) 1618 353 077
www.marriott.co.uk
Hotel Bookings
If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following this link to be confirmed
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
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:
What you've said
“Tutors were excellent. They kept the energy levels up and made it fun!”
Veronica Power, Mylan Dublin Respiratory, Republic of Ireland
“Excellent tutors, who made a complex subject more easily understood by the way the material was presented.”
Alison Coates, Croda Europe, UK
“Excellent course on Process Validation.”
Niaz Ahmad, Abbott Ireland Pharmaceutical Operations, Republic of Ireland
“Course materials are excellent. Tutors are knowledgeable and friendly, much appreciated. This has been an excellent course. I’ve learnt a lot and I am sure that I can apply this to working effectively.”
Xiaolin Qi, Eli Lilly & Co, UK
“Superb!”
Anneli Andersson, Recipharm Karlskoga AB, Sweden
“Very good course, even though the principles are relatively new in validation terms. Good overview of the principles preceding PV (ie Q8, 9, 10).”
Sam Semark, Teva UK, UK
“The most useful and beneficial course I have ever attended. Covers a lot more than the title is promising.”
Hans Anderson, Bavarian Nordic A/S, Denmark
An NSF International Company 
