This event is cancelled or expired.
Jun
2017
Techniques for Effective Failure Investigation for Sterile Products
United Kingdom, York
19 Jun 2017 - 22 Jun 2017
Entrance: £2,300.00 (excl.VAT)
Lunch:
included
Early bird and multiple delegate discounts available. Discounts also offered to NHS staff, charities and regulators.
Course Overview :
This ever-popular 3.5 day course is designed to help QA, Production and Engineering staff to take the right decisions when unexpected things happen. Through a series of real life scenarios, we will train you to use a combination of good science and risk assessment techniques to assess risk to product and patients, to take the most appropriate actions and to ensure that sustainable “fixes” are put in place to prevent re-occurrence. We cannot stop problems from occurring altogether, but we can help you to feel confident to deal with them when they do occur!
About This Course :
Learn what, when and why some risks can be justified and some not
When things go wrong catastrophically, decision making is relatively straightforward.
However, things are rarely so ‘black and white’. The biggest challenge facing anyone in sterile products manufacture is to deal with the ‘gray area’ problems which arise almost daily, requiring decisions which are:
- Scientifically justifiable
- Based on an objective and realistic assessment of RISK
- In compliance with regulatory requirements and expectations
- GOOD for your business !
The objective of this course is to help you to improve your problem solving and decision making skills when presented with any situation associated with the manufacture of sterile products. The skills you learn could save your company $millions in rejected product, regulatory censure or lost reputation.
Key Learning Objectives :
You will be given the skills and, through practice, the confidence to deal with any situation and make the right risk-based decision no matter how challenging the scenario.
For example :
- High environmental counts in a Class A (viable and non-viable)?
- Unexpectedly high pre-filtration bioburden counts?
- Momentary drop in temperature and pressure during autoclave cycle?
- Filling room occupancy higher than has been simulated during media fills?
- HEPA filter integrity test failure during requalification?
- Sterile filtration of solution takes longer than is permitted in the manufacturing instruction?
- Higher than normal reject rate during visual inspection?
- High microbial counts on hands of operator detected at exit monitoring?
- Unplanned deviation from approved sterilizer loading pattern?
…and many more
Registration link :
- NSF Online registration : Link
NSF contact :
- Phone : +44 (0) 1751 432 999
- email : pharmacourses@nsf.org
- visit : www.nsf.org/info/pharma-training
Note :
- All of our courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Course Outline :
The Theory
Lectures will cover essential information on current EU and US requirements for…
- Cleanrooms and controlled environments
- Sterilization processes
- Environmental monitoring (viable and non-viable)
- Process simulations
- Container integrity testing and visual inspection
- Environmental monitoring
- Personnel monitoring
- Cleaning and sanitization
As well as…
- Risk Management principles and the major risk assessment techniques: HACCP and FMEA
The Practice
You will be split into small ‘working groups’ and asked to take decisions on a range of scenario situations using the tools and techniques covered. A unique course providing you with a unique opportunity to improve your decision making skills.
New for 2017 – We provide an optional post-course assessment that verifies proficiency of all course attendees.
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Darren Jones
Consultant
Pharmaceutical auditing, consulting and regulatory inspection
-
John Johnson
Executive Director
NSF Health Sciences Pharma Biotech
-
Roger Guest
Consultant
NSF Health Sciences Pharma Biotech
Resume
With extensive operational QA experience at AstraZeneca and most recently as an MHRA inspector specializing in the field of sterile products, Darren is an internationally recognized expert in his field. Having unique insights into the way that regulatory agencies interpret the GMP regulations and then execute GMP inspections against the regulations and cGMPs, Darren brings a wealth of expertise and experience in auditing sterile products facilities and quality systems.
Executive Director at NSF Health Sciences, ex-VP of global quality for Hospira and an EU Qualified Person since 1995. John has expertise in QP operations, change management, GMP remediation, and sterile and biotech products.
Roger Guest is a registered pharmacist who has held senior leadership roles within R&D, manufacturing and QA with several blue chip pharmaceutical and biotechnology companies. He has worked extensively in Europe and the U.S.
His global roles have included leadership of R&D Good Manufacturing Practice (GMP) compliance teams and at a manufacturing facility level, membership of the site leadership teams.
Dr. Guest also has QA experience at department, manufacturing site and corporate levels both within R&D and production.
Dr. Guest’s areas of expertise include:
- Development of IMPs and biologicals from initial formulation through clinical trials and validation to full commercial manufacture
- Transfer of products from R&D to manufacturing
- Design and implementation of new sterile manufacturing facilities
- Active pharmaceutical manufacturing: Complying with cGMP requirements
- Auditing specialization in GMP and due diligence
- Incident management: Troubleshooting and problem solving to root cause Rapid response to global quality issues
- Quality management systems: Development through simplification
- Quality leadership: Promoting that quality makes sense for a better business and helping quality departments integrate their plans with site business plans
- Application of Lean Six Sigma tools to reduce errors and continuously improve processes
- Inspection preparation for FDA, MHRA and other agency inspections (GMP and PAI), including one-to-one preparation clinics
- Group training and one-on-one coaching for quality management understanding and application