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Sept.
2017

Techniques for Effective Failure Investigation

Royaume-Uni, Manchester

26 sept. 2017 - 27 sept. 2017

Entrée : 1 540,00 £ (HTVA)

Déjeuner: inclus
Early bird and multiple delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
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Course Overview:

A highly interactive 2 day course designed to provide you with the tools and techniques to improve your decision making skills and better protect your company and the patient. We will show you how to take a structured, risk-based approach to problem solving and decision making, using techniques such as FMEA, HACCP, FFA and others. You will practice using these new skills via real life scenarios and case studies. We will give you decision making checklists and process flows to use in the workplace and teach you how to turn data into information. In short, we will provide you with the skills and tools to take better decisions at work!


About This Course:

GMP depends on the right call at the right time for the right reasons with written justifications available 

This course focuses on how to make the right quality decision in tough situations with finite information, short deadlines and high pressure! Utilising a range of scenarios across the common pharma dosage forms, the course is jam-packed with real-life GMP non-conformances, product quality concerns, customer complaints, change control requests, ‘uncontrolled’ variations, potential market actions and field alerts – helping you to see how to make more effective risk-based decisions at your workplace.

Life is rarely black and white, and it is those situations in the gray zone where your powers of risk identification,
risk assessment, prioritisation, execution and post-event verification are really tested. Taking a structured approach to
decision-making is critical in proposing the best ‘next steps’ and on this course you will spend time practicing a proven
approach, evaluating your decisions and learning how to deal with a range of issues that challenge the quality attributes of pharma products.

Hindsight tells us that the wrong decision (or no clear decision!) at the wrong time can make or break a company or its supply chain. Some scenarios may only present themselves once or twice in a career, so attending this course concentrates a range of tough scenarios into two intensive days where we present some proven tools and then work alongside you to resolve several typical product quality issues.


What Would You o About The Following:

  • You manufactured a batch with unapproved materials but QC test results are fine.
  • You have a choice of supplier. One cheap, the other less so. Which one do you choose? Why?
  • Your maintenance is overdue on top of an odd calibration failure. Thoughts?
  • Which contractors do you audit more frequently than others?
  • If you have limited engineering resource where must you focus?
  • Your regulatory inspector leaves you with a list of things to fix. Where do you start?
  • You’re designing a new plant. What are your priorities?
  • What signatures can you remove from the batch record to make it simpler? Some? Lots?
  • Your HVAC fails during manufacture (product contained). Do you carry on or stop?

First fact of life: Risk is everywhere.

Second fact: If you want to succeed and prosper you must have excellent risk-based decision making skills!

Thirdly: Avoid ‘gut feel’ decisions or worse still, no decision at all!


Key Learning Objectives:

Your Return on Investment

We don’t believe in ‘death by PowerPoint’. We want you to learn, be engaged and have fun as well. Carefully designed case studies, teamwork tasks and problem solving exercises (facilitated by highly experienced course tutors) will ensure that you ‘learn by doing’. You will learn:

  • How we humans make decisions. We are actually conditioned to think quickly, not accurately! This course will transform your decision making processes
  • How to design a simple, structured decision making process that will give you the right answers to the biggest challenges most of the time
  • How to use ICH Q9 (Quality Risk Management) in your decision making proactively and in response to deviation, unexpected events and crises
  • How to use risk-based decision making proactively to prevent problems, simplify systems, add value and minimize risk
  • How to make those gray area decisions where time and information are both limited

You will practice your decision making skills on a wide range of scenarios. Exercises (customized to meet your needs) will allow you to practice the tools and techniques so that by the time you leave you are ready for even the toughest decisions.



Registration link :

  • NSF Online registration : Link

NSF contact :

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:

Risk-Based Decision Making – The Theory:

  • Practical implementation and use of ICH Q9 ‘Quality Risk Management’
  • Good decision making practices (reactive and proactive)
  • Failure Mode Effect Analysis (FMEA) and Hazard Analysis Critical Control Point (HACCP)
  • Force field analysis, Fishbone diagrams and many more techniques!

How to Investigate and Make the Right Risk-Based Decision Relating to Some Common Scenarios:

  • Product release: What do you do with the ‘imperfect’ batch? Release or reject?
  • Stability test failures
  • Product recalls and customer complaints
  • Deviations and CAPAs
    • How to assess critically and identify CAPAs that are effective in preventing recurrence of the issue
    • How to handle deviation incidents
    • What to do when you can’t find root cause
    • How to prevent deviation ‘overload’
  • Procedural non-compliances: How to assess risk and prevent recurrence
  • Raw materials: Management of out of specification and out of trend results
  • Environmental monitoring excursions (viable and non-viable particulates)
  • Utilities: What to do when your water and HVAC systems ‘crash’!
  • Management and risk assessment of packaging related ‘mix-ups’
  • Cross-contamination incidents: What to do when you find the unexpected
  • Warehousing and distribution: How do you manage those temperature excursions?

New for 2017 – We provide an optional post-course assessment that verifies proficiency of all course attendees.

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    John Wilkinson

    Consultant

    NSF Health Sciences Pharma Biotech

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    Darren Jones

    Consultant

    NSF Health Sciences Pharma Biotech

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    John Johnson

    Executive Director

    NSF Health Sciences Pharma Biotech

Suivant

Résumé

John Wilkinson has over 40 years’ experience in the pharmaceutical industry. He is a chemist by profession, a Qualified Person and a member of the Royal Society of Chemistry.

Having spent most of his working life as a quality leader, John has been particularly involved in continuous improvement, education, decision making, compliance drift and remediation.

Before becoming an NSF Health Sciences consultant in 2015, he was UK Technical Head and Head EU QP with Dr Reddy’s Laboratories (UK) Ltd for 10 years, specialising in import of generic dosage forms from its manufacturing bases in India. This role involved regular QP audits/inspections of Dr Reddy and third-party manufacturing facilities in India as well as audits of Dr Reddy and third-party API manufacturing sites.

Earlier in his career, Mr. Wilkinson was with Reckitt & Colman and covered oral solid dose, liquids, creams and terminally sterilised products as a QP. He also worked for CCL Industries (UK), an FMCG contract manufacturer of pharmaceutical topical aerosols for many UK clients.

Darren Jones has 25 years of experience in pharmaceutical auditing, consulting and regulatory inspection support and preparation. Prior to joining NSF, Mr. Jones worked at MHRA where he spent four years as a GMP inspector. He inspected many sites of varied dosage forms worldwide and developed considerable experience of complex aseptic manufacture and terminal sterilization for both commercial and clinical trial applications.

Earlier in his career, Mr. Jones spent 18 years in a number of roles at AstraZeneca, including production outsourcing, selecting and managing contract manufacturing sites primarily engaged in sterile manufacture.

Mr. Jones has provided QA support to an API facility which included laboratory-scale production for parenteral products, traditional manual plant and modern computer-controlled facilities. He has also provided QA support to tablet processing and packaging activities.

Mr. Jones’ areas of expertise include:

  • GMP auditing of facilities and processes
  • Sterile manufacture
  • Clinical trial manufacture
  • Supply chain excellence
  • Microbiological QC

John Johnson is passionate about helping organizations foresee and overcome the barriers to sustainable long-term growth. He brings 28 years’ experience across a range of companies in the pharmaceutical and healthcare industry. He has worked in small, medium and large pharma biotech companies across the product lifecycle for a wide range of dosage forms. He has senior operational and corporate-level experience in operations and quality assurance and has led multinational companies in strategic projects associated with:

  • Inspection readiness and remediation (in UK, Italy, France, Australia, Singapore, India and USA)
  • Crisis management including handling of regulatory authority actions, multinational recall and import bans
  • Major culture change to improve customer service, quality, cost or “on time in full”
  • Installation, monitoring and periodic effectiveness checks on site or company quality management systems
  • Paradigm shifts including downsizing, upsizing, mergers and acquisitions
  • QP development, training, mentoring and resource management
  • Lean projects in QC laboratories and OSD facilities
  • Management review and escalation processes from shop floor to boardroom level

Mr. Johnson has used research with subject matter experts from Toyota and Tata to help firms streamline and simplify complex processes and procedures to reduce cost, rework, rejects and human error. By working with a range of companies across a variety of cultures, dosage forms, business plans and geographies, he has acquired a style that has a proven methodology yet is easily tailored to suit the particular need.

A QP since 1995 and a QP Assessor since 2005, he has been a sponsor and mentor for QPs, some of whom are QA department leaders. As a Fellow of the Royal Society of Chemistry, he is laser focused on the value that good analytics bring to batch dispositioning decisions and has a particular expertise in data-based, quality risk management.

Utilizing a range of development tools and techniques, Mr. Johnson has been responsible for developing quality and operational teams to be aligned and engaged with the company’s strategy so that the team’s combined output is driven by a performance culture that is self-governing yet capable of constant re-analysis and refreshment. He has also written articles for a variety of pharma publications.

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