QP hot topic webtorial

90.00 Minutes

CPD Hours: 1


These 90 minute interactive Hot Topic WebTorials are on-line, highly interactive Webinars where participants work through real-world scenarios designed to test knowledge, problem solve and find resolutions using risk assessment techniques. Participants can then apply new ways of thinking in their day-to-day roles. The sessions run once a month on a Friday and start at 9.30am till 11am.

They bring RSSL’s expertise and support direct to you, enabling you to learn in short time-friendly bursts without any travel and accommodation costs. An action centred learning approach within a framework of pragmatic tasks, issues, and problems that are aligned with real workplace concerns. Presented with a ‘progressive scenario’, and facilitated by the Tutor, attendees will be expected to solve problems in real time utilising their pre-existing knowledge and experience. By sharing best practice across a wide range of different backgrounds, dosage forms and technologies you will develop your critical thinking and decision making skills.

The sessions provide reinforcement to delegates who have joined our Qualified Person Training and Viva Support Programme and are primarily intended for Trainee QPs and Qualified Persons. Specifically:

  • QP trainees regardless as to where in the process you are
  • QP trainees about to submit their forms
  • Newly qualified QPs looking to update their knowledge and develop a network
  • Experienced QPs looking to update their knowledge and network
  • Regulatory and quality professionals impacted by the topics under discussion
  • Any manufacturing or supply chain professionals impacted by the topics under discussion

However, they are equally relevant for those needing to advance their GMP, GDP, Quality Assurance, Quality Control and Production knowledge.
All sessions will be scenario based and may not be limited to the topics outlined below and may also cover other topics.

  • April - Annex 1
    • Not just microbiology – so what else is in a CCS
    • b. RABS or not
    • What are your biggest concerns about implementation and why?
  • May - CTD update
    • What's new
    • What’s the dates for changes
    • How are current trials impacted
  • June - VMD divergence between EU and VMD legislation becoming apparent
    • How to handle labelling differences
    • Consultations in progress: regulations, importation, interim measures
    • Anti-microbial resistance and why this is important to humans
    • Residue in food safety consultation ends July 2024
  • July - Supply chain control issues maps
    • What is a SCM?
    • Why is control of outbound goods as important as inbound goods?
    • What if it goes wrong? Recalls.
    • Supply chain viva questions
  • August - Analysis and Testing
    • When it goes wrong
    • Limitations of methods and watch outs
    • Transfers - China says validate not qualify only
  • September - Microbiology in water
    • Being good friends to horseshoe crabs
    • Water systems and micro analysis
    • Impact of failures of micro

    By joining our monthly WebTorials you will:

    • The legal requirements will be identified
    • Identification of problem areas to focus on in day-to-day operations
    • The legal requirements will be identified
    • Identification of problem areas to focus on in day-to-day operations
    • How to answer viva questions discussions
    • Provide tools for QPs facing similar real-life scenarios to make informed decisions for investigations
    • Network with industry experts and like-minded professionals
    • Set the agenda for future workshops

    Don't miss this opportunity to delve into quality topic all QPs face, ensuring you can handle viva scenarios from a strong knowledge bases or lead your organisation when problems arise.

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Special offer

Helping your training budget go further

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

Meet the tutors

Rebecca Rutter

Rebecca is a Qualified Person and Responsible Person (Eligible to act as a Qualified Person under the permanent provisions) with expertise with Biotechnology products and provision of support for Advanced Therapy Medicinal Products (ATMP). She has held Director positions at some of the most prestigious pharmaceutical companies where she has specialised in setting up and running greenfield manufacturing facilities, systems, processes, supply chain and achieving strategic business milestones.

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