Responsible Person forum

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90.00 Minutes

CPD Hours: 1

Online

Our Responsible Person Forum, provides an opportunity for networking, sharing best practice and discussing current issues with practicing RPs and colleagues working in the GDP field. Each month has a defined topic, as follows :
  • February - Supply Chain
  • March - Deviation and CAPA
  • April - Audit preparation and hosting a customer/regulatory audit
  • May - Responding to audit observations
  • June - Data integrity
  • July - Export of medicinal products

The world of Good Distribution Practice (GDP) has developed significantly over the past few years. There has been an increase in focus from many regulatory agencies including the MHRA. With Brexit still highly on the agenda, the result of the Brexit deal will undoubtedly have an impact on supply chains for pharmaceutical products sourced from the European Union and European Economic Area. The MHRA published guidance last year to clarify and support the pharmaceutical industry and importers in the UK. RSSL recognises that there is a need to do more to assist industry in creating an environment that supports the role and responsibilities of Responsible Persons for GDP, Logistic Managers and other individuals involved in the pharmaceutical supply chain industry.


Although predominately aimed at Responsible Persons, this webinar will interest those who are working in Good Distribution Practice for medicinal products, employed by a company that has an MHRA/EU Wholesale Distribution Authorisation (WDA) license. If you are looking for an update to your existing knowledge, in particular relating to the latest current regulations in GDP, with the opportunity to ask questions and share best practice ideas whether you are an RP, Deputy RP, Quality Manager, in a QA Regulatory/Compliance or Logistics role, we would welcome your participation in this forum.
Each month has a defined topic, as follows :
  • February - Supply Chain
  • March - Deviation and CAPA
  • April - Audit preparation and hosting a customer/regulatory audit
  • May - Responding to audit observations
  • June - Data integrity
  • July - Export of medicinal products

    The webinars provide the opportunity to:


    • Network with industry colleagues
    • Share best practice
    • Discuss current issues with RSSL experts and other industry RPs and colleagues working in GDP
    • Gain greater knowledge of the changes in the world of RPs and Supply Chain
    • Share knowledge and experience and discuss hot topics, such as the Role of the Responsible Person Import RP(i)

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Meet the tutors

Jenni Newcombe

Jenni has 27 years’ experience in the Pharmaceutical industry, 8 in Quality Control and the remainder in Quality Assurance whilst working as a senior quality professional in a high volume fast paced global Generic environment. Currently acting as a Qualified Person and a Responsible Person, she has extensive experience in GMP and GDP. Jenni is currently working as the of Director Supplier Quality, Qualified Person/Responsible Person for Accord-UK Ltd (formerly Actavis UK Ltd) based in Barnstaple, N. Devon. She is responsible for UK and EU Quality teams with oversight of Contract Manufacturers/Suppliers/Service providers, the Corporate Audit team, Good Distribution Practice (GDP) policy across Europe, Middle East and North Africa, and Artwork quality related processes.

Neil Wayman

Neil is a Microbiologist with over 30 years experience in the pharmaceutical industry. Neil Treasurer of the Pharmaceutical Quality Group and actively involved in running the annual MHRA/PQG meeting. In 2012 he moved back to a role as QA Group manager, QP and RP on the license at AstraZeneca’s second largest manufacturing site at Macclesfield in Cheshire with primary responsible for the site QMS, internal and external inspections, licensing, issue management and recall. In 2018 he moved to AstraZeneca Corporate Quality as Global Quality Director primarily responsible as Global Business Process Owner for Complaints.

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