Do you find yourself struggling to keep up with the ever-increasing expectations of regulators regarding supplier qualification and auditing in the pharmaceutical industry?
It’s challenging to interpret and implement new guidelines, like the recently updated USP Chapter <1083>, which can be confusing and overwhelming. This can lead to delays, higher costs, and even product recalls or patient harm. It’s essential to ensure that your supplier qualification and auditing practices are robust and compliant to avoid the severe consequences of regulatory scrutiny.
We understand that the consequences of inadequate supplier qualification and auditing practices can be far-reaching, so we’re here to help.
Our upcoming webinar will provide you with the knowledge and tools to confidently navigate the regulatory landscape and achieve compliance. Our expert, Paul Palmer, will guide you through the intricacies of supplier qualification and auditing, focusing specifically on interpreting the new USP Chapter <1083>.
You’ll understand regulatory expectations comprehensively and learn effective organisational implementation strategies.
Don’t let the complex landscape of supplier qualification hold you back. Join us and gain the knowledge you need to succeed.
Paul PalmerManaging Director at Pharma Quality Services LTD
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU /UK Qualified Person since 2004. He has over 36 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices. Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerized systems, as well as the facilities and services to support each.
Qualified as a Lead auditor, Paul has been auditing suppliers and internal management systems since 1998 and still remembers the advice of his manger Robert Whitham on his first solo audit. Remember not everyone does GMP the same way, just because they don’t do it the same way as us doesn’t mean its wrong. Seeing new ways and applying the knowledge to other fields or companies allows Paul to think laterally often developing a creative solution no one else considered.
People and systems have always been a core focus, how to ensure best use, optimize and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Educationally Paul has a Degree in Applied Biology, an MSc in Quality Management, a Post Graduate Diploma in Pharmaceutical Studies and an EMBa in Business administration all of which bring more depth to his experience and knowledge
Who Should Attend:
- Quality Managers, Head of Quality, Quality Director, Risk Management Specialist and Supplier Quality Managers
- Skill Level: Intermediate , Expert
Introduction (5 minutes)
- Welcome and introduction to the webinar
- A brief overview of the importance of supplier qualification and auditing in the pharmaceutical industry
- Setting the stage for understanding the challenges and expectations of regulators
II. Understanding the Regulatory Landscape (15 minutes)
- Overview of global regulatory bodies and their expectations for suppliers' qualification and auditing including EU and UK
- Key regulations and guidelines impacting supplier qualification, including the new USP Chapter <1083>
- The consequences of non-compliance and the importance of meeting regulatory expectations
III. Exploring the New USP Chapter <1083> (20 minutes)
- Detailed analysis and interpretation of the new USP Chapter<1083> guidelines for supplier qualification
- Understanding the key elements and requirements outlined in the chapter
- Addressing common misconceptions and challenges associated with the implementation of the new guidelines
IV. Best Practices for Supplier Qualification/Auditing (25 minutes)
- Essential steps for effective supplier qualification and auditing
- Establishing a risk-based approach for supplier evaluation and selection
- Implementing robust auditing processes to ensure compliance and quality assurance
V. Tools and Techniques for Compliance (15 minutes)
- Leveraging technology and automation for efficient supplier qualification and auditing processes
- Documentation and record-keeping strategies to demonstrate compliance
VI. Discussion of some deficiencies and Q&A published by the authorities
- Discussion of some deficiencies
- Review of Q&A published by the authorities
Special event information:
- All participants will get a complimentary certificate of attendance courtesy of the webinar's sponsor - Pharmalane UK.
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