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Course Information This one day course is designed to provide you with comprehensive guidance and practical help for when designing and implementing audit programmes. Using the guidance of ISO 19011 with reference to PV, GCP, GMP and GLP audit programmes, you will explore audit programme design, operation, review and improvement. The course will work through why audits are important and understanding the drivers behind a good audit programme. It will discuss how to identify and assess the risks in your organisation, linking them with organisational goals, using these risks as a basis for the design of a risk-based audit programme during facilitated practical workshops. Delegates will have the opportunity to consider and discuss common issues and constraints that may shape their audit programmes. By the end of the course you will have: A clear understanding of the role of audit programmes in managing compliance and of the drivers and risks behind audit programmes An understanding of the roles and responsibilities of management and personnel An appreciation of resourcing implications and auditor attributes A good insight into the practicalities and activities required for design of risk based audit programmes A comparison of your circumstances, challenges, common issues and ways to approach managing audit programmes with other delegates on the course. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:15 Why do we Need to Audit? Exploring risk and regulation, responsibility and performance. 09:45 Discussion - Programmes, Needs, Commonalities Understanding the needs of delegates' own organisation and comparing common themes and threats. 10:00 Establishing an Audit Programme Design, objectives, risk and resources. This session discusses the consideration when designing audit programmes. 10:30 Break 10:45 Risk Management Considerations, guidance and methods for assessing and controlling risk. 11:00 Workshop 1 - Risks, Prioritisation and Control Looking at specific risks, assessing and evaluating to feed into audit programme management. 12:00 Workshop 1 - Feedback 12:30 Lunch 13:30 Putting it into Practice Resources, practicalities and challenges - the realities of auditing, including selection of auditors, ensuring practice will meet expectations and the reasons to note audit results. 13:45 Workshop 2- Designing Audit Programmes Designing audit programmes using output from risk assessment process. Challenges and flexibility. 15:00 Break 15:15 Workshop 2 - Feedback 15:30 Monitoring, Reviewing and Improving Why or when should existing processes change, understanding the implications of change or inaction and exploring how to improve the audit programme. 16:15 Panel Session This final session will address any outstanding issues raised by delegates. 16:30 Close of Course Extra Information Remote Course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device< Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking You will need a stable internet connection, a microphone and a webcam. CPD Points 7 Points Development Level Develop
Course Information This course offers foundational guidance and practical support tailored for individuals operating within Good Manufacturing Practice (GMP) frameworks. Explore the fundamental prerequisites of a pharmaceutical quality system (PQS) and delve into the application of quality risk management (QRM) principles, aligning with current regulations and guidance. Gain insights into pivotal aspects such as requirements, roles, and responsibilities, encompassing change control, document management, and key documentation essential for effective implementation of GMP with a focus on regulatory inspections and common findings. Is this course for you? Ideal for professionals engaged in GMP across various sectors, including: Research and Development (R&D) Contract Manufacturing Organisations Manufacturing Units Quality Control (QC) Laboratories Auditing Roles. What will you learn? Event objectives - by the end of the course, delegates shall: Have an awareness of the basic requirements of GMP Be aware of UK and EU GMP Rules and Guidance and relevant publications Understand the roles and responsibilities associated with GMP Be able to contribute to and maintain quality documentation Have a basic understanding of product lifecycle and manufacturing Understand the requirements of GMP in the QC laboratory context Have a basic understanding of risk management and mitigation principles Understand the need for quality systems and quality assurance activities Be aware of common regulatory findings. Learning outcomes: delegates will be able to: Implement their role within GMP with confidence and knowledge of the principle requirements Contribute effectively to the GMP quality system and their organisation’s compliance Comprehend where their organisation’s activities sit within the larger GMP arena Know where to seek further information within the published rules and guidance, UK Legislation, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Programme Please note timings may be subject to alteration. Day 1 09:30 Introductions and Scope of the Course Understand the group requirements and the tutor's background and experience. 09:45 Background and Regulatory Environment Setting the scene, understanding the context, key legislation. 10:30 Principles of GMP Key points and requirements. 11:15 Break 11:30 Personnel and Responsibilities Management and staff, duties and accountabilities. 12:00 Overview of GMP Manufacturing Basics of the product life cycle. 12:30 Lunch 13:15 Risk Management Workshop Practical exploration of risk and mitigation activities. 14:30 QC Laboratories Activities and practicalities. 15:15 Break 15:30 Compliance Quality Assurance and Self Inspection. 16:15 Question Time A chance for questions on the practicalities of GMP. 16:30 Close of Course Extra Information Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 7 Points Development Level Learn
This comprehensive online interior design course includes 12 self study modules, and weekly 1:1 telephone and or video consultations. I will personally guide and inspire you through your creative learning journey.
Women in Healthcare Leadership Workshop Our Aims For This Workshop: Become clear about your leadership style and philosophy. Understanding how to navigate yourself and your team in a VUCA environment. How to communicate with presence and impact. Topic 1 Foundations For Effective Leadership Develop your leadership story – (know yourself) Your values, influences and leadership philosophy Clear vision and purpose as a leader Adapting style to suit the context Topic 2 Leading Through Rapid Change (Uncertainty) Exploring the VUCA environment (Volatile, Uncertain, Complex, Ambiguous) Understanding the psychological process of change Resilience and stress management Topic 3 Communication Skills For Influential Leaders How to prepare to be present so you have a presence Explore and understand your own innate communication style Importance of voice, pace, trust, and rapport THE FACILITATOR Ruth Sangale Ruth has 20 years HR and OD experience in the public and private sectors, leaving the NHS in 2012 to set up her own business “Enjoy Work” and specialise in Creative Leadership development and executive coaching. She works internationally coaching and running residential leadership programs for global organisations such as UNICEF, WHO, UN Women, and PLAN International and charitable NGOs in a range of countries including, Afghanistan, Brazil, India, Kenya, and Belize. In the UK she designs and delivers workshops for mostly the NHS, on topics such as career development, resilience and positive psychology, feedback skills, coaching skills for leaders and team development. She is an ICF-accredited coach and has an M Sc in Innovation, Creativity and Leadership. In her work she uses creative tools such as drama, visualization, drawing, mindfulness and storytelling to stimulate creative thinking and develop leadership capability. She has two daughters and in her free time loves hiking, climbing mountains and salsa dancing. THE PANEL Sam Foster - Chief Nursing Officer - Oxford University Teaching Hospitals Sam joined the Board of Oxford University Hospitals NHSFT in September 2017 as an experienced Chief Nurse who previously worked at the Heart of England NHS Foundation Trust where she held the role of Chief Nurse for four years. Sam has also worked in a number of Trusts in clinical, operational and educational roles. Sam's portfolio includes the professional leadership and education of over 5,000 Nurses, Midwives and AHPs. In addition to the Executive leadership of the Trust Facilities and PFI Services, she is accountable for the Estates and delivery of the capital program. Sam leads the Urgent Care program across the Oxfordshire system. Avey Bhatia - Chief Nursing Officer - Guys & St Thomas’ NHS Trust Avey Bhatia is Chief Nurse at Guy’s and St Thomas’ Trust. Avey returned to the Trust as Chief Nurse in November 2020, having trained as a critical care nurse at St Thomas’ in the early part of her career. Avey qualified in 1991 and her clinical experience includes theatres, general intensive care, coronary care and cardiothoracic nursing. She held various staff nurse and sister posts at hospitals in London before becoming Chief Nurse and Director of Infection Prevention and Control at St George's University Hospitals NHS Foundation Trust in 2017. Avey holds a postgraduate diploma in health services management and a Masters in Public Administration. She is also the Trust’s Director of Patient Experience, and the executive lead for adults’ and children’s safeguarding, and for infection, prevention and control. Beyond Guy’s and St Thomas’, Avey is Vice President for the Florence Nightingale Foundation and Honorary Vice President of The Nightingale Fellowship. She is a Trustee for the St John of Jerusalem Eye Hospital Group. Caroline Alexander CBE - Group Chief Nurse - Barts NHS Trust Caroline graduated as a nurse in 1987 from Edinburgh University (BSc/RGN) and has an MSc in Nursing Studies from South Bank University (2001). From 1987 to 1993 she specialised in nursing older people in Edinburgh and then London at Guy’s Hospital as a ward sister. Caroline then worked for the Foundation of Nursing Studies for three years supporting nurses to use research in practice. In 1998 Caroline returned to the NHS and worked in Tower Hamlets in a range of roles within older people’s services. In 2005, Caroline took up her first Director post, as Director of Nursing and Therapies within Tower Hamlets PCT. With the clustering of PCTs in London in 2011, she took on the Director of Nursing and Quality within NHS East London and the City initially and then within NHS North East London when the clusters merged in 2012. until she joined NHS England as Regional Chief Nurse for London in April 2013. Caroline took up her current role of Chief Nurse for Barts Health in March 2016. Caroline was a 2008 Florence Nightingale Leadership Scholar and has been awarded Honorary Doctorates from City, University of London in 2017, Middlesex University in 2018 and University of East London in 2021. She is a Trustee of the Foundation of Nursing Studies. In 2020 she was made a CBE in the Queen’s Birthday Honours. Who will attend? Emerging Leaders looking to step into management roles Current Leaders looking to progress into senior management roles This workshop is open to any woman who works in health care and wants to take her next step in their career; women include trans women and non-binary people who are comfortable in a female-centered group. Group Rate Discounts 2-3 people, 7% discount 4+ people, 20% discount We have two group rates which you can take advantage of depending on the size of the group you wish to book: Option 1️⃣ Groups between 2 & 3 are eligible for the 7% Discount. Please use this code at checkout: GROUP 2+ Option 2️⃣ For groups of over 4+ attendees, the eligible discount is 20%. Please use this code at checkout: GROUP 4+ Where do I add the discount code?
Course Information Join us for a comprehensive refresher focusing on crucial Good Laboratory Practice (GLP) requirements, including an emphasis on data integrity, recent developments, and emerging trends gleaned from MHRA inspections. The programme dives into specific domains such as risk assessment, OECD guidance on sponsor influence, and the advisory from OECD on QA. Additionally, delegates can benefit from a dedicated GLP clinic, facilitating discussions on understanding and upholding GLP compliance. Is this course for you? This course is tailored for study directors, principal investigators, test facility management, and QA professionals seeking to refresh their knowledge and responsibilities within the GLP framework. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Registration, Welcome and Introduction 09:20 Development of Good Laboratory Practice A reminder of the history of GLP, its current scope and application, with a synopsis of current UK, European and international standards. 09:50 Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA A reminder of the roles and responsibilities with regard to the GLP management and oversight of the Test Facility and the management and control of the study, as defined by GLP. 10:30 Break 10:45 Workshop 1 Workshop 1 Roles and responsibilities 11:15 Influence of Sponsors The published OECD Position Paper No. 21 regarding Possible Influence of Sponsors on conclusions of GLP Studies is reviewed and discussed. 11:45 Data Integrity The fundamentals of data integrity according to the OECD Guidance No. 22 on Data Integrity is discussed along with the responsibilities of Study Director, Test Facility Management, and study staff in ensuring the integrity of the GLP study data. 12:30 Lunch 13:15 Quality Assurance and GLP OECD Advisory No. 23 (Revision of OECD No.4)- A walk through of the changes to the OECD Guidance on the role and activities of Quality Assurance 13:45 Quality Improvement Tools and GLP The tools that might be considered for GLP and their role and operation when used in Test Facilities- OECD Position Paper No.24 published July 2022 14:15 Workshop 2 Workshop 2 Change control 14:30 Risk Assessment How should we assess risk and how can we use the process to assist in evaluation audit findings? 15:00 Break 15:15 Current hot topics in GLP Explore the current issues in Industry and trends /types of Regulatory inspection findings 15:50 GLP Clinic An opportunity to discuss any other issues regarding understanding and maintaining GLP Compliance. 16:30 Close of Course Extra Information Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 7 Points Development Level Learn