3345 Courses

Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. 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. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. 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 14 Points Development Level Develop

Emotional Intelligence: In-House Training Emotional Intelligence is a set of emotional and social skills that collectively establish how well we: Perceive and express ourselves Develop and maintain social relationships Cope with challenges Use emotional information in an effective and meaningful way It is a skill set that transfers across all categories of relationships. It is also a predictor of success - both in life and at work. This highly-interactive course delivers a practical approach to developing, improving, and sustaining effective and mutually beneficial relationships. The design of the course involves individual reflection and paired activities, interwoven with small and large group interactions. The EQ-i 2.0® assessment reports will be debriefed over the course of the two days. In addition, participants will delve into their personal strengths and blind spots, and will explore topics including: the neuroscience of emotion, the connection between empathy and performance, and how communication styles impact our perceptions of self and other. Role-play activities give participants the opportunity to try out new behaviors and techniques. The program includes: A personal behavioral profile, the results of which you will bring to your training 2-day highly interactive workshop and experiential learning Optional professional coaching activities initiated in class that can continue over the four months after class ends What you will Learn Recognize your interpersonal strengths and potential blind spots regarding Emotional Intelligence Identify the five domains within the EQ-i 2.0 assessment model Summarize what neuroscience research has discovered about emotions and actions Recognize ways that human beings are physiologically impacted by stress Articulate ways to develop and maintain strong working relationships Describe how emotional intelligence translates into high performance Make use of the EI model and associated competencies Employ strategies for enhancing leadership through Emotional Intelligence Foundation Concepts The biology of emotion Why Emotional Intelligence matters The impact of EI on performance The EQ-I 2.0 Model Overview of the EQ-i 2.0 framework Exploring your report Balancing your EI domains Self: Awareness and Sensitivity Self-awareness and empathy Perception vs. reality Acting by choice, not impulse Other: Communication and Relationship-Building Elements of effective communication Communication styles Communication techniques Neuroscience and Behavioral Change Insights from social neuroscience Making a change

Conflict Resolution Skills: In-House Training Many organizations have assumed that workplace conflict is always destructive. So, they have often believed that conflict is best dealt with by managers or even via policies and procedures. After all, conflict creates workplace stress and leads to many performance problems, generating very real organizational costs! However, savvy organizations have embraced the fact that when conflict is understood and harnessed, it can be leveraged to add value to teams and even enhance performance. With the right knowledge, skills, training, and practice, conflict can be productive and make organizations better! In this highly interactive course, learners will discover the connection between individual conflict response and team-empowering conflict resolution skills. Participants will explore conflict's visceral dynamics and the nuanced behaviors we individually engage in to communicate and respond to conflict. Learners will apply techniques for transforming unproductive conflict responses into productive ones. Additionally, learners will use a systematic method that prepares them to objectively dissect real-world conflict, while practicing many strategies for resolving it. They will also develop proactive conflict approach plans, which they can transfer back to their own workplaces. What you will Learn At the end of this program, you will be able to: Recognize the organizational costs of conflict Explain our physical and mental responses to conflict Communicate proactively and effectively with different types of people during conflict Replace unproductive conflict responses with productive ones Use the Conflict Resolution Diagram (CRD) process and conflict resolution approaches Relate team stages of development to shifts in conflict Develop a proactive conflict approach for your organization Create a conflict resolution plan for a real-world scenario Getting Started Introductions and social agreements Course goal and objectives Opening activities Conflict Facilitation Readiness Conflict responses and perceptions Conflict basics Conflict and organizations Dynamics of conflict Conflict Styles and Communication A look at the color energies model Conflict through the color energies and DiSC® lens Communication with opposite color energies Individual Response to Conflict The anatomy of conflict Recognizing unproductive conflict responses 4 steps to productive conflict Choosing productive conflict responses Team Performance and Conflict High-performing team relationships Conflict and project team performance Conflict Resolution Diagram (CRD) and process Conflict Facilitation - Preparation Recognizing context and stakeholder needs Using team conflict resolution approaches Preparing for Crucial Conversations® Conflict Facilitation - Clarity Exposing assumptions and biases Defining the conflict and using the CRD Conflict Facilitation - Action Proactive conflict management Conflict facilitation practice Summary and Next Steps Review Personal action plans

In this course, students will learn general strategies for planning, designing, developing, implementing, and maintaining an IoT system through various case studies and by assembling and configuring an IoT device to work in a sensor network.

Communication Skills 1 Day Training in Crewe

Gain comprehensive knowledge and practical skills in seizure first aid and rectal paraldehyde administration with our course. Ideal for caregivers, healthcare professionals, educators, and individuals.

IPv6 demystified training course description IPv6 is the next generation Internet Protocol. This course looks at the benefits and features of the new protocol along with an assessment of the likely impact of the protocol and migration strategies. What will you learn Explain the benefits and disadvantages of IPv6 Recognise the impact of IPv6 on existing networks. Plan migration strategies for IPv6 Integrate IPv6 and IPv4 networks IPv6 demystified training course details Who will benefit: Sales staff, managers and other non technical staff. Prerequisites: None. Duration 1 day IPv6 demystified training course contents What's wrong with IPv4 IPv4 works, NAT, carrier grade NAT, addresses running out. Current state of IPv4 addressing. Why IPv6 Reasons for IPv6, what is IPv6? the origins of IPv6. IPv6 addressing IPv6 address allocation, address format, prefixes, address categories, scope zones, global unicast, link local. Plug and play. Migration techniques A migration plan, Dual stack, DNS, tunnelling, tunnel establishment, tunnel brokers, Tunnel types. IPv6 steps How IPv6 can affect the following: Firewalls, routers, switches!, DNS, Web services, Email. Current state of IPv6 IPv6 release 1996, 3G, World IPv6 day 2011, World IPv6 launch 2012.

Our classroom training provides you the opportunity to interact with instructors and benefit from face-to-face instruction. For more queries, reach out to us: info@mangates.com

Our classroom training provides you the opportunity to interact with instructors and benefit from face-to-face instruction. For more queries, reach out to us: info@mangates.com

Our classroom training provides you the opportunity to interact with instructors and benefit from face-to-face instruction. For more queries, reach out to us: info@mangates.com