Course Information A must-have programme for Quality Assurance auditors stepping into or honing their role within a Good Laboratory Practice (GLP) environment, this course offers invaluable, expert guidance for crafting a robust and efficient GLP audit programme. What will I learn? A solid regulatory foundation underpinning quality assurance activities Clarity on the roles of Quality Assurance, management, and study director within the framework of Good Laboratory Practice principles Enhanced efficacy in inspections and audits Heightened compliance with Good Laboratory Practice standards for your facility Unique insights into governmental monitoring activities within the GLP sphere. This course is structured to encourage delegates to Discuss and develop ideas Solve specific problems Examine particular aspects of GLP. Tutors Tutors will be comprised of (click the photos for biographies): Cate Ovington Director, The Knowlogy Group Ltd Jane Elliston Senior Quality Assurance Auditor, Battelle UK Shona Ross Head of QA, Tower Mains Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:15 Good Laboratory Practice Standards and Regulations An insight into the background and history of Good Laboratory Practice. 09:45 Principles of Quality Assurance What is the role and responsibilities of QA in GLP. Maintaining the independence of QA and what is an audit. 10:30 Break 10:45 Standard Operating Procedures GLP requirements and QA involvement. 11:30 Study Plans GLP requirements and QA involvement. 12:05 QA Programme Risk based programme, what are study, process and facility audits. 13:00 Lunch 14:00 Inspections Attitudes, techniques and attributes. 14:40 Workshop 1 - Facility and Process Inspections An exercise in inspection planning and preparation for inspections. 15:15 Break 15:30 Workshop 1 - Feedback 15:45 The Auditor and Audit Conduct Attitudes, attributes and techniques. 16:30 Panel Session An opportunity for delegates to put questions to the panel of speakers. 17:15 Close of Day Day 2 09:00 Workshop 2 - A Mock Audit 10:45 Break 11:00 Workshop 2 - Feedback 11:30 Auditing the Study Report Techniques and methods for the QA audit of the study report. 12:00 Record Keeping and Data The impact of GLP on data and records management. 12:40 Lunch 13:25 Data Integrity A look at the OECD GLP guidance document; the expectations of the regulators and the involvement of QA - Where QA adds value. 14:15 Workshop 3 - Amendments to Study Plan and Deviations from the Plan What are they? What is the difference between them? How are they controlled? 15:00 Workshop 3 - Feedback 15:15 Break 15:30 Regulatory Compliance GLP Monitoring Authority monitoring for compliance with Good Laboratory Practice. 16:15 Panel Session An opportunity for delegates to put questions to the panel of speakers. 16:45 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 Learn
Course Objectives At the end of this course you will be able to: Work with advanced lookup and reference functions Create macros to automate common tasks Use advanced techniques to analyse data Create PivotTables and PivotCharts Work with data validation tools Import and export data ' Customer Feedback Best Training Ever! Just finished a bespoke 1-1 training course in Excel Advanced, Macros & VBA. Pedro is an excellent trainer, imparting his skills and knowledge in the best way - appropriately to audience skills, knowledge and ability. Pedro is always approachable, encouraging and supportive, giving delegates the optimum learning environment. I would not hesitate to recommend Pedro as a trainer, whatever your level of ability. Amanda Morris - Treasury & Systems Accountant at Reall - Real Equity for All The course was very interesting and engaging and will definitely be put to use. The trainer was very helpful and charismatic. Marving Lopez - AM Best Europe Pedro was excellent. Very knowledgeable, clear and great rapport with class. Darren Barkey - Direct Wines Great content and learnt a lot. Really enjoyable :) Kristie-Lee Ryan - Stirling Ackroyd 1 year email support service Take a closer look at the consistent excellent feedback from our growing corporate clients visiting our site ms-officetraining co uk With more than 20 years experience, we deliver courses on all levels of the Desktop version of Microsoft Office and Office 365; ranging from Beginner, Intermediate, Advanced to the VBA level. Our trainers are Microsoft certified professionals with a proven track record with several years experience in delivering public, one to one, tailored and bespoke courses. Our competitive rates start from £550.00 per day of training Tailored training courses: You can choose to run the course exactly as they are outlined by us or we can customise it so that it meets your specific needs. A tailored or bespoke course will follow the standard outline but may be adapted to your specific organisational needs. Please visit our site (ms-officetraining co uk) to get a feel of the excellent feedback our courses have had and look at other courses you might be interested in. Advanced Functions COUNT, COUNTA, COUNTIF, COUNTBLANK, SUMIF, SUBTOTAL IF, OR, AND, IFERROR VLOOKUP to lookup Exact Values and Approximate values MATCH, INDIRECT, ROW/COLUMN, INDEX, OFFSET Analysing Data PMT function to calculate a monthly payment of a loan What If Analysis using Goal Seek Use scenarios to consider many different variables Using Solver Add-in to optimize variables PivotTables Create a PivotTable to analyse worksheet data Add or remove fields in a PivotTable Change the data source for a PivotTable Working with external data sources Using different Statistical Functions Calculate a Running Total, % of Grant Total, Difference From… Using the Slicer and Timeline to filter the PivotTable Using Filters in a PivotTable Group by Date, Auto Group by ranges of values, Custom Group Create a PivotChart The GETPIVOTDATA function Formula auditing Precedents and dependents Error checking Watch a formula and its result by using the Watch Window Evaluate a nested formula one step at a time Data Validation Number Validation Data List Validation Message Prompts and Alerts Conditional Data Validation Data Validation Errors Consolidation Consolidate data by position Consolidate data by category Use a formula to consolidate data Outline (group) data in a worksheet Create an outline of rows Create an outline of columns Copy outlined data Hide or remove an outline Connect external data to your workbook Using the Power Query Editor to import data From Text and CSV, From Access, From Web, From another Workbook Using the Power Query Editor to; Transform your data by Selecting which fields to import, by Splitting Columns, Changing Data Type and more. Deleting Applied Steps Refreshing your data Working with Form Controls; Buttons, Option Buttons and Scroll Bars Introduction to Macros Change Macro Security settings How to Record a macro Some Macro Examples Delete a macro Edit the macro to view the VBA code Copy part of a macro to create another macro Assign a macro to a button Who is this course for? Who is this course for? This course is intended to end users who want to develop their skills so they can use advanced techniques to analyse extensive and complex datasets in Excel and to automate simple tasks with the use of Macros. Requirements Requirements Preferably, delegates should have attended the Excel Intermediate course. Career path Career path Excel know-how can instantly increase your job prospects as well as your salary. 80 percent of job openings require spreadsheet and word-processing software skills Certificates Certificates Certificate of completion Digital certificate - Included
Employee Assistance Programme Training
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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.
In this Training we look at how to: Create a culture of Belonging from a team members very first day. How to create a diverse environment to help everybody connect. How to keep everybody connected when team members change.
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