126 Good Manufacturing Practice (GMP) courses

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This Industrial Engineering: Project Management, Certified Scrum Master & Lean Six Sigma - 30 in 1Bundle Comprises the Following CPD Accredited Courses: Course 01: Project Management Course 02: Agile Scrum Master Certification Course 03: Advance Lean Six Sigma Black Belt Course Course 04: Complete Lean Six Sigma Green Belt Course for Service Industry Course 05: Lean Six Sigma White Belt course Course 06: Good Manufacturing Practice (GMP) Course 07: Process Improvement Course 08: Process Mapping: Toolkit Course 09: RCA: Root Cause Analysis Course 10: Hands on Training on Production Management Course 11: Quality Management and Strategic Training - ISO 9001 Course 12: Rapid Business Improvement Course 13: Energy Engineer Course Course 14: Financial Analysis Course 15: Corporate Finance: Profitability in a Financial Downturn Course 16: Banking and Finance Accounting Statements Financial Analysis Course 17: Capital Budgeting & Investment Decision Rules Course 18: Quality Management Course 19: Leadership and Management Course Course 20: Change Management Course 21: Facilities Management Diploma Course 22: Operations Management Course 23: Supply Chain Management Course 24: Logistic Management Course 25: Certificate in Purchasing and Procurement Course 26: Corporate Risk And Crisis Management - Online Course Course 27: Level 2 Health and Safety in the Workplace Course 28: Decision-Making and Critical Thinking Course 29: Ace Your Presentations: Public Speaking Masterclass Course 30: Learn to Make a Fresh Start in Your Life What will make you stand out? 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Packaging for medicinal products is subject to Good Manufacturing Practice rules similar to those for the products themselves. In this module we describe the functions that packaging must fulfil and the quality controls that are applied to packaging materials and operations. We set out the requirements for control of printed materials. We describe preparation, in-process control, and completion of a packaging run. Finally, we explain how to carry out reconciliation of packaging materials.

Course Information Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process. Extending Expertise: Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning. Relevance and Value: Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course.  Key Benefits: Enrich your skill set to: Navigate audit processes encompassing planning, execution, reporting, and follow-up Embrace a personalised approach fostering positive audit outcomes Analyse evidence and present cohesive audit findings Recognise the pivotal role of audits in driving continual improvement. Interactive Learning: Structured to foster dynamic engagement, this course encourages delegates to: Engage in discussions, idea development, and problem-solving Exchange invaluable information and experiences. Hands-On Experience: A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios. Tutors Tutors will be comprised of (click the photos for biographies): Andrew Waddell Founder Director, Tower Mains Ltd Rosemary Ichaba Senior QA Associate, Tower Mains Ltd Cate Ovington Director, The Knowlogy Group Ltd Jean McWilliam Associate Director, Alexion View pop up Programme Please note timings may be subject to alteration. Day 1 08:45 Registration 09:00 Welcome and Course Objectives 09:10 What is 'Audit'? Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements. 09:30 Audits and their Purpose The concepts of quality assurance, quality control, quality management and audit are discussed. 10:30 Break 10:45 Audit Planning The requirements for an effective audit programme and individual audit plans. 11:30 Workshop 1 - Getting the Audit Started Planning for the audit. 12:25 Workshop 1 - Feedback 12:45 Lunch 13:30 Workshop 2 - Getting the Audit Started Arranging the opening meeting. 13:50 Workshop 2 - Feedback Audit initiation. Review and discussion of the role of the opening meeting. 14:25 Auditing Techniques (1) - Data and Documentation Techniques for the conduct of data and report audits are investigated. 14:55 Break 15:10 Workshop 3 - Data and Documentation Audit Conducting an audit of a data package and supporting documentation. 17:15 Close of Day Day 2 09:00 Auditing Techniques (2) - The People Questioning techniques which get the required information from the auditee. 09:45 Live Audit Role Play Auditor and auditee behaviours are explored and strategies developed for successful audit interactions. 10:15 Break 10:35 Audit Closing Meeting An exploration of audit closing meetings. 11:00 Workshop 4 - Audit Observations and Preparing for the Closing Meeting Reviewing and categorising your observations and getting ready to present your case. 11:45 Workshop 4 - Feedback 12:30 Audit Reports The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed. 13:00 Lunch 13:45 Workshop 5 - Audit Reports and Follow-up Mechanisms for promoting effective corrective and preventive action. Critical review of an audit report example. 14:30 Workshop 5 - Feedback 14:55 Corrective and Preventive Action and Follow-up The auditor's role in monitoring responses to audit and the corrective and preventive actions promised is explored. 15:20 Panel Session An opportunity to get answers to outstanding questions. 15:30 Close of Course Extra Information 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. CPD Points 14 Points   Development Level Develop

Has the Computer System Validation Engineer left and you’ve been handed their responsibilities? Do the thoughts of your next audit fill you with dread? CSV can be frustrating but this program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework and ensure compliance with FDA’s 21 CFR Part 11, EU Annex 11 or other regulatory guidelines.

In the medicines and healthcare products industries, computerised systems used in automated manufacturing or laboratory processes to which Good Manufacturing Practice requirements apply need to be validated. This module describes the planning of such validation. It follows the work of a pharmaceutical company's team as they validate the dispensary control system for a new production line.

Average entry-level pharma roles pay 96% of NHS Band 5 and come with opportunities for overtime, shift allowance and additional benefits as well as huge scope for career progression and salary increases.

Take our part-time online “Conversion Course into Pharmaceutical Manufacturing“ NO Previous Industry Experience or Science Qualifications Required

Course Information Join us for a two-day immersive course crafted to equip participants with an in-depth understanding of remote audit methodologies. Delve into the nuances between remote and face-to-face audits, dissecting their respective strengths and limitations. Through practical scenarios tailored for remote audit conduct, this course stands as an essential counterpart to our on-site audits course The Auditing Course. Who Should Attend: Applicable across various domains of regulated research and development, this course proves invaluable in contexts requiring a quality system for audit. Participants with firsthand audit experience stand to gain the most benefit from this programme. Expanding on Previous Learning: This course extends its relevance to all forms of audits and further amplifies concepts explored in RQA's suite of research quality assurance courses, including: 'Research Quality Assurance for Good Laboratory Practice,' 'Good Clinical Practice Auditing – Principles and Practice,' and 'Good Manufacturing Practice for Investigational Medicinal Products.' Benefits include improved: Understand the processes of planning, conducting, reporting and follow-up of audits Recognising the importance of personal approach in developing positive audit outcomes Ability to analyse evidence and present logical audit findings Appreciate the importance of audit in continuing improvement. This course is structured to encourage delegates to: Discuss and develop ideas Solve problems Exchange information. Tutors Tutors will be comprised of (click the photos for biographies): Andrew Waddell Founder Director, Tower Mains Ltd Rosemary Ichaba Senior QA Associate, Tower Mains Ltd Cate Ovington Director, The Knowlogy Group Ltd Jean McWilliam Associate Director, Alexion Programme Please note timings may be subject to alteration. Day 1 09:00 Course Registration 09:15 Welcome and Introductions 09:35 Introduction to Audits Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements. 10:05 Introduction to Remote Audits Presentation to introduce the major differences between face-to-face audits and remote audits. The major elements of audits will be examined to determine where there may be differences. 10:30 Break 10:45 Workshop 1 - Remote Audits This workshop will examine participants experience or understanding of the differences between face-to-face and remote audits. 11:15 Workshop 1 - Feedback 11:35 Audit Preparation The essential steps in preparation for audits will be discussed with emphasis on remote audits. 12:05 Workshop 2 - Remote Audit Preparation Factors relating to the preparation for remote audits will be considered in discussion groups. 12:35 Workshop 2 - Feedback 12:50 Lunch 13:30 Audit Logistics Preparation for the audit includes many arrangements other than the audit content. 14:00 Workshop 3 - Audit Logistics Delegates will discuss some of the issues that may occur during the set up and conduct of remote audits and how to resolve them. 14:30 Workshop 3 - Feedback 14:45 Break 15:00 The Opening Meeting Presentation regarding the importance and content of the opening meeting. 15:20 Workshop 4 - Opening Meeting Delegates will consider the practicalities of arranging and conducting an opening meeting. 15:45 Workshop 4 - Feedback 16:10 Audit Conduct Tools Practical advice on preparation of some of the tools that will be valuable in the conduct of audits. 16:40 Questions and Answers An overview of the first day and a chance to ask questions 17:00 Close of Day Day 2 09:00 Reflections on Day 1 Recap on the topics covered and a chance for delegates to raise points. 09:15 Gathering Evidence Presentation on challenges of gathering evidence and conducting interviews during remote audits. 09:45 Workshop 5 - Remote Interviews Scenarios of different remote interviews will be played and delegates assess the strengths and weaknesses of each approach. 10:15 Break 10:30 Creating Audit Findings Ideas regarding how to create good audit findings will be discussed during this short presentation. 10:50 Workshop 6 - Creating Audit Findings Delegates will be provided with examples of evidence from an audit. They will discuss these and create their audit findings for presentation at the closing meeting. 11:35 The Closing Meeting The content and conduct of the closing meeting will be discussed. 11:55 Workshop 7(a) - Preparing for the Closing Meeting The findings from workshop 6 will be reviewed and a Lead Auditor selected to provide feedback in workshop 7(b) 12:15 Workshop 7(b) - The Closing Meeting The Lead Auditor from each group will hold a meeting to present the results (role play). 12:45 Lunch 13:30 The Audit Report This presentation will cover not only the essential contents of the audit report but also how to write the report in a manner that will generate the most positive reaction. 14:00 Workshop 8 - The Audit Report Delegates will be provided with an audit report from an audit conducted remotely and will conduct a peer review of the report in their breakout groups. 15:00 Workshop 8 - Feedback 15:20 Break 15:35 Audit Closure Presentation on how to conclude the audit with reference to post-audit activities. 15:55 Open Forum 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.