11848 Professional Development courses in Dunfermline delivered Online

Essential to validation is the provision of documented evidence verifying that manufacturing processes will consistently result in products meeting predetermined quality standards. This module describes the purpose, content and use of validation master plans, project validation plans, and other documentation for validation projects in the medicines and healthcare products industries. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.

Validation of equipment, services, systems and processes is vitally important in the medicines and healthcare products industries. Regulatory authorities require documented evidence that manufacturing processes will consistently result in products meeting predetermined quality standards. This module provides an introduction to validation and to the regulations and guidance that apply to it. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.

This module outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.

Changes to the terms of marketing authorisations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the composition of products, their manufacturing processes, the way they are used, or the indications for which they are authorised. Common approaches are adopted within the European Economic Area to variations to marketing authorisations approved through the Centralised, Decentralised or Mutual Recognition Procedures. Recent legislation has substantially modified the regulatory requirements and extended them to purely national authorisations by member states. This module, which is fully up to date with the new legislation, covers the classification of variations into their several types and the regulatory requirements, guidance and procedures to be followed for each type.

The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.

Having undergone Installation Qualification, before equipment can be used routinely in production, it needs to undergo Operational Qualification (OQ) and Performance Qualification (PQ). This module describes OQ and PQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.

Before equipment can be used routinely in production, it must first be commissioned and, if necessary, undergo Installation Qualification (IQ). This module describes commissioning and IQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed.

Get ready for an exceptional online learning experience with the Import-Export: Supply Chain Management bundle! This carefully curated collection of 20 premium courses is designed to cater to a variety of interests and disciplines. Dive into a sea of knowledge and skills, tailoring your learning journey to suit your unique aspirations. The Import-Export: Supply Chain Management is a dynamic package, blending the expertise of industry professionals with the flexibility of digital learning. It offers the perfect balance of foundational understanding and advanced insights. Whether you're looking to break into a new field or deepen your existing knowledge, the Supply Chain Management package has something for everyone. As part of this package, you will receive complimentary PDF certificates for all courses in this bundle at no extra cost. Equip yourself with the Supply Chain Management bundle to confidently navigate your career path or personal development journey. Enrol today and start your career growth! This Bundle Comprises the Following CPD Accredited Courses: Import/Export Logistic Management Supply Chain Management Certificate in Purchasing and Procurement Purchase Ledger Operations Management: Process Mapping & Supply Chain Commercial law Transport Manager Port Management Diploma Diploma in Lean Process and Six Sigma Retail Management Product Management Commercial Management SAP Controlling (CO) - Product Costing S4HANA Compliance and Risk Management Diploma Career Development Plan Fundamentals CV Writing and Job Searching Learn to Level Up Your Leadership Networking Skills for Personal Success Ace Your Presentations: Public Speaking Masterclass Learning Outcome: Gain comprehensive insights into multiple fields. Foster critical thinking and problem-solving skills across various disciplines. Understand industry trends and best practices through the Supply Chain Management Bundle. Develop practical skills applicable to real-world situations. Enhance personal and professional growth with the Supply Chain Management Bundle. Build a strong knowledge base in your chosen course via thisBundle. Benefit from the flexibility and convenience of online learning. With the Supply Chain Management package, validate your learning with a CPD certificate. Each course in this bundle holds a prestigious CPD accreditation, symbolising exceptional quality. The materials, brimming with knowledge, are regularly updated, ensuring their relevance. This bundle promises not just education but an evolving learning experience. Engage with this extraordinary collection, and prepare to enrich your personal and professional development. Embrace the future of learning with the Import-Export: Supply Chain Management, a rich anthology of 15 diverse courses. Each course in the Supply Chain Management bundle is handpicked by our experts to ensure a wide spectrum of learning opportunities. ThisImport-Export: Supply Chain Management bundle will take you on a unique and enriching educational journey. The bundle encapsulates our mission to provide quality, accessible education for all. Whether you are just starting your career, looking to switch industries, or hoping to enhance your professional skill set, this bundle offers you the flexibility and convenience to learn at your own pace. Make the Supply Chain Management package your trusted companion in your lifelong learning journey. CPD 200 CPD hours / points Accredited by CPD Quality Standards Who is this course for? The Import-Export: Supply Chain Management bundle is perfect for: Lifelong learners looking to expand their knowledge and skills. Professionals seeking to enhance their career with CPD certification. Individuals wanting to explore new fields and disciplines. Anyone who values flexible, self-paced learning from the comfort of home. Career path Unleash your potential with the Import-Export: Supply Chain Management bundle. Acquire versatile skills across multiple fields, foster problem-solving abilities, and stay ahead of industry trends. Ideal for those seeking career advancement, a new professional path, or personal growth. Embrace the journey with the Import-Export: Supply Chain Management bundle package. Certificates Certificate Of Completion Digital certificate - Included Certificate Of Completion Hard copy certificate - Included You will get a complimentary Hard Copy Certificate.