10632 Professional Development courses in Peterlee delivered On Demand

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.

Recognised Accreditation This course is accredited by continuing professional development (CPD). CPD UK is globally recognised by employers, professional organisations, and academic institutions, thus a certificate from CPD Certification Service creates value towards your professional goal and achievement. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. What is CPD? Employers, professional organisations, and academic institutions all recognise CPD, therefore a credential from CPD Certification Service adds value to your professional goals and achievements. Benefits of CPD Improve your employment prospects Boost your job satisfaction Promotes career advancement Enhances your CV Provides you with a competitive edge in the job market Demonstrate your dedication Showcases your professional capabilities What is IPHM? The IPHM is an Accreditation Board that provides Training Providers with international and global accreditation. The Practitioners of Holistic Medicine (IPHM) accreditation is a guarantee of quality and skill. Benefits of IPHM It will help you establish a positive reputation in your chosen field You can join a network and community of successful therapists that are dedicated to providing excellent care to their client You can flaunt this accreditation in your CV It is a worldwide recognised accreditation What is Quality Licence Scheme? This course is endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Benefits of Quality License Scheme Certificate is valuable Provides a competitive edge in your career It will make your CV stand out Course Curriculum Solid Waste Management Introduction 00:02:00 Setting the context 00:07:00 Classifying waste 00:08:00 Components of waste management 00:09:00 Best Practices 00:14:00 Targeting zero waste 00:14:00 Assessment Assessment - Solid Waste Management Fundamentals 00:10:00 Certificate of Achievement Certificate of Achievement 00:00:00 Get Your Insurance Now Get Your Insurance Now 00:00:00 Feedback Feedback 00:00:00

Recognised Accreditation This course is accredited by continuing professional development (CPD). CPD UK is globally recognised by employers, professional organisations, and academic institutions, thus a certificate from CPD Certification Service creates value towards your professional goal and achievement. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. What is CPD? Employers, professional organisations, and academic institutions all recognise CPD, therefore a credential from CPD Certification Service adds value to your professional goals and achievements. Benefits of CPD Improve your employment prospects Boost your job satisfaction Promotes career advancement Enhances your CV Provides you with a competitive edge in the job market Demonstrate your dedication Showcases your professional capabilities What is IPHM? The IPHM is an Accreditation Board that provides Training Providers with international and global accreditation. The Practitioners of Holistic Medicine (IPHM) accreditation is a guarantee of quality and skill. Benefits of IPHM It will help you establish a positive reputation in your chosen field You can join a network and community of successful therapists that are dedicated to providing excellent care to their client You can flaunt this accreditation in your CV It is a worldwide recognised accreditation What is Quality Licence Scheme? This course is endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Benefits of Quality License Scheme Certificate is valuable Provides a competitive edge in your career It will make your CV stand out Course Curriculum Introduction Introduction to Overhead, Direct and Indirect Costs and Allocation Methods 00:03:00 Overhead Cost 00:06:00 Understanding Overhead Rates and Allocation Methods 00:29:00 Summary 00:14:00 Supplementary Resources Supplementary Resources - The Controllership Series: Overhead, Direct and Indirect Costs and Allocation Methods 00:00:00 Obtain Your Certificate Order Your Certificate of Achievement 00:00:00 Get Your Insurance Now Get Your Insurance Now 00:00:00 Feedback Feedback 00:00:00