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2149 Professional Development courses in Nottingham delivered On Demand

VAL01: Introduction to Validation

By Zenosis

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.

VAL01: Introduction to Validation
Delivered Online On Demand1 hour 30 minutes
£99

SUB13: How to Gain Approval to Market a Generic Drug in the USA

By Zenosis

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.

SUB13: How to Gain Approval to Market a Generic Drug in the USA
Delivered Online On Demand3 hours
£99

SUB06: Variations to Marketing Authorisations in Europe

By Zenosis

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.

SUB06: Variations to Marketing Authorisations in Europe
Delivered Online On Demand3 hours 30 minutes
£99

SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA

By Zenosis

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.

SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA
Delivered Online On Demand30 minutes
£99

SUB15: The Biologics License Application (BLA) for Marketing Approval in the USA

By Zenosis

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.

SUB15: The Biologics License Application (BLA) for Marketing Approval in the USA
Delivered Online On Demand3 hours 30 minutes
£99

VAL04: Operational and Performance Qualification

By Zenosis

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.

VAL04: Operational and Performance Qualification
Delivered Online On Demand1 hour
£99

VAL03: Commissioning and Installation Qualification

By Zenosis

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.

VAL03: Commissioning and Installation Qualification
Delivered Online On Demand1 hour 30 minutes
£99

ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products

By Zenosis

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.

ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products
Delivered Online On Demand3 hours
£99

HR Management Essentials for Human Resources Manager

4.9(27)

By Apex Learning

Overview: Tired of searching and accumulating all the relevant courses for this specific field? It takes a substantial amount of your time and, more importantly, costs you a fortune! Well, we have just come up with the ultimate solution for you by giving this all-inclusive HR Management mega bundle. This 20 courses mega bundle keeps you up-to-date in this field and takes you one step ahead of others. Keeping in mind the latest advancements in this ever-emerging sector, the HR Management bundle covers all the state-of-the-art tools and techniques required to become a competent worker in this area. You will encounter specific courses relevant to the sector. We take you from the most introductory fundamentals to advance knowledge in a step-by-step manner. In addition, the HR Management bundle also consists of courses related to some soft skills that you will need to succeed in any industry or job sector. This HR Management Bundle consists of the following premium courses: Course 01: HR Management Course 02: HR Virtual Interview Techniques Course 03: Managing Online Meetings Course 04: Decision Making in High Stress Course 05: Supporting a Grieving Employee Course 06: Working from Home Essentials Course 07: HR Crisis Communication Training Course 08: Employment Law for HR Course 09: Administrative Management Course 10: Managing Budgets Course 11: Business Analysis Course 12: Business Ethics for the Office Course 13: Diploma in Management Skills Course 14: Goal Setting & Accomplishment Course 15: Team Management Advanced Training Course 16: Talent Management Course 17: Ethical Leadership Principles Course 18: Risk Management: Risk Assessment & Analysis Course 19: Conflict Management and Crucial Communications Course 20: Customer Relationship Management Our cutting-edge learning package offers top-notch digital aid and first-rate tutor support. You will acquire the crucial hard and soft skills needed for career advancement because this bundle has been thoroughly examined and is career-friendly. So don't overthink! Enrol today. Learning Outcomes of this HR Training Bundle: This unique HR Management mega bundle will help you to- Quench your thirst for knowledge Be up-to-date about the latest advancements Achieve your dream career goal in this sector Know the applicable rules and regulations needed for a professional in this area Acquire some valuable knowledge related to HR Management to uplift your morale Key Features of the HR Management Course: FREE HR Management CPD-accredited certificate Get a free student ID card with HR Management training (£10 applicable for international delivery) Lifetime access to the HR Management course materials The HR Management program comes with 24/7 tutor support Get instant access to this HR Management course Learn HR Management training from anywhere in the world The HR Management training is affordable and simple to understand The HR Management training is entirely online Enrol in HR Management today and start your journey towards becoming successful! Description: The bundle incorporates basic to advanced level skills to shed some light on your way and boost your career. Hence, you can strengthen your expertise and essential knowledge, which will assist you in reaching your goal. Moreover, you can learn from any place in your own time without travelling for classes. Certificates: PDF Certificate: Free for all 20 courses Hard Copy Certificate: Free (For The Title Course: Previously it was £14.99) Who is this course for? The HR Management bundle is designed to assist anyone with a curious mind, anyone looking to boost their CVs or individuals looking to upgrade their career to the next level can also benefit from the learning materials. Requirements The courses in this bundle has been designed to be fully compatible with tablets and smartphones. Career path This HR Management bundle will give you an edge over other competitors and will open the doors for you to a plethora of career opportunities. Certificates Digital certificate - Included Hard copy certificate - Included You will get the Hard Copy certificate for the title course (HR Management) absolutely Free! Other Hard Copy certificates are available for £14.99 each. Please Note: The delivery charge inside the UK is £3.99, and the international students must pay a £9.99 shipping cost.

HR Management Essentials for Human Resources Manager
Delivered Online On Demand4 days
£109

Plumber - Plumbing Training Courses

By Imperial Academy

Level 3 Diploma(FREE QLS Endorsed Certificate)| 11 CPD Courses+11 PDF Certificates| 145 CPD Points|CPD & CiQ Accredited

Plumber - Plumbing Training Courses
Delivered Online On Demand
£129