4462 Professional Development courses

Level 7 Diploma (FREE QLS Endorsed Certificate)| 11 CPD Courses+11 PDF Certificate| 150 CPD Points| CPD & CiQ Accredited

Level 5 Diploma(FREE QLS Endorsed Certificate)| 11 CPD Courses+11 PDF Certificates| 140 CPD Points|CPD & CiQ Accredited

Level 5 QLS Endorsed Diploma | 150 CPD Points | +Gifts: QLS Certificate + PDF Certificate | 24/7 Learner Support

This course is suitable if you work or want to work as a teacher/trainer/tutor in Further Education Colleges, adult and community education, the voluntary sector, commerce, industry, the public sector or HM forces.

Level 5 QLS Endorsed Diploma | 150 CPD Points | +Gifts: QLS Certificate + PDF Certificate | 24/7 Learner Support

THE 9 STEPS TO SALES P.O.T.E.N.T.I.A.L - INTERACTIVE WORKSHOP It's time to take charge of your sales process. You need a framework that empowers you rather than binds you to their approach. THEIRS - Send me a propsal with you best ideas, processes and price and then I'll disappear. The 9 Steps is a tried and tested process that keeps you in control of the sales conversation and ensures you achieve clear and specific outcomes. I am running a one-hour interactive session, which will be followed 2 weeks later with a one-hour feedback session. Here, you can share your experiences using the process in an open forum and gain further insights.

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.

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.

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.

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.