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Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.

The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for marketing and sale in the USA.

This module describes the design, development and installation phase, the validation phase, and the operation and maintenance phase of the validation of computerised systems in medicines and healthcare products manufacturing environments. It continues to follow the progress of a pharmaceutical company's project to validate a new dispensary control system.

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.

Manufacturers of medicines and healthcare products must establish, validate and maintain an equipment cleaning programme. This is a regulatory requirement because validated cleaning procedures contribute to the assurance of product purity and safety. This module provides a comprehensive account of equipment cleaning validation requirements and procedures. It follows the work of a pharmaceutical company's validation team as they establish and validate the cleaning program 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.

Overview: Give a compliment to your career and take it to the next level. This Pharmacy Assistant & Pharmacy Technician bundle will provide you with the essential knowledge to shine in your professional career. Whether you want to develop skills for your next job or elevate your skills for your next promotion, this Pharmacy Assistant & Pharmacy Technician bundle will help you stay ahead of the pack. Throughout the Pharmacy Assistant & Pharmacy Technician programme, it stresses how to improve your competency as a person in your chosen field while also outlining essential career insights in the relevant job sector. Along with this course, you will get 10 premium courses, an original hardcopy, 11 PDF certificates (Main Course + Additional Courses) Student ID card as gifts. This Pharmacy Assistant & Pharmacy Technician Bundle Consists of the following Premium courses: Course 01: Pharmacy Assistant & Pharmacy Technician Course 02: Pharmacy Dispenser Course 03: Control and Administration of Medication Diploma Level 3 Course 04: Safety & Precautions in Medication Management Course 05: Infection Control & Medicine Handling Course 06: Safe Handling of Medicines Course 07: Nurse Prescribing Diploma Course 08: Medication Training Course 09: Diploma in Alternative Medicine Training Course 10: Medical Secretary Diploma Course 11: Paramedicine Study Course 12: Biomedical Science Course 13: Laboratory Technician Course 14: Sports Medicine Fundamentals Course 15: Food as Medicine Course 16: Medical Law Course 17: Introduction to Medical Terminology Course 18: Medical Writing Course 19: Medical Transcription: Audio Typist Course 20: Certificate in Risk Assessment and Health Care at QLS Level 3 Enrol now in Pharmacy Assistant & Pharmacy Technician to advance your career, and use the premium study materials from Apex Learning. Description: The Pharmacy Assistant & Pharmacy Technician bundle incorporates basic to advanced level skills to shed some light on your way and boost your career. Hence, you can strengthen your Pharmacy Assistant & Pharmacy Technician 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. ★★★ Course Curriculum of Pharmacy Assistant & Pharmacy Technician Bundle ★★★ Course 01: Pharmacy Assistant & Pharmacy Technician Module 01: Introduction Module 02: Job Role Module 03: Patient Counselling Guide Module 04: Communication Module 05: The Pharmacy Team and Practices Module 06: Prescription and Dispensing in Pharmacies Module 07: Dispensing Methods, EPS, Minimising Dispensing Errors in Pharmacies Module 08: Inventory Control and Management in Pharmacies Module 09: Standard Operating Procedures (SOPs) Module 10: Health and Safety Risks Assessment and Pharmaceutical Terminology ---------- And 10 More Courses ---------- How will I get my Pharmacy Assistant & Pharmacy Technician Certificate? After successfully completing the Pharmacy Assistant & Pharmacy Technician course, you will be able to order your CPD Accredited Certificates (PDF + Hard Copy) as proof of your achievement. PDF Certificate: Free (Previously it was £9.99*20= £199) Hard Copy Certificate: Free (For The Title Course: Previously it was £14.99) So, enrol now in this Pharmacy Assistant & Pharmacy Technician Bundle to kickstart your career! Who is this course for? Anyone from any background can enrol in this Pharmacy Assistant & Pharmacy Technician bundle. Requirements This Pharmacy Assistant & Pharmacy Technician course has been designed to be fully compatible with tablets and smartphones. Career path Having this expertise will increase the value of your CV and open you up to multiple job sectors. Certificates Digital certificate - Included Hardcopy certificate - Included

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.