20 FDA courses

FOUR DAY ATTENDENCE AND TRAINING GUIDELINE: DAY ONE AND TWO - INTRODUCTION TO DERMAL FILLERS Day one Arrive and coffees (10.00) Registration, introduction and expectations (10.00-10.15) Structure of the training (10.15-10.30) Break (10.30-11.00) Lectures and interactive workshops / simulation (11.00 - 1230pm) Health and safety in the workplace Sharps injury and disposal The consultation process and prescriptions LUNCH (1300-1730) with a coffee break Basic life support Anaphylaxis - recognition and management Emergency kits - what it should contain and how to buy one Your doctors on call - how to contact our on call doctors for emergency advice How to use Hyalase safely - when to use it / recognise mechanism of action, how prescription in an emergency works and how to give the hyalase Practical and to include demonstration of Hyalase injection Our added benefits services for safety and convenience Day two Arrive and coffees (10.00) introduction and expectations (10.00-10.30) Structure of the training (10.30-11.00) Formal written examination covering key areas of THEORY for Dermal Filler injections: Anatomy, Physiology, Products and Complications. This will highlight early on if any important areas need to be covered in more detail for the students (11.00 - 1200) - Break for lunch - Practical session commences - (12.30 - 1800) - and in total on average we have scope for one model per 30 minutes on both of the Dermal filler days, so that’s a potential for 10 in total for a class size of maximum 4, which will give good hands on experience, as the way we train is to allow several people the opportunity to be involved with each patient - e.g. splitting into the phases of treatment, which allows the trainees to understand the concept of the treatment process. That would be - consultation, consent, marking up, readying equipment, performing the injection, providing advice and aftercare. DAY THREE AND FOUR BOTOX FOUNDATION COURSE Day three Arrive and coffees (10.00) introduction and expectations (10.00 – 10.30) Structure of the training (10.30 – 11.00) Formal written examination covering key areas of THEORY for Botox Application: Anatomy, Physiology, Products and Complications. This will highlight early on if any important areas need to be covered in more detail for the students (11.00 - 1200) - Break for lunch - Practical session commences - (12.30 - 1800) - and in total on average we have one model per 30 minutes on both the botox and days, so that’s a potential of 10 in total for a class size of 4, which will give good hands on experience, as the way we train is to allow several people the opportunity to be involved with each patient - e.g. splitting into the phases of treatment, which allows the trainees to understand the concept of the treatment process. That would be - consultation, consent, marking up, readying equipment, performing the injection, providing advice and aftercare. Day four Observed Treatment Process Examination The participants will be tested on the following key facets of safe practical care: Consultation process - rapport and understanding what the client wants Safe consent Marking and photographs Technical skill of injection Atercare provision and safety netting (eg if this happens do this / call me) 1 model will be provided for Botulinum (3 area) treatment and 1 - 2 clients for filler to ensure that each of the key anatomical areas covered are observed. Morning = Botulinum (0900 - 1230) Afternoon = Botulinum and Option Dermal fillers (1330 - 1630) Conclusion Candidates given session and refreshments and discussion regarding Case Studies and further support. (1700 - 1800)

Official BRCGS Product Safety Management course: HARPC Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather than from the applicant’s own studies. The applicant typically proposes to market a drug that is based on an approved reference product but modified in its formulation or uses. A 505(b)(2) NDA also differs from an Abbreviated New Drug Application (ANDA) for approval of a generic drug in that the applicant’s product need not be a duplicate of the reference listed drug. The 505(b)(2) pathway may be said to lie part-way between the ‘stand-alone’ NDA and generics pathways, offering a unique combination of advantages to developers. It facilitates the modification of drugs to address unmet medical needs. The 505(b)(2) application pathway accounts for about half of all new drug approvals in the USA.

Has the Computer System Validation Engineer left and you’ve been handed their responsibilities? Do the thoughts of your next audit fill you with dread? CSV can be frustrating but this program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework and ensure compliance with FDA’s 21 CFR Part 11, EU Annex 11 or other regulatory guidelines.

In this course we set out the legal framework for the regulation of advertising and promotion of prescription drugs in the USA. We identify the regulatory authorities and sources of guidance. We summarize basic requirements that advertisements and promotional labeling must meet, and we identify consequences that may follow failure to comply.

Unlike the great majority of other countries, the advertising of prescription drugs directly to consumers is permitted in the USA. Spending by drug companies on direct-to-consumer (DTC) advertising of prescription drugs has increased more than four-fold over two decades, with a dramatic increase in the number of TV ads. In addition, the Internet and social media platforms have increasingly enabled companies to engage more actively with the public.

Are you passionate about the business side of film? Do you have an entrepreneurial mindset and ambitions to pave a career in a fast-growing creative industry? The BA (Hons) Film Business & Production degree reflects current demands for professionally ready graduates equipped with the vital creative, business and entrepreneurial skills to navigate the modern film, screen and media environment.

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Course 18: SAP Controlling (CO) - Product Costing S4HANA * Become proficient in the SAP CO module, focusing on product costing. * Understand how to integrate product costing with other SAP modules. * Gain expertise in using S4HANA for advanced cost analysis. Course 19: Business Intelligence and Data Mining * Master tools and techniques for data mining and analysis. * Understand the role of business intelligence in decision-making. * Learn to transform raw data into actionable insights. Course 20: Fundamentals of Business Analysis * Grasp the core principles of business analysis. * Develop skills in requirement gathering and stakeholder management. * Understand the role of a business analyst in various industries. Course 21: Business Administration and Financial Management Level 2 Certification * Master administrative and managerial responsibilities in a business setting. * Understand financial management principles and their application. * Learn to make informed financial decisions to ensure business growth. Course 22: Business Performance Management * Understand key performance indicators (KPIs) and their relevance. * Develop strategies to monitor, evaluate, and enhance business performance. * Learn to set and achieve performance targets. Course 23: Managing Budget: Financial Statements and Money Management * Master the art of budgeting for businesses. * Understand financial statements and their importance. * Develop skills in money management to ensure financial stability. Course 24: Business Analysis Level 3 * Dive deeper into advanced methodologies in business analysis. * Master tools and software used for in-depth data analysis. * Develop strategies to integrate business analysis outcomes in decision-making processes. Course 25: Xero Accounting & Bookkeeping * Become proficient in the Xero accounting software. * Understand the nuances of bookkeeping and financial reporting using Xero. * Gain skills to optimize the software for diverse accounting needs. Course 26: Quickbooks Bookkeeping - Starting A New Company File * Master the initial setup and configuration of a new company file in Quickbooks. * Understand best practices for bookkeeping using Quickbooks. * Learn to manage and analyze financial data effectively within the platform. Course 27: Ultimate Social Media Marketing course * Understand the dynamics of various social media platforms. * Develop strategies to optimize social media marketing campaigns. * Learn to analyze and measure the effectiveness of social media campaigns. Course 28: The Business Intelligence Analyst Course * Dive deep into the role of a business intelligence analyst. * Master tools and techniques for advanced data analysis. * Understand the integration of business intelligence insight. CPD 330 CPD hours / points Accredited by CPD Quality Standards WHO IS THIS COURSE FOR? Ambitious learners who want to strengthen their CV for their desired job should take advantage of the Business Management and Administration bundle! This bundle is also ideal for professionals looking for career advancement and further enrol in: * Level 5 Diploma in business and management * Level 3 National Extended Diploma in Business * Level 3 Diploma - Business Studies * Level 3 Diploma in Business (RQF) * CMI Level 3 Diploma in Principles of Management and Leadership * Level 4 Diploma in Business and Management * Level 5 Diploma in Business and Management * Level 6 Diploma in Business Management * Level 7 Diploma - Business Management * EDI Business Management * FdA Business and Management * Level 2 Certificate in Principles of Business Administration (RQF) * Level 2 Certificate in Principles of Business Administration (VRQ) * Level 2 Certificate in Principles of Business and Administration (RQF) REQUIREMENTS To participate in this course, all you need is - * A smart device * A secure internet connection * And a keen interest in Business Management and Administration CAREER PATH * Retail Manager * IT Manager * Financial Manager * Quality Assurance Manager * Business Development Manager * Public Relations Manager * Education Administrator * Healthcare Administrator * Compliance Manager * Property Manager * Office Coordinator * Training Manager * Supply Chain Analyst * Inventory Control Specialist * Operations Coordinator * Customer Service Supervisor * Contracts Administrator * Business Operations Analyst CERTIFICATES CPDQS DIGITAL CERTIFICATE & TRANSCRIPT INCLUDED FOR THE TITLE COURSE ONLY Digital certificate - Included After studying the course materials, you will be able to take the MCQ test that will assess your knowledge. After successfully passing the test you will be able to claim One Digital Certificate & Transcript for the title course completely free of cost. The cost for additional digital certificates is •4.99 each. CPD CERTIFIED PRINTED HARDCOPY CERTIFICATE (PER UNIT) Hard copy certificate - •8 * FREE UK Delivery * International Delivery +• 10.00 The price for each Printed Hardcopy Transcript is •9.99. * FREE UK Delivery * International Delivery +• 10.00 Student ID Card is included in the price, excluding shipping fees. * UK Delivery •4 * International Standard +• 8.00

Data science is quickly taking over all aspects of life, and a huge impact of this can be seen in the healthcare department. From medical imaging to genomics, we now leverage data to make better medical decisions. In this course, we will see how clinical trial data can be effectively managed using SAS.