Courses

Description

21 CFR Part 11 is the regulatory framework that this course is based on. It will provide a quick summary of CSV activities. The concepts of CSV, as well as various aspects of validation, will be discussed. This training will cover essential principles and an overview of computer systems compliance in general. The categorization of software and hardware according to GAMP 5, along with different validation techniques, are all part of this course. Developing URS, FRS, FAT, SAT, IQ, OQ, and PQ will also be reviewed

Courses Outcomes

By the end of the course, you will be able to:

• Understand the provisions of 21 CFR Part 11
• Categorize software and hardware according to GAMP
• Develop a URS, FRS, FAT, SAT, IQ, OQ, and PQ
• Understand different validation techniques
• Apply the concepts of CSV in real-world scenario

Who Should Attend

This course is beneficial for CSV professionals, software and hardware developers, quality assurance personnel, validation engineers/managers, and project managers. It will also be useful for those who want to enter the CSV field. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers) can also take this course.

Description

This course will provide you with a comprehensive introduction to CAAD, covering all the major topics and methods in the field. You will learn how to use CAAD tools to identify potential drug molecules, optimize their properties, and design experiments to test them. The course will also include a hands-on component (Software name), where you will use CAAD tools to solve real-world problems.

Courses Outcomes

By the end of the course, you will be able to:

• Understand the basics of CAAD
• Use CAAD tools to identify potential drug molecules
• Optimize the properties of drug molecules
• Design experiments to test drug molecules

Who Should Attend

This course is designed for students with a bachelor’s or master’s degree in pharmaceutical sciences, biochemistry, biotech, chemistry, or a closely related field who are interested in drug development research.

Description

Certification will be provided to the students after attending 75 hours of training and clearing the various tests conducted in our program. We cover all the important topics in Anatomy, Physiology, and Pathology.

ICD-10 CM, CPT-4, and HCPCS Coding and in-depth training are provided.
In ICD-10 CM coding guidelines and all specialties, including
Radiology
Pathology
Evaluation and Management
Surgery
Anesthesia coding

Medicine coding

Courses Outcomes

• Prepares you to attend either AAPC CPC Exam and/or AHIMA CCS-P exam
• Applying ICD-10-CM, CPT, and HCPCS codes based on medical documentation.
• Applying knowledge of medical terminologies, insurance, and regulation systems.
• Health care insurance terminology related to medical billing and the claims process.
• Basic anatomical, physiological and pathological terms used in the health care field
• Prepare health insurance claim forms, including CMS 1500 and UB-04.
• Operate health insurance software, including RVU Calculator, E/M Calculator & Health Plan/Provider Policy Search.

Who Should Attend

After taking this course, you can work as an intermediate medical coder in various clinics and hospitals. You will have in-depth knowledge of medical coding and will be able to work with more complex cases. In addition, having this certification will help you get jobs with better pay scales.

Description

Certification is provided to candidates after attending 40 hours of training and clearing the various tests conducted in the training program. The job training program covers all topics in Anatomy, Physiology, and Pathology. Introduction to ICD-10 CM, Basics of CPT-4 and HCPCS Coding.

Courses Outcomes

• To know the basics of medical coding & medical terminology.
• Understand the roles & responsibilities of a Medical Coder.
• Understand the concept of US health care
• Use a coding system to manage patient History & clinical data.
• Understand essential coding systems, which include ICD, CPT & HCPCS
• We provide you with actual hands-on experience and COVID medical coding guidelines in detail.
• Creating clean CMS 1500 forms.

Who Should Attend

After taking this course, you can work as an entry-level medical coder in various clinics and hospitals. In addition, having this certification will help you get jobs with better pay scales.

Description

This course is based on 21 CFR guidelines, designed to provide participants with an in-depth understanding of pharmacovigilance activities and how they are integrated into the drug development process. The topics covered include pharmacovigilance audits (RBI, PLA), risk management (REMS, CAPA, RMP, SMP), signal detection (AERS, VRMPT, RMP, SMP, SPE, PSR, etc), and product safety reviews (PSR, PSUR) based on GVP guidelines. In addition, you will also get a 30 hours hand on training on PvEdge software.

Courses Outcomes

Upon finishing this course, you will be able to:

• Demonstrate an understanding of pharmacovigilance activities and their role in the drug development process.
• Understand how to conduct a pharmacovigilance audit.
• Understand how to manage risk in pharmacovigilance.
• Demonstrate an understanding of signal detection in pharmacovigilance.
• Demonstrate an understanding of product safety reviews in pharmacovigilance.
• Understand how to use PvEdge software for pharmacovigilance activities.

Who Should Attend

This course is required for pharmacovigilance, regulatory affairs, and drug safety professionals. It’s also useful for those looking to enter the field of pharmacovigilance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers)

Description

This course will provide a comprehensive overview of how to manage and report safety information according to the latest international guidelines. The topics include audits, expectations for risk-based inspections (RBI), compliance with drug safety regulations like product approval/licensing agreements from Europe Union countries or other regions where they exist; also providing an introduction to Product Safety Reviews – its purpose function(incorporating CIOMS III requirements) as well new changes brought about by 2nd revision ICH E2C standards that are applicable today’s industry practices making them essential skills every company needs!

Courses Outcomes

Upon finishing this course, you will be able to:

• Recognize the fundamentals and intricacies of pharmacovigilance and drug safety.
• Recognize the reporting database for pharmacovigilance (e.g., Signal Detection, Risk Assessment, and Evaluation)
• Demonstrate an understanding of PV Guidelines (ICH E2C, WHO, etc.) and their practical applications in the workplace.
• Understand risk management concepts, tools, and methods for identifying and assessing risks.
• Examine signal management for causation assessment using a critical approach.
• Improve your writing skills when it comes to producing PV reports.

Who Should Attend

This course is required for pharmacovigilance, regulatory affairs, and drug safety professionals. It’s also useful for those looking to enter the field of pharmacovigilance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers.

Description

This course covers all aspects of drug regulation, from clinical trials to product approval and post-marketing surveillance in different countries. It provides a detailed understanding of DRA objectives, processes, and procedures. It includes ICH, eCTD, MDSAP, DCP, NDA, CMC, etc. The course also includes a 3-month internship at Sunshine Consultancy London Limited to provide you with the opportunity to gain hands-on experience in the regulatory affairs field.

Courses Outcomes

Upon finishing this course, you will be able to:

• Understand the objectives, processes, and procedures of Drug Regulatory Authorities (DRA)
• Understand, define and apply regulatory laws, guidelines, and procedures
• Prepare and submit regulatory documents such as IND, NDA, ANDA, etc.
• Conduct risk-benefit analysis and make sound regulatory decisions
• Prepare for and manage clinical trials
• Communicate effectively with clients, management, and health authorities
• Prepare and submit regulatory documents according to ICH, eCTD, MDSAP, and DCP guidelines
• Gain hands-on experience in the regulatory affairs field through an internship at Sunshine Consultancy London Limited.
• Take on the role of Regulatory Affairs Professional with ease.

Who Should Attend

This course is for professionals who want to take on a leadership role in regulatory affairs. It is also for those who want to specialize in a particular area of regulatory affairs, such as clinical trials, product approval, or post-marketing surveillance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc) with a background in the pharmaceutical and healthcare sector can also attend this course.

Description

This course will provide a comprehensive overview of the regulatory landscape relevant to the pharmaceutical and biotechnology industries. The focus of the course is on providing an understanding of the principles governing drug development and approval, as well as key aspects of regulatory compliance. It also includes ICH guidelines, CTD and eCTD modules, introduction to DMF, ASMF, and CMC, process validation, and product quality.

Courses Outcomes

Upon finishing this course, you will be able to:

• Understand the principles governing drug development and approval
• Understand the key aspects of regulatory compliance
• Write regulatory documents to communicate a company’s policies.
• Create a Regulatory Strategy that aligns with company goals and interests.
• Market pharmaceutical products in different countries with the proper licensing.
• Take on the role of entry-level Regulatory Affairs professional with ease.

Who Should Attend

This training is for pharmaceutical and biotech business professionals who are involved in regulatory affairs, such as QA/QC, R&D, production, and marketing. Students (B. Pharma/ M. Pharma/ B.Sc./M.) with a background in the pharmaceutical and healthcare sector..