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International conference on Unani and Traditional Medicine

International conference on Unani and Traditional Medicine

Location: , Sri Lanka
Category: Health and Medicine
Start Date: 03-23-2018
As a scientific research conference organizers, The Global Academic Research Institute proudly organized International conference on Unani and Traditional Medicine (ICUTM 2018) under the theme of “Unwinding Nature’s Recipes for Health” Unani & Traditional Medicinal have become a wide range of medicine around the world. The Research papers related are welcome from the Authors & Scientists, including those addressing this year’s conference theme. Please note that though you need send a proposed title and abstract at this stage, speakers are encouraged to submit a full paper before the conference. Research papers related to all areas of Unani and Traditional Medicine…
QS Connect MBA Event Munchen

QS Connect MBA Event Munchen

Location: , Germany
Category: Business and Economics
Start Date: 03-19-2018
Bereit für den nächsten Karriereschritt mit einem MBA aber noch nicht ganz sicher welches Studienprogramm das Richtige für Sie wäre? Bei dem QS Connect MBA Event in München helfen wir Ihnen gerne bei Ihrer Suche weiter. In persönlichen, 30min Einzelgesprächen mit über 20 führenden deutschen und internationalen Business Schools erhalten Sie alle Informationen zu den verschiedenen Studienprogrammen sowie den gängigsten Aufnahmeverfahren wie den GMAT. Die Vertreter der teilnehmenden Business Schools beraten Sie gerne auf jedem Schritt Ihrer MBA Bewerbung. Zusätzlich haben Sie die Möglichkeit bei informellen Networking Drinks ins Gespräch mit Alumni und gleichgesinnten Berufstätigen zu kommen. Teilnehmende Business Schools…
NDAs and INDs for Orally-Administered Drug Products

NDAs and INDs for Orally-Administered Drug Products

Location: , United States
Category: Education
Start Date: 02-28-2018
Overview: This webinar will be helpful to applicants conducting BA/BE studies during the IND period, also FDA guidance recommendations on how to meet the BA and BE requirements in 21 CFR 320 as they apply to oral dosage forms. Why should you Attend: Understanding when Bioavailability and Bioequivalence studies should be done can help attendees avoid having to re-do clinical trials, help to determine dosage regimen that achieves target drug exposure. Areas Covered in the Session: Review definitions necessary for understanding bioavailability and bioequivalence Review of FDA guidance recommendations on how to meet the BA and BE requirements in 21…
How Ensuring Data Integrity in Method Validations

How Ensuring Data Integrity in Method Validations

Location: , United States
Category: Education
Start Date: 02-28-2018
Overview: The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements to ensure Data Integrity. Why should you Attend: The guidance changes how FDA regulated methods will be developed, validated and used. Additionally, how to ensure Data Integrity will be discussed. The webinar will focus on detailing all key components of the guidance and analyze its validation parameters, tests, and acceptance criteria with respect to Data Integrity. Areas Covered in the Session: Scope and Content of the Guidance Performing Pre-Validation Studies Analytical Method Transfer Studies Data Integrity and Documentation Requirements Who Will Benefit:…
Fourth International conference on Social Science and Humanity

Fourth International conference on Social Science and Humanity

Location: , Sri Lanka
Category: Social Sciences and Humanities
Start Date: 02-23-2018
As a scientific research conference organizers, The Global Academic Research Institute proudly organized Third International conference on Social Science and Humanity (04th ICSSH 2018) under the theme of “Sustainable leadership for human development” . We welcome prospective participants and request them to send abstract and the full papers well ahead of the deadline. Both Oral and Poster presentations covering current research and new processes. The proposed Conference provides a suitable platform to all academics, leading researchers, professionals to share their knowledge and their achievement. All academic practitioners around the world are encouraged to submit their research abstracts, papers and posters…
Second International Conference on Non Communicable Diseases

Second International Conference on Non Communicable Diseases

Location: , Sri Lanka
Category: Health and Medicine
Start Date: 02-23-2018
As a scientific research conference organizers, The Global Academic Research Institute proudly organized Second International conference on Non Communicable Diseases (02nd ICNCD) under the theme of “Prevention & Control of NCD” We welcome proposals for papers and invitations for abstract submissions are now open for both Oral and Poster presentations covering current research and new processes. International Conference on Non Communicable Diseases (SICNCD 2018) is to provide a platform for eminent researchers, Scientists, academicians, physicians, Doctors, traditional medical practitioners, Consultants, Journalist and anyone in the domain of interest from around the world to discuss. Please note that though you need…
Underutilized and Underappreciated in Management Control

Underutilized and Underappreciated in Management Control

Location: , United States
Category: Education
Start Date: 02-21-2018
Overview: In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System (QMS). Why should you Attend: Management with executive responsibility is responsible for establishing a quality policy and objectives and for demonstrating a commitment to quality. And management at all levels should be aware of and engaged in quality efforts and customer focus. Areas Covered in the Session: Park Doctrine Lessons Learned Effective Management Review How to prioritize, resource, and implement improvements Tools for monitoring and communicating risk and improvement over time How to identify residual risk Who…
Learn Some of the Acceptance Activities in FDA QSR

Learn Some of the Acceptance Activities in FDA QSR

Location: , United States
Category: Education
Start Date: 02-21-2018
Overview: This section plays a major role in both purchasing and in production. It is a major contributor to determine whether your supplier and manufacturing process are working effectively. Why should you Attend: As you ensure that your Quality Management System meets FDA's regulations, you need robust acceptance activities. A gap could result in a Warning Letter, but even worse, it could also create a recall. This presentation provides the implementation information as well as the audit strategy to help verify your processes. Who Will Benefit: Operations Managers Production Supervisors Purchasing Managers Quality Engineers Manufacturing Engineers Speaker Profile: Dan is…
How to Comply with both in the Same Organization

How to Comply with both in the Same Organization

Location: , United States
Category: Education
Start Date: 02-16-2018
Overview: This ISO 13485:2016 webinar is a standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices. Why should you Attend: For people in the medical devices industry which either develops or planning to market medical devices to USA and Europe and plan to implant a QMS that complies with both regulatory authorities and ask themselves how to do it correct and efficiently. Areas Covered in the Session: Introduction Brief review of regulations and standard: status and…
Final Rules of Unique Device Identification

Final Rules of Unique Device Identification

Location: , United States
Category: Education
Start Date: 02-14-2018
Overview: This webinar will address the four key steps to compliance by device manufacturers. Also covered will be the Final Rule's provisions to address existing FG inventory, not properly labeled. Why should you Attend: It will also review the implementation schedule which is required of medical device companies selling products in the U.S. This is a major change for medical device manufacturers, with far-reaching effects in regulatory compliance, as envisioned by the FDA. Areas Covered in the Session: Learn the basic requirements of UDI Labeling and its Database UDI / GUDID Implementation Schedules Required steps for UDI / GUDID compliance…
QS World MBA Tour- Ciudad de Mexico

QS World MBA Tour- Ciudad de Mexico

Location: , Mexico
Category: Business and Economics
Start Date: 02-13-2018
Selecciona el MBA que mejor se adapte a tu perfil entrevistandote cara a cara con los directores de admision de algunas de las escuelas de negocio mas prestigiosas. Encontraras mas de 20 programas MBA de varias de las escuelas mas influyentes del mundo en Ciudad de Mexico el 13 de Febrero. Registrate gratis aqui: http://bit.ly/MexWMT Price QS World MBA Tour- México: MXN 0.00 Time: 5:00 pm to 9:00 pm
How to plan risk based approaches for clinical trials

How to plan risk based approaches for clinical trials

Location: , United States
Category: Education
Start Date: 02-12-2018
Overview: You will understand how to identify, evaluate and also how to implement specific risk based techniques for risk management used in clinical trials. Areas Covered in the Session: Have explained key risk based process/tools and techniques Review a risk based approach to protocol design Understand risk based approach to monitoring / data handling Review of risk based approaches to QC / QA (Auditing) Hear best practice of these new risk requirements Who Will Benefit: Clinical Development Managers and Personnel Clinical Research Associates Clinical Research Archiving and Document Management Personnel Quality Assurance Managers and Auditors Clinical Development Managers and Personnel…
Practices for Active Pharmaceutical Ingredients per ICH Q7

Practices for Active Pharmaceutical Ingredients per ICH Q7

Location: , United States
Category: Education
Start Date: 02-08-2018
Overview: The APIs covered in this guidance document include new chemical entities and APIs of biological origin and those created by biotech processes. Why should you Attend: This document was created to fulfil the need for specific guidance with regards to GMPs for APIs. Failure to meet these requirements is a significant source of observations during regulatory inspections by FDA or global regulators of manufacturers and/or of sponsors that use contract manufacturers and the contract manufacturers themselves. Areas Covered in the Session: Validation of Analytical Procedures, C of As, Stability Monitoring, Expiry dating Validation Policy, Documentation, Qualification, Process validation, Validation…
Why Capturing Justifications in Change Control

Why Capturing Justifications in Change Control

Location: , United States
Category: Education
Start Date: 02-07-2018
Overview: It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result. Areas Covered in the Session: Determine alternatives or options to the proposed solution Analyze costs, benefits, impacts, and risks of the proposed solution Validate the solution, assess product impact to the market Who Will Benefit: Quality Assurance/Quality Control Directors, Managers,and Specialists Regulatory Affairs/Regulatory Compliance Directors, Managers,and Specialists Engineering/Development Directors,…
How to Accurate Adverse Event Reporting

How to Accurate Adverse Event Reporting

Location: , United States
Category: Education
Start Date: 02-06-2018
Overview: Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects. Why should you Attend: With the increasing complexity of the Investigational Medicinal Products (IMP's), it behooves all who have any role in observing Study Participants to know the importance of accurately collecting all AE and SAE data. Areas Covered in the Session: How to know what an Adverse Event is and when to report it or them Knowing the AE…
How to Compliance with SaaS/Cloud Software Applications

How to Compliance with SaaS/Cloud Software Applications

Location: , United States
Category: Health and Medicine
Start Date: 02-05-2018
Overview: It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance. Areas Covered in the Session: Which data and systems are subject to Part 11 and Annex 11 What the regulations mean, not just what they say Avoid 483 and Warning Letters Requirements for local, SaaS, and cloud hosting SOPs required for the IT infrastructure Who Will Benefit: Laboratory Staff Managers GMP, GCP, GLP Professionals Auditors Software Vendors Speaker Profile: David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book…
How to Validate for Regulated Computer Systems

How to Validate for Regulated Computer Systems

Location: , United States
Category: Education
Start Date: 02-02-2018
Overview: You'll learn about the various computer system validation deliverables and how to document them through the entire process. You will learn about what must be done to ensure the system remains in a validated state. Why should you Attend: This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. Areas Covered in the Session: Installation Qualification Operational Qualification Performance Qualification Policies and Procedures Training Organizational Change Management Who Will Benefit: Clinical Data Managers and Scientists Compliance Managers and…
Information Security Management (Mini Master)

Information Security Management (Mini Master)

Location: , Netherlands
Category: Computer Science and Internet
Start Date: 02-01-2018
Information Security Management – a unique European Program on Information Security Management The 6-day Information Security Management Mini Master is realized in a collaborative effort of leading business schools, top practitioners and EuroCIO, and offers the required knowledge for Chief Information Security Officers to excel in their work environments. The Mini Master is part of the education portfolio of EuroCIO to foster European ICT professionalization. The program is compliant with the EU e-Competence Framework and provides you with insights into the most important aspects of Information Security Management, in particular related to leading and managing organizational Information Security activities. The…
Aware of the Similarities and Differences in the files

Aware of the Similarities and Differences in the files

Location: , United States
Category: Education
Start Date: 01-31-2018
Overview: It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Why should you Attend: companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier. Areas Covered in the Session: DHF "Typical" Contents and Deliverables The DMR and DHR / Lot / Batch Record TF / DD Required Contents Parallel Approaches to Documentation…
How software requirements are used in validation

How software requirements are used in validation

Location: , United States
Category: Computer Science and Internet
Start Date: 01-30-2018
Overview: This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing. Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements,analyses and tests that FDA feels are necessary to prevent user injuries. Areas Covered in the Session: Software Validation more than Testing Requirements Traceability Risk Analysis Unit,Integration and System Testing Algorithm Validation Challenges to the Software Configuration Management Who Will Benefit: Engineer Engineer Management Software Engineer Programmer Quality Assurance Regulatory Speaker…

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