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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:…
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Location: , Russia
Category: Education
Start Date: 02-27-2018 Last Day: 02-27-2018 Deadline for abstracts: 02-26-2018
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Evolution of the Quality Management System - How to go from Surviving to Thriving

Evolution of the Quality Management System - How to go from Surviving to Thriving

Location: , United States
Category: Education
Start Date: 02-22-2018 Last Day: 02-23-2018 Deadline for abstracts: 02-21-2018
Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and developing your improvement strategy. We'll discuss tools and techniques for improvement and how to measure your progress. Why you should attend: Many companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. An ineffective QMS can result in serious consequences for…
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…
Future of Youth Skills and Employment

Future of Youth Skills and Employment

Location: , Australia
Category: Education
Start Date: 02-20-2018 Last Day: 02-21-2018 Deadline for abstracts: 02-19-2018
The recent ‘New Work Smarts’ report by the Foundation for Young Australians has found a third of young people are unemployed or underemployed. Of those seeking to improve their career prospects, 60% are studying for jobs that will be obsolete in 30 years time. Rapidly evolving technologies are shifting the way we work and the types of jobs available. In response, we need to equip youth with the right skills, information and opportunities to succeed in the future workplace. The Future of Youth Skills and Employment conference brings together the key government, community and education stakeholders responsible for supporting the…
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…
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…
2018 7th International Conference on Education and Management Innovation (ICEMI 2018)

2018 7th International Conference on Education and Management Innovation (ICEMI 2018)

Location: , Italy
Category: Education
Start Date: 02-11-2018 Last Day: 02-13-2018 Deadline for abstracts: 12-15-2017
Publication All papers for the ICEMI 2018 will be selected and published according to the paper theme in the following journals: International Journal of Innovation, Management and Technology (IJIMT, ISSN: 2010-0248, DOI: 10.18178/IJIMT), and will be included in Google Scholar, Ulrich's Periodicals Directory, Engineering & Technology Digital Library, Crossref and ProQuest, Electronic Journals Library. International Journal of Information and Education Technology (IJIET, ISSN: 2010-3689, DOI: 10.18178/IJIET), and will be included in EI (INSPEC, IET), Cabell's Directories, DOAJ, Electronic Journals Library, Engineering & Technology Digital Library, Google Scholar, Crossref and ProQuest. There are two methods for submitting your paper: 1. By…
Green Business - UK Launch - Special Event - Find out More - Business Day

Green Business - UK Launch - Special Event - Find out More - Business Day

Location: , United Kingdom
Category: Education
Start Date: 02-10-2018 Last Day: 02-10-2018 Deadline for abstracts: 02-10-2018
Get your 2018 off to a rip roaring start. This exciting opening event in London is the place to be for all of you wanting to get off to a flying start with RINGANA in the UK. Spend a Day with us - Winner of the 2017 European Business Award - Chairman's Award - and learn how & why we are growing annually at over 40-50% and how you can join our successful Green Business and build a potentially properous future. A unique opportunity with an award winning company - with integrity. This is what you can look forward to.…
4th International Conference on Theory and Practice (ICTP- 2018)

4th International Conference on Theory and Practice (ICTP- 2018)

Location: , Australia
Category: Education
Start Date: 02-09-2018 Last Day: 02-10-2018 Deadline for abstracts: 02-09-2018
The 4th International Conference on Theory and Practice (ICTP- 2018) will be held on 9th and 10th of February 2018 in Adelaide, Australia. The main theme of this conference is 'Lighting the Future'. The conference will cover every topic from the areas of Business, Education, Social Sciences and ICT. Internationally-recognized scholars will participate in the event to present their latest research and best practices. We, the conference organisers invite you to participate in this event where you can: Strengthen your professional ties: this may lead to publications and job opportunities – an invaluable opportunity for post-PhD professionals. Receive feedback and…
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,…
The International Conference on Future of Women ’18

The International Conference on Future of Women ’18

Location: , Malaysia
Category: Education
Start Date: 02-06-2018 Last Day: 02-07-2018 Deadline for abstracts: 11-14-2017
The International Institute of Knowledge Management (TIIKM) welcomes you to the International Conference on Future of Women ’18 to be held on the 06th – 07th February, 2018 in Kuala Lumpur, Malaysia under the theme “A Prospect for Greater Vision.” The main objective of Future of Women ‘18 is to set up the platform that serves as the center stage to voice for women foreseeing a diversification in the ideas leading towards a greater vision for the future.
Feira internacional de MBA: QS World MBA Tour Sao Paulo

Feira internacional de MBA: QS World MBA Tour Sao Paulo

Location: , Brazil
Category: Education
Start Date: 02-06-2018 Last Day: 02-06-2018 Deadline for abstracts: 02-06-2018
Encontre o MBA perfeito para voce na QS World MBA Tour em Sao Paulo! Registre-se gratis: http://bit.ly/2hARNFA Por que participar: . Fale diretamente com diretores de admissao dos melhores MBAs internacionais . Assista seminarios gratuitos . Receba dicas sobre os testes preparatorios, como o GMAT . Concorra a bolsas de estudo exclusivas e muito mais! Price: QS World MBA Tour - Sao Paulo: BRL 0.00 Time: 4:30 pm to 9:00 pm
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…
QS Connect MBA - São Paulo

QS Connect MBA - São Paulo

Location: , Brazil
Category: Education
Start Date: 02-05-2018 Last Day: 02-05-2018 Deadline for abstracts: 02-04-2018
Se você está pronto(a) para dar o próximo passo na sua carreira, mas ainda não tem certeza sobre qual programa de MBA escolher, não perca a oportunidade de participar do QS Connect MBA e se encontrar pessoalmente com algumas das escolas de negócios mais renomadas internacionamente. Reserve sua vaga gratuitamente: http://bit.ly/2z3N0Ux 4 passos para agendar suas entrevistas: 1. Faça sua inscrição 2. Anexe seu currículo em Inglês ao seu perfil ou envie para resume@qs.com 3. Nossos consultores e as escolas irão analisar seu perfil e enviarão seus convites para as entrevistas 4. Confirme sua presença Price: QS Connect MBA -…
Drug dissolution testing and establishing plasma drug levels in humans

Drug dissolution testing and establishing plasma drug levels in humans

Location: , United States
Category: Education
Start Date: 02-05-2018 Last Day: 02-06-2018 Deadline for abstracts: 02-04-2018
Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe…
HIPAA 2018 - Understanding Compliance Program Requirements 2018

HIPAA 2018 - Understanding Compliance Program Requirements 2018

Location: , United States
Category: Education
Start Date: 02-05-2018 Last Day: 02-06-2018 Deadline for abstracts: 02-04-2018
Being in compliance with HIPAA in 2018 involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a breach investigation you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how…

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