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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,…
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…
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…
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.…
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…
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…
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 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…
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…
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…
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…
KAB02:0 70@C156=KE 3@0

KAB02:0 70@C156=KE 3@0

Location: , Russia
Category: Education
Start Date: 02-27-2018 Last Day: 02-27-2018 Deadline for abstracts: 02-26-2018
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The European Journal of Arts

The European Journal of Arts

Location: , Austria
Category: Education
Start Date: 02-28-2018 Last Day: 02-28-2018 Deadline for abstracts: 02-28-2018
The journal is registered and published in Austria. Articles on art studies and cultural studies are published in the journal. Journal is published in English, German and Russian. Example of output data of an article – Mark, Smith. History of arts in Europe // The European Journal of Arts, Premier Publishing s.r.o. Vienna. 3, 2017, - Pp. 112-117. Periodicity: 3 issues per year. Articles are accepted till the 30th day of the months: Till the 28th of February Till the 30th of June Till the 30th of October The journal is intended for students, graduate students, postgraduate students, postdoctoral students,…
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:…
KAB02:0 70@C156=KE 5B5@1C@35

KAB02:0 70@C156=KE 5B5@1C@35

Location: , Russia
Category: Education
Start Date: 03-01-2018 Last Day: 03-01-2018 Deadline for abstracts: 02-28-2018
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Eleventh International Conference on e-Learning & Innovative Pedagogies - St John's University

Eleventh International Conference on e-Learning & Innovative Pedagogies - St John's University

Location: , United States
Category: Education
Start Date: 03-02-2018 Last Day: 03-03-2018 Deadline for abstracts: 02-02-2018
e-Learning and Innovative Pedagogies Research Network: a conference and journal founded in 2006, exploring the affordances for innovative and transformative forms of learning offered by the new information and communications technologies.
6th Asia Pacific Conference on Advanced Research (APCAR-  2018)

6th Asia Pacific Conference on Advanced Research (APCAR- 2018)

Location: , Australia
Category: Education
Start Date: 03-02-2018 Last Day: 03-04-2018
The 6th Asia Pacific Conference on Advanced Research (APCAR- 2018) will be held on 2nd, 3rd and 4th of March 2018 in Melbourne, Australia. 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 constructive critique on your ideas: benefit from the audience…
Teacher Skills Forum

Teacher Skills Forum

Location: , Jordan
Category: Education
Start Date: 03-02-2018 Last Day: 03-04-2018
The Teacher Skills Forum is an initiative of Queen Rania Teachers Academy in partnership with the International Baccalaureate Organization, it aims to provide teachers with opportunities and access to: learn new teaching strategies and techniques; to discuss possible action points and goals for enhancing classroom and school communities; to share and apply best teaching practices; to network and create lasting relationships based on a shared vision; to provide teachers with the skills to develop modern, innovative lessons that incorporate technologies into classroom instruction; and to support teachers to prepare students to compete in a knowledge driven economy. The Teacher Skills…

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