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Environmental Monitoring Program at FDA Regulations - 2017

Environmental Monitoring Program at FDA Regulations - 2017

Location: , United States
Category: Education
Start Date: 08-10-2017
Overview: Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring. Why should you Attend: The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for Cleaning Validations of your manufacturing equipment? Areas Covered in the Session: Applicable Regulations - Where does the EM Program fit in the Regulation? - Role of Clean room Environmental Monitoring Program? Basics of Setting a Robust and Effective EM Program -…
FDA Inspection and Respond to 483 & How to Prepare them - 2017

FDA Inspection and Respond to 483 & How to Prepare them - 2017

Location: , United States
Category: Education
Start Date: 08-08-2017
Overview: In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection. Why should you Attend: FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter. Areas Covered in the Session: Personnel Preparation Facility needed to support inspection Behavior during inspection-what not to sign Internal/ Mock…
Validation Program to a Building from Top to Bottom - 2017

Validation Program to a Building from Top to Bottom - 2017

Location: , United States
Category: Education
Start Date: 08-04-2017
Overview: Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program. Why you should attend: How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program. Areas Covered In the Session: Discuss what FDA is really looking for in process validation Specify the deliverables associated with software validation Common pitfalls to avoid when executing validation protocols How to estimate costs and time associated with validation Who will benefit: Internal Auditors…
Effective Supplier Qualification Program - 2017

Effective Supplier Qualification Program - 2017

Location: , United States
Category: Education
Start Date: 08-03-2017
Overview: FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct. FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns. Areas Covered in the Session: Learn the pre-selection, selection and assessment process through the use of various tools Methods, techniques and strategies that work and are proven with supplier relations and qualification Learn how to apply risk-based approaches and why and how to "rank" suppliers Supplier Agreements, Quality Agreements and other documentation including Audits/Assessments Who Will Benefit: QA/QC/Compliance/Regulatory Affairs Engineering/R&D/Technical Services Purchasing/Procurement/Sourcing…
2018 5th International Conference on Education and Psychological Sciences (ICEPS 2018)

2018 5th International Conference on Education and Psychological Sciences (ICEPS 2018)

Location: , South Korea
Category: Education
Start Date: 01-27-2018 Last Day: 01-29-2018 Deadline for abstracts: 10-25-2017
Submission methods: 1. iceps@iedrc.net 2. https://easychair.org/conferences/?conf=iceps2018 Paper publication: For papers submitted to ICEPS 2018, we offer publication as following: Optition A: International Journal of Social Science and Humanity (IJSSH,ISSN: 2010-3646) Frequency: Bimonthly (2011-2014); Monthly (Since 2015) DOI: 10.18178/IJSSH Indexed by: Google Scholar, DOAJ, Engineering & Technology Digital Library, Crossref, Index Copernicus, and ProQuest. Optition B: International Journal of Information and Education Technology (IJIET,ISSN: 2010-3689) Frequency: Bimonthly (2011-2014); Monthly (Since 2015) DOI: 10.18178/IJIET Indexed by: EI (INSPEC, IET), Cabell's Directories, DOAJ, Electronic Journals Library, Engineering & Technology Digital Library, Google Scholar, Crossref and ProQuest
HIPAA 2017 Under Trump 2017

HIPAA 2017 Under Trump 2017

Location: , United States
Category: Education
Start Date: 08-24-2017 Last Day: 08-25-2017 Deadline for abstracts: 08-21-2017
Overview: The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises, and show how to find the right rule with the step-by-step procedures you need when you need them. Seminar Takeaways Thorough Understanding of HIPAA Rules • What they are • How they work together • Why and how they were made • How they are changing and what to expect next HIPAA Risk Analysis - Risk Management for Your Organization • A…
Lineament analysis and appropriate sampling and Quality Assurance Quality Control 2017

Lineament analysis and appropriate sampling and Quality Assurance Quality Control 2017

Location: , United States
Category: Education
Start Date: 08-24-2017 Last Day: 08-25-2017 Deadline for abstracts: 08-21-2017
Course "Lineament analysis and appropriate sampling and Quality Assurance/Quality Control (QA/QC) procedures to help you find your next mine" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Upon completing this course, participants should: • Understand the limitations of the current exploration process • Learn to use lineament and satellite interpretation as a way to define where to concentrate their exploration efforts • How to implement QA&QC procedures to guarantee the quality of the collected data Why you should attend: We will introduce you to an effective and…
Quality Management System ISO 13485- 2017

Quality Management System ISO 13485- 2017

Location: , United States
Category: Education
Start Date: 08-24-2017 Last Day: 08-25-2017 Deadline for abstracts: 08-22-2017
Course "Implementing ISO 13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice…
Documenting Software for FDA Submissions 2017

Documenting Software for FDA Submissions 2017

Location: , United States
Category: Education
Start Date: 08-10-2017 Last Day: 08-11-2017 Deadline for abstracts: 08-08-2017
Course "Documenting Software for FDA Submissions" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rather than contradict the Agile manifesto. The Agile approach helps companies…
Statistical Methods A Visual Approach 2017

Statistical Methods A Visual Approach 2017

Location: , United States
Category: Education
Start Date: 08-03-2017 Last Day: 08-04-2017 Deadline for abstracts: 08-01-2017
Course "Statistical Methods: A Visual Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information to accelerate the insight discovery process and…
Biosimilar from Development to Registration 2017

Biosimilar from Development to Registration 2017

Location: , United States
Category: Education
Start Date: 08-03-2017 Last Day: 08-04-2017 Deadline for abstracts: 08-01-2017
Course "Biosimilar from Development to Registration" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes: • Design and TPP • Pre-clinical testing and comparability • Clinical testing • Analytical studies • Stability of biosimilar products Why you should attend: The regulation of Biosimilars is very complex and the approach used by various regions differs. Professionals working in this complex area should…
FDA Effective Regulatory & Quality Submissions 2017

FDA Effective Regulatory & Quality Submissions 2017

Location: , United States
Category: Education
Start Date: 08-03-2017 Last Day: 08-04-2017 Deadline for abstracts: 08-01-2017
Course "FDA Legal Writing Skills that Result in Effective Regulatory & Quality Submissions" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments. Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceutical and medical device companies…
Data Integrity & Computer System Validation 2 Day Workshop 2017

Data Integrity & Computer System Validation 2 Day Workshop 2017

Location: , India
Category: Education
Start Date: 09-07-2017 Last Day: 09-08-2017 Deadline for abstracts: 09-07-2017
WCSAnnounces Seminar on Data Integrity & Computer System Validation 2 Day Workshop Sept 7-8 Hyderabad | Sept 11-12 Mumbai WCS announcesa Data Integrity & Computer System Validation Workshop in Sept 7-8 2017 in Hyderabad and Sept 11-12 in Mumbai. Data Integrity (DI) continues to attract increasing attention of regulatory agencies. As regulators boost their staff by hiring computer savvy personnel, business expediency requires pharmaceutical industry management to seek DI training for all their employees from qualified and experienced DI personnel. WCS’ DI trainingis designed with DI as its core theme. It is unlike other programs that use the Data Integrity…
Equipment Validation, Tracking, Calibration and Preventive Maintenance

Equipment Validation, Tracking, Calibration and Preventive Maintenance

Location: , United States
Category: Education
Start Date: 06-30-2017 Last Day: 06-30-2017 Deadline for abstracts: 06-29-2017
Description This session will review the regulatory requirements for validation, including detailed review of IQ, OQ, and PQ. A sample validation process will be followed through each phase. Documentation requirements for both protocol and results will be reviewed along with a list of pitfalls to avoid in documenting your validation. The importance of the Master Validation Plan will be discussed too. Preventive maintenance will be covered, including how to assure it does not adversely impact validated processes. A cost-effective equipment calibration program will be featured as well. FDA and EU regulations require that firms have a program for the calibration…
Mastering Excel PivotTables: Crunch Data More Efficiently Now!

Mastering Excel PivotTables: Crunch Data More Efficiently Now!

Location: , United States
Category: Education
Start Date: 06-30-2017 Last Day: 06-30-2017 Deadline for abstracts: 06-29-2017
Description In this session by expert speaker Dennis Taylor, you will learn the quickest and best ways to create PivotTables and Pivot Charts in Excel to analyze and represent data. This will be presented in Excel 2013 with references to Excel 2010 & 2016. Tools such as Sorting and Filtering in Excel allow users to easily manage large lists of data. However, if you require analyzing every data quickly, PivotTable is the best available option. Based on the huge data, you can quickly create a compact summary report without the use of complex formulas or lengthy techniques. The PivotTable feature…
Effective Food Safety and Quality Training Programs – How to Educate, Motivate and Empower Your Employees

Effective Food Safety and Quality Training Programs – How to Educate, Motivate and Empower Your Employees

Location: , United States
Category: Education
Start Date: 06-29-2017 Last Day: 06-29-2017 Deadline for abstracts: 06-28-2017
Description While it is vital that a food company must have knowledgeable managers on staff to keep up with food safety and quality, it is equally vital that the knowledge be shared with those front line employees. This can be a great weakness within companies as the task seems overwhelming and outside everyone's job description. Employees are your last line of defense in many cases for preventing food quality or safety deviations. Training them in a manner that is effective, useful and empowering is a priceless investment in the success of the company. If carried out effectively, food safety, quality…
Identifying and Managing Emerging Operational Risks

Identifying and Managing Emerging Operational Risks

Location: , United States
Category: Education
Start Date: 06-28-2017 Last Day: 06-28-2017 Deadline for abstracts: 06-27-2017
Description This webinar reviews the different definitions behind the concept of emerging risks, the different types of operational risks impacting firms today. Then, the webinar moves on to the principles of monitoring and mitigating some of these emerging risks, highlighting useful principles of risk identification and risk management. More importantly, the session will focus on process disciplines that can be adapted to ensure the organization is aware of, reacting timely to and monitoring the management of operational risks throughout the risk life cycle. As a final point, this session will also highlight responsibilities for the Board of Directors and Senior…
How to Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities

How to Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities

Location: , United States
Category: Education
Start Date: 06-28-2017 Last Day: 06-28-2017 Deadline for abstracts: 06-27-2017
Description This training will provide valuable knowledge on what companies need to do to establish an "effective" Compliance Office that leads to conceiving, developing and implementing successful GRC programs and provides top level coordinating leadership for governance, risk management and compliance issues across the enterprise. Objectives Of The Prsentation Discuss essential skill sets for both the CCO and CRO Assist companies in establishing the Compliance and/or Risk functions for effective governance Key factors will be assessed that will contribute to a successful transition of these two roles in organizations Review the roles and responsibilities for the CCO and CRO Evaluate…
Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions

Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions

Location: , United States
Category: Education
Start Date: 06-28-2017 Last Day: 06-28-2017 Deadline for abstracts: 06-27-2017
Description In many countries around the globe, certain medicines with a long history of use are allowed to be sold over the counter (OTC) at certain doses without a prescription. So the safety and efficacy are well known from a public health/patient safety perspective, a contaminated OTC medicine could potentially impact a larger user population than a prescription medicine. In some countries, OTC manufacturers are treated the same way as other drug manufacturers - their products are after all medicines and are inspected to the same standards and at the same frequencies. In the U.S., OTC manufacturers must meet 21…
Understanding Federal Government Payments

Understanding Federal Government Payments

Location: , United States
Category: Education
Start Date: 06-28-2017 Last Day: 06-28-2017 Deadline for abstracts: 06-27-2017
Description While the Federal Government uses the ACH Network to process many payments, they have unique rules for some transactions and processes, requirements that vary quite drastically from other types of ACH transactions. This course explores where the Federal Government rules differ from ACH Rules and helps attendees understand their obligations when processing Federal Government payments. We will also explore common situations like how to enrol an account holder, managing returns and notifications of change, and more. Objectives Of The Presentation Identify how to navigate the Federal Government Payment Rules Locate appropriate rules that apply to given situations Record effective…

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