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1
GxP Quality Management System (QMS): Moving from Compliance to Quality
01 nov 2019 • Fremont, États-Unis
Organisateur:
Compliance4All
Résumé:
There are those of us who think that the psychology of man, each and together, has more impact on markets, business, services, construction, and the entire fabric of an economy than all the more measurable statistical indices.- Malcom S. Forbes. Too narrow a focus on regulatory compliance prevents organizations from embracing-and profiting from-quality and operational excellence. A major step towards ensuring GxP compliance and quality is the implementation of a quality management system (QMS). There are measureable benefits to having a sustained, operational QMS. However, implementing a QMS is, at its core, change and the derived benefits of any change are often forgotten when confronted with the uncertainty that accompanies it.
Contact:
Event Manager;     Tél.: [18004479407];     Email.: compliance4all14@gmail.com
Sujets:
Managers & Supervisors, Process Owners, Departmental Heads
Identifiant de l'évènement:
1273072
2
Comparability Protocols for Approved Drugs
04 nov 2019 • Fremont, États-Unis
Organisateur:
Compliance4All
Résumé:
This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.
Contact:
Event Manager;     Tél.: [18004479407];     Email.: compliance4all14@gmail.com
Sujets:
Process and Design Engineering, Process Automation, Manufacturing Operations
Identifiant de l'évènement:
1273137
3
Effective Records Management & Document Control for Medical Devices
05 nov 2019 • Fremont, États-Unis
Résumé:
Overview

The document management system for medical device industry should help companies have control over critical activities such as:

Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes

Conducting Risk Assessment, Root Cause Analysis and Impact Assessment where appropriate

Creating Action Plans, and verifying their effectiveness

Improving efficiencies over the QMS tasks

Reducing the risks of manual error

Ensuring compliance to 21 CFR Part 11 and immutable audit trail

Avoid observations, 483 letters and fines

Taking the resource burden out of creating dashboards/ periodic reports

Why should you Attend

Do you have unapproved or outdated documents in circulation?

Are your SOP revisions being done in an uncontrolled or inefficient manner?

Does your production team use confusing formats that create uncertainty in record-keeping?

In the Medical Device industry, companies must "establish and maintain" documents, procedures, and records. This can involve huge numbers of documents. Without a system for control, this can quickly become burdensome and out of control. This can have disastrous consequences in an FDA inspection.

This webinar will examine the ideas associated with the development and control of quality documentation.

Areas Covered in the Session

QSR and ISO 13485 requirements for document control

Description of typical document control system in use

How to create uniform documentation that is easy to follow

Establish systems that will speed up review of new or revised documents

Streamlined document control process

Eliminate common formatting problems that create confusion

Create more control over controlled documents in circulation

Ensure obsolete documents are removed from use

Who Will Benefit

This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

Document Control Personnel

QA Managers and Personnel

Quality Control Personnel

Facility Maintenance and Calibration Personnel

Manufacturing and Operations Personnel

Any employee Involved in Regulatory Audits

Executive Management

Document Control Clerks

Consultants

Quality System Auditors

Speaker Profile

Denise Wrestler ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs.

Contact:
Event Manager;     Tél.: [510-962-8903];     Email.: traininngdotcom@gmail.com
Sujets:
Executive Management, Document Control Clerks, Consultants, Quality System Auditors
Identifiant de l'évènement:
1279271
4
Surviving OSHA Audit in Six Easy Steps
07 nov 2019 • Fremont, États-Unis
Organisateur:
Compliance4All
Résumé:
Learn how to quickly spot violations in the workplace and how to correct them to OSHA standards by attending this webinar. The attendee will also be made aware of the most frequent violations, compliance strategies and the defense against citation. OSHA has a playbook that is used by each compliance and safety officer; the attendees will learn how to obtain a copy for free and tips for learning the content. Moreover, this webinar will give practical steps to an effective Injury and Illness Prevention Program (I2P2).
Contact:
Event Manager;     Tél.: [18004479407];     Email.: compliance4all14@gmail.com
Sujets:
HR Professionals, Chief Engineers, Department Heads, General Managers
Identifiant de l'évènement:
1273070
5
The Top Ten Excel Functions Everyone Should Know
11 nov 2019 • Fremont, États-Unis
Résumé:
Overview

Excel functions can greatly enhance your ability to perform tasks in day to day activities in Excel. While there are hundreds of functions in available, there are 10 functions that all Excel users should know. Whether you are an office worker, or a small business owner using Excel to keep track of your finances or just the casual user, these Excel functions can be very important time savers and enhance your ability to create better performing spreadsheets!

Why should you Attend

This webinar will get you started with functions. You will learn not only HOW to use these functions, but WHY they do what they do. Knowing the "why" helps you to do more with Excel. Attendees should have basic knowledge of creating Excel calculations using the basic mathematical operators and know the difference between relative and absolute cell references. This course is for beginner to intermediate Excel users.

Areas Covered in the Session

Learn many statistical functions including SUM, AVERAGE, MAX, MIN and COUNT

Use IF and its counterparts COUNTIF, SUMIF, and AVERAGEIF

Understand VLOOKUP

Calculate dates using TODAY, NOW and NETWORKDAYS

Learn many functions to manipulate text once imported including LEFT, RIGHT, LEN, TRIM and CONCANTENATE

Use IFERROR when errors can't be avoided

Who Will Benefit

Business Owners

CEO's / CFO's / CTO's

Managers

Accountants

CPA's

Financial Consultants

IT Professionals

Auditors

Human Resource Personnel

Bookkeepers

Marketers

Anybody with large amounts of Data

Anybody who uses Microsoft Excel on a regular basis, and wants to be more efficient and productive

Speaker Profile

Cathy Horwitz is an independent consultant specializing in Microsoft Office instruction. She has over 30 years of experience as a Microsoft Office instructor. Cathy is proficient in all levels of Excel, Word, PowerPoint, Outlook and Access. Cathy holds a degree in Psychology and a Master in Business Administration degree with an emphasis in Human Resources.

Contact:
Event Manager;     Tél.: [510-962-8903];     Email.: traininngdotcom@gmail.com
Sujets:
Accountants, Financial Consultants, IT Professionals, Auditors
Identifiant de l'évènement:
1279292
6
AML High-Risk Transactions - Identify, Manage, Resolve
12 nov 2019 • Fremont, États-Unis
Résumé:
Overview

This webinar will discuss the techniques for controlling and managing High Risk Transaction. The Instructor will discuss the parameters for identifying and qualifying transactions as high risk and process and communication to be followed. He will also discuss how to resolve the end result.

Why should you Attend

AML operations, systems, and processes are designed to provide sound compliance and appropriate reporting of Suspicious Activity to Regulators on SARS.

Properly identifying the high-risk activity will focus compliance priorities properly. Properly managing high-risk transactions when they are identified is equally important. Together, they help avoid reporting failures which can lead to sanctions against the bank.

This webinar will cover both the identification and the management aspects of high-risk transactions.

Areas Covered in the Session

Learn what are elements of transactions which can cause a transaction to be considered "high-risk" and how to make judgments in each category:

Countries involved

Customers involved

Counter parties involved

Product type or transaction type

Learn how to manage high-risk transactions and what the options are for completing that

Characteristics that can cause a transaction to be considered high-risk

In bank's organization, type of work that will need to be performed

Identify key places in the workflow where communication to other areas is necessary and why there have been failures at this in the past

Techniques for controlling and managing high-risk transactions

End results that may occur:

Weighing analytical engines

Special reviews

SAR

End the customer relationship

Section 314(b) sharing with other institutions

Who Will Benefit

Fraud Professionals

Compliance Professionals

AML/BSA Professionals

Banking VP

Bank Director

Bank Supervisor

Bank Managers

Credit Unions Manager

Credit Unions VP

Credit Unions Director

Credit Unions Supervisor

Financial Services Managers

Financial Services VP

Financial Services Director

Financial Services Supervisor

Banking Professional

Credit Unions Professionals

Financial Services Professionals

Speaker Profile

Jim George is an independent consultant to banks focusing on issues of fraud. He brings over 25 years as a consultant to major banks in Associate Partner and Principal roles at PriceWaterhouse-Coopers Consulting, IBM Consulting in Bank Risk and Compliance and Andersen Consulting (now Accenture).

Contact:
Event Manager;     Tél.: [510-962-8903];     Email.: traininngdotcom@gmail.com
Sujets:
Bank Supervisor, Bank Managers, Credit Unions Manager, Financial Services Director
Identifiant de l'évènement:
1279324
7
Poultry's Role in Food Security and Sustainability
13 nov 2019 • Fremont, États-Unis
Organisateur:
Compliance4All
Résumé:
Poultry is big business. Rarely a month goes by without some sort of poultry food safety recall. Poultry farms are constantly in the news for questionable practices regarding how poultry are raised, impact on regional water sources, what drugs are fed to them, the environmental impact of manure, egg varieties and pricing, bacterial contamination of eggs, disposal of dead poultry and a variety of other factors impacting the industry's ability to meet poultry product demand and environmental sustainability requirements. This webinar will look at poultry's role in food security and sustainability. While companies can supply poultry, eggs and poultry products in many forms, large poultry flocks are often threatened by disease outbreaks (avian influenza), regional legislation, and consumer demands for "caged", "natural", "free range" and other continuously changing factors.Poultry are a basic dietary need for most societies and cultures and must be produced in a manner that helps to sustain the environment in order to continually provide a secure food source for humans.
Contact:
Event Manager;     Tél.: [18004479407];     Email.: compliance4all14@gmail.com
Sujets:
Poultry growers, packers, handlers, transporters
Identifiant de l'évènement:
1273157
8
Early Completion Schedules - Benefits, Risks & Defenses
14 nov 2019 • Fremont, États-Unis
Résumé:
Overview

A contractor's right to complete work early was acknowledged by U.S. Courts in the 1940's. As a result, delayed early completion claims became much more common in the 1960's. It was then, and remains now, a controversial issue in the construction industry with many project owners refusing to accept early completion baseline schedules. Others crafted contractual mechanisms prevent or defeat such claims.

The purpose of this webinar is to set forth the background concerning a contractor's right to complete work early and examine the contractor's right to seek an equitable adjustment should their early completion be delayed by action of the owner. The webinar identifies the potential benefits and risks for both owners and contractors. Additionally, this webinar provides a brief overview of several different ways owners can defend against claims oriented early completion schedules.

Why should you Attend

Understand the background of the contractor's right to complete work earlier than required under the contract

Gain information on what is an early completion schedule and why some contractors use them on projects

Learn how to review early completion schedules and determine if they are legitimate schedules or claims oriented schedules

Learn about early completion delay claims and what contractors must prove to recover damages

Gain information about the contractor's perceived advantages for creating and submitting an early completion schedule

Discover 12 ways an owner to avoid claims oriented early completion schedules

Areas Covered in the Session

Learn about the two forms of early completion schedules common on construction sites

Understand how and why early completion schedules are constructed

Explore the issue of whether a contractor is obligated to inform an owner of their planned early completion

Review some recent U.S. court decisions concerning early completion schedules

Be exposed to the pros and cons of having an early completion schedule on your project

Who Will Benefit

Owners and Owner representatives Managing Capital improvement Projects

Contractor Executives, Project Managers, Project Sponsors and Project Control Personnel

Construction Managers and Design Professionals Performing services during Construction

Attorneys representing Owners, Contractors, Construction Managers & Design Professionals performing services during Construction

Speaker Profile

James G. Zack, CFCC, CCM, FAACE, FGPC, FRICS, PMP Senior Advisor, Ankura Construction Forum™ - the construction industry's global resource for thought leadership and best practices on avoidance and resolution of construction project disputes globally. Formerly, Jim was the founder and Executive Director of the Navigant Construction Forum™.

Contact:
Event Manager;     Tél.: [510-962-8903];     Email.: traininngdotcom@gmail.com
Sujets:
Contractor Executives, Project Managers, Project Sponsors, Design Professionals
Identifiant de l'évènement:
1279334
9
A straightforward method for meeting FDA Requirements for Design Inputs and Outputs
18 nov 2019 • Fremont, États-Unis
Résumé:
Overview

A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented. A DIOM ensures design information is clearly presented, well-documented, and most importantly, located within one simple document. This webinar provides a simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both.

The speaker has worked on numerous design development projects in Class II and Class III medical devices as well as establishing Quality Management Systems which include easy-to-understand methods to meet design development and design control requirements. This webinar will walk you through step-by-step how to complete a DIOM for your product and simplify this often overly complex process.

Why should you Attend

Better understanding of FDA regulations with regards to design input and output

An organized approach in meeting design input and output requirements

A simplified way to ensure design inputs and outputs are continually maintained and tracked

Areas Covered in the Session

Introduction to the DIOM template

How to identify your design inputs

How to categorize your design inputs and their sources

Ways in which design inputs can be verified

Common documents and activities used as design output evidence

Additional requirements of design inputs and outputs

Who Will Benefit

Quality Assurance

Regulatory Affairs

Design Engineers

Manufacturing Engineers

Startup Companies

Speaker Profile

Denise Wrestler ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs.

Contact:
Event Manager;     Tél.: [510-962-8903];     Email.: traininngdotcom@gmail.com
Sujets:
Quality Assurance, Regulatory Affairs, Design Engineers, Manufacturing Engineers
Identifiant de l'évènement:
1279377
10
Food Waste Reduction: The Road to Cost Reductions and Sustainability
20 nov 2019 • Fremont, États-Unis
Organisateur:
Compliance4All
Résumé:
Food waste is a well-recognized issue throughout the food supply chain. Loss estimates run anywhere from 30% to 50%. Water, fertilizer, manpower, facility overhead costs, delivery/planting/production/storage and delivery, carbon emissions, environmental pollution and other food production expenses are lost along with the food that cannot be consumed. Food waste, as defined by the U.N.'s Food and Agriculture Organization, refers to the "discarding or alternative (non-food) use of food that is safe and nutritious for human consumption along the entire food supply chain, from primary production to the end household consumer level." In 2015, the Environmental Protection Agency announced the first-ever domestic goal to reduce food loss and waste by 50 percent by 2030.
Contact:
Event Manager;     Tél.: [18004479407];     Email.: compliance4all14@gmail.com
Sujets:
Foreign Food Producers, Importers and Exporters, Food Safety and Quality Specialists
Identifiant de l'évènement:
1273189
11
Export Certificate for Medical Devices - Edge Out your Competition!
20 nov 2019 • Fremont, États-Unis
Organisateur:
Compliance4All
Résumé:
In today's global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries. To this end, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations. In submitting export certificates, any mistake, no matter how minor, can delay product approvals, launches, or cause widespread public relations disasters. Therefore, understanding and correct execution of the export certificate processes has become a competitive advantage for global manufacturers of medical devices.
Contact:
Event Manager;     Tél.: [18004479407];     Email.: compliance4all14@gmail.com
Sujets:
Regulatory Affairs, Quality Assurance, Clinical Research
Identifiant de l'évènement:
1273100
12
Using VLOOKUP, MATCH, and INDEX
20 nov 2019 • Fremont, États-Unis
Résumé:
Overview

This webinar is for any user of Excel who works with large amounts of data and has data in multiple worksheets. Learning about the lookup functions will allow you to match data between databases.

Learn about VLOOKUP function in Excel which enables you to quickly and easily look for a value down a column of data and return a value from the same row in a different column. Perfect for when working with large tabular data.

INDEX and MATCH work in a similar way but provide more flexibility.

In just one fast-paced and informative training session, you’ll learn how to use lookup functions to let you work with your data more efficiently and gain powerful new tools to help you manipulate data and make better business decisions.

Why should you Attend

If you handle large amounts of data in Excel, this webinar on how to use VLOOKUP, MATCH and INDEX will help you tremendously.

The training will be delivered using Excel 2016 for Windows although for users of earlier versions, most of the functionality is available in Excel 2010 and Excel 2013.

Areas Covered in the Session

Learning the arguments in the VLOOKUP function

Understanding the importance of absolute references within many lookup functions

VLOOKUP function in Excel for performing approximate matches

Simplifying multiple-field look-ups with concatenation (combining fields into a single cell)

Discovering how to use wildcards and multiple criteria within lookup formulas

Using VLOOKUP to look up data from another workbook

Learning how VLOOKUP stops looking after it finds an initial match within a list

Exploring why VLOOKUP sometimes returns #N/A instead of a desired result

Learning about the IFNA function available in Excel 2013 and later

Use the IFERROR function to display something other than an #N/A error value when VLOOKUP can't find a match

Seeing how the HLOOKUP function enables you to perform horizontal matches

Learning why the INDEX and MATCH combination often is superior to VLOOKUP or HLOOKUP

Using the MATCH function to find the position of an item on a list

Perform dual lookups, allowing you to look across columns and down rows to cross-reference data you need

Future-proof VLOOKUP by using Excel's Table feature versus referencing static ranges

View two worksheets from within the same workbook at the same time

Who Will Benefit

Business Owners

CEO's / CFO's / CTO's

Managers

Accountants

CPA's

Financial Consultants

IT Professionals

Auditors

Human Resource Personnel

Bookkeepers

Marketers

Anybody with large amounts of Data

Anybody who uses Microsoft Excel on a regular basis, and wants to be more efficient and productive

Speaker Profile

Cathy Horwitz is an independent consultant specializing in Microsoft Office instruction. She has over 30 years of experience as a Microsoft Office instructor. Cathy is proficient in all levels of Excel, Word, PowerPoint, Outlook and Access. Cathy holds a degree in Psychology and a Master in Business Administration degree with an emphasis in Human Resources.

Contact:
Event Manager;     Tél.: [510-962-8903];     Email.: traininngdotcom@gmail.com
Sujets:
IT Professionals, Auditors, Human Resource Personnel, Bookkeepers
Identifiant de l'évènement:
1279332
13
Ready-to-Eat (RTE) Foods and the Role of the Environment and Water
26 nov 2019 • Fremont, États-Unis
Organisateur:
Compliance4All
Résumé:
One of the three most critical food safety issues facing the food industry today is environmental contamination of ready-to-eat foods (RTEs). Ready-to-eat foods have no kill step applied between the sale of the product and consumption by consumers. Demand for such product is drastically increasing as consumers look for increasing levels of convenience. Over the past several years, FDA recall investigations have repeatedly shown that most farms are impacted by a myriad of environmental bacterial contaminants, man applied chemicals and impossible to remove physical hazards. The FDA has failed to report these findings due to the inability of science and technology to quickly test for and verify such contaminants prior to shipment to market.
Contact:
Event Manager;     Tél.: [18004479407];     Email.: compliance4all14@gmail.com
Sujets:
Foreign food producers, importers and exporters, Food safety and quality specialists
Identifiant de l'évènement:
1273176


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Dernière mise à jour: 08 Octobre 2019