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  • 1 Request Info

    FDA and EMA Global labeling challenges faced in day-to-day operations

    Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), Summaries of Product Characteristics (SmPCs) and Core Data Sheets (CDSs). The large number of product strengths, dosage forms and product presentations results in a large number of labeling records that must be maintained and kept synchronized. The FDA and EMA are implementing a set of rules for the electronic submission of labeling content. The FDA labelling regulation requires companies to submit XML labeling content in Structured Product Labeling (SPL) format. The EMA labelling regulation requires companies to submit product information documents in QRD-compliant format.
  • 2 Request Info

    Measure the Cause Not the Effect of Process Variation

    Process Reliability Modeling (PRM) examines organizations transactional, reliability engineering training or manufacturing processes to determine the likelihood of passing work through each process with errors resulting in costly rework and customer disaffection. Reliability training courses of every process is accomplished by interviewing all employees by process throughout the organization. Qualitative information gained from interviews is analyzed using Cause and Effect Diagrams.
  • 3 Request Info

    Automating Excel: Introduction to Dashboards

    Overview In this enlightening webinar, Excel expert David H. Ringstrom, CPA, introduces you to Microsoft Excel worksheet dashboards. David typically teaches from Excel 2016, but he points out any differences in earlier versions of Excel. He’s also happy to demonstrate techniques in a specific version of Excel spreadsheet upon request. David’s detailed handouts serve as reference tools you can fall back on after participating in one of his webinars. He also provides an Excel dynamic dashboard workbook that includes a majority of the examples he uses during this webinar. Why Should You Attend Learn a variety of techniques for presenting Excel data in dashboard form and how to quickly assimilate large amounts of data within charts and summary tables. For more detail please click on this below link: http://bit.ly/2t8w0ro Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510
  • 4 Request Info

    Webinar on Terminal Radar Approach Control (TRACON) Operations

    Overview: Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely. In reality, air traffic control is the process by which many thousands of aircraft are provided separation services as they climb, descend, and cross paths and altitudes as they travel from any one of thousands of departure airports to any one of thousands of destination airports daily. Air traffic controllers in various ATC facilities are responsible for specific airspace volumes and may be providing those ATC separation services to up to 20 - 25 aircraft at any moment in time. Core ATC concepts, procedures, and techniques have evolved to enable human air traffic controllers to safely manage that level of air traffic density and volume.
  • 5 Request Info

    Webinar on Physical Security - How to Ensure That Your Facility and Employees are Safe

    Overview: Knowing that your organization and facility are secure are key to continual operations. If potential and real threats minimized, day-to-day operations can continue to occur. No matter what type of work takes place, lost hours equates to a loss in revenue and profits. An organization should not suffer through some simple security measures. Are the entrances and exits secure. Most would say yes, but have you have taken the time to think about and perform a security assessment? Most assessments lead to more questions as potential threats are not often thought of or corrected enough. Are employees checked prior to employment, during employment, and are measures in place to ensure that they could not come back to harm the organization or any of those within the organization? Are visitors checked in, escorted at all times, and escorted out of the facility correctly? These simple tasks and many others will be reviewed and gone over in depth.
  • 6 Request Info

    Webinar on Lineament Analysis- The Modern Way to Look For Ore Deposits

    Overview: We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. Even over new areas with limited or nonexistent geological information we are able to help you concentrate your exploration efforts to keep your budget in the black. Behind our method lies the well documented fact that most ore deposits are directly related to or controlled by tectonic structures within different geological environments. After identifying the main tectonic structures and lineaments on the basis of sat-photos, aero-photos, infrared, radarsat, landsat, geophysical and/or geochemical fields, DEM or topographic maps, the number of these structures and their intersections are digitized using an appropriated grid and combined with the available geological, geochemical, or geophysical information.
  • 7 Request Info

    Webinar on How to Analyze Financial Statements

    Overview: Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Why should you Attend: Accounting and finance is supposed to be the international language of business. If so, then why do we struggle so much to make sense of the numbers? Speaker Profile: Miles Hutchinson is a CGMA and experienced businessman. He has been an auditor with PriceWaterhouseCoopers and the Chief Financial Officer of a $1 billion real estate development company. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1Ou06uD
  • 8 Request Info

    Webinar on Analytical Instrument Qualification According The New Revision of USP 1058

    Overview: The first version of USP <1058> has been released in 2008. Since then it has evolved as the global standard for analytical instrument qualification, despite of some deficiencies of the first version. Areas Covered in the Session: Scope and principles of the new revision. Changes to the existing chapter Approaches for risk based qualification Who Will Benefit: QC managers QA managers and personnel Analysts and lab managers Speaker Profile Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1L4WgHV
  • 9 Request Info

    Webinar on Cyber Security Mitigation and Response Risk Assessment

    Overview: An organization's security policy and controls must be adaptable to emerging threats in today's world. The assessment of security threats is ongoing, and must be mapped against the adequacy and existence of security controls. Who Will Benefit: CISO CSIO CEO Risk Managers Auditors Speaker Profile: Ms. Michael C. Redmond PMP, CEM, FBCI, MBCP, MBA, PhD, is CEO of Redmond Worldwide, an International Consulting Company. She is a Certified Project Manager, Certified Business Recovery Planner; Certified Emergency Manager; and holds two International Master Level Certifications in Business Continuity. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1LiphzY
  • 10 Request Info

    Webinar on Development and Implementation of an External Auditing Program as part of a Pharmaceutical Manufacturing Quality System

    Overview: The presentation will explain the need and implementation of a pharmaceutical manufacturing external auditing program as part of an overall GMP compliant Quality System. Why should you Attend: The use of chemical and material suppliers, contract manufacturers and contract testing lab is integral in today’s pharmaceutical manufacture. With ever increasing diversity of WW suppliers and complexity in the regulatory and scientific realm of pharma manufacture. Speaker Profile: Joseph Habarta Ph.D. is founder and principal of J. Habarta Consulting that provides specialized consulting and assistance in the areas of international GMP and quality for the biotechnology and pharma industries. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1OFoeuk
  • 11 Request Info

    Webinar on Driving a Quality-Lean Steering Committee

    Overview: This session demonstrates how to develop, manage, and implement an effective quality Lean Management System (QLMS) steering committee. Attendees will observe the development of the key components of a steering committee. Why should you Attend: Medium to large-sized companies often need an oversight group build into their business culture to help lead the implementation of quality and lean systems. Usually, this is in the form of a Steering Committee. Speaker Profile: Jd Marhevko has served as Vice President of Quality and Lean for Accuride Corporation since April 2012, having joined the company as Vice President, Quality in January 2012. She has been involved in Operations and Quality/Lean/Six Sigma efforts across a variety of industries. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1NLnbr
  • 12 Request Info

    Webinar on How to Respond to an FDA Investigation: What happens when the FDA threatens to shut you

    Overview: An FDA investigation can lead to observations requiring remediation, disruption of your business, loss of revenue and enforcement actions up to and including having your plant shutdown. Why should you attend: How would you respond to an FDA investigation? It could be a 483 observation, a warning letter, or a Consent Decree, all of which will impact how you carry on your business while under investigation. Speaker Profile: Drew Barnholtz serves as an outside general counsel and compliance officer for skilled nursing facilities, hospice providers, home health providers, physician practice groups, durable medical equipment companies, pharmaceutical and start-up businesses. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1j8Ha7T
  • 13 Request Info

    Webinar on Forecasting for Profit: The Basics

    Overview: This webinar will cover the basics of creating a model to forecast variables that are relevant to a business such as product demand or price of an important input. What are the steps to formulating a forecast model? How do you estimate a model? What are the potential pitfalls in formulating and estimating a model? How do you determine which model formulation performs best? How do you test your model? What do you need to do once you have built your model? Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/Forecasting-for-Profit-The-Basics
  • 14 Request Info

    Webinar on Predictive Warranty using Paynter Charts

    Overview: This session shows practitioners how to develop and create a Paynter Chart for predictive warranty management. Attendees will see how to actively utilize representative return data, observe the construction of a sample Paynter and then observe the results of the predictive analysis. Successful examples will be shared. Attendees will walk away with a model that they can apply to their own organizations while learning how to mitigate business cost exposure. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/Predictive-Warranty
  • 15 Request Info

    Conference about Performance Evaluations May be Hazardous to Your Company's Success

    Overview: This program was developed for leaders at all levels of an organization. It merges the topics of risk management and employee performance evaluations into a solution for better employee performance and loyalty. Why should you Attend: Even though the performance evaluation is a tool for elevating employee effectiveness, it rarely does that. Even worse, many managers and supervisors hate to give evaluations. Therefore, a transformation is needed and this webinar delivers one.
  • 16 Request Info

    Webinar on Change? It's Painless When You Do It Artfully!

    I have been presenting on the topic of change management since 1996. The source for this material is CHANGE MANAGEMENT FOR ACCOUNTING AND FINANCE PROFESSIONALS, published in 2015. This material has been road tested and is highly rated. Why should you Attend: All too often, employees and managers alike waste time applying bandages to long-term, lingering problems. However, once you understand the tools that can free up everyone's thinking, employees are able to come up with creative and lasting solutions.
  • 17 Request Info

    Webinar on Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

    Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® requirements can be met. For example, the FDA is widely using Excel® and complies with its own regulations.
  • 18 Request Info

    Webinar on Metrology: Statistical Analysis of Measurement Uncertainty

    The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias.
  • 19 Request Info

    Webinar on Current Status of biosimilars in US, Europe and Canada

    Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe. Finally, we will address Europe and where the landscape is in terms of approval and market accessibility. We will address an interchangeability study ongoing in Denmark and new legislation in France using public policy to drive use of biosimilars. We will address upcoming patent losses, and what is known about current development of new biosimilars.
  • 20 Request Info

    Webinar on Calibrating the Human Gage: Attribute Agreement Analysis

    A review of basic AAA analysis. Will cover the 3 basic types of agreements: Agreement with oneself, Agreement to a peer, Agreement to the standard. Both the "Statistical AAA" and the Kappa value will be reviewed. Confidence levels for the result bands will also be reviewed. Incorporation of AAA into the Control Plan and frequency of "calibration" will be reviewed. Session attendees will observe the step by step actions taken to undergo an AAA and its iterative results. A review of the 3 basic types of agreements will be conducted.