For A Company Web-based Seminars

Data Integration for Data Mining with Talend Open Studio OS This course covers the many data integration procedures necessary to create a Customer Analytic Record (CAR) suitable for data mining operations. Talend OS is an Open Source tool; the client version is available for free download. The Talend company charges for the client/ server version of the tool and any support required for its installation and use. Data integration tools like Talend perform  more...

Introduction to Statistics Using Common Software Packages This course measurably increases your ability to interpret, conduct, & write comprehensive marketing reports using statistics while training using Popular Statistics software. The primary goal of the course is to be able to determine which analysis is appropriate given the question and type of data given. The course will focus on pragmatic business applications, interpretations, presentation, and  more...

PAPERLESS HR - LEGAL PITFALLS TO AVOID WHEN YOU DECIDE TO GO PAPERLESS Many companies are considering or moving towards having a paperless a HR Departmenta . This informative audio conference presented by our legal expert, Melissa Fleischer, Esq. will discuss and clarify what this means for your company. Ms. Fleischer will also provide an overview of some of the legal challenges that companies face when deciding whether to go paperless and how to avoid these legal  more...

Navigating the Alphabet Soup of Employment Law - What Every Manager Needs to Know FMLA, ADA, ADEA, GINA and USERRA. Learn how to avoid Employment Law liability under each of these statutes. Find out how each of these laws interacts with the others to ensure that your company is in full Employment Law compliance and adequately protected. Learn how to protect your company and yourself (managers can be held personally liable under most state fair Employment Laws, for example  more...

From Hiring To Firing What Every Manager Needs to Know FMLA, ADA, ADEA, GINA and USERRA. Learn how to avoid liability under each of these statutes. Find out how each of these laws interacts with the others to ensure that your company is in full compliance and adequately protected. Most employers do not know that in many states the state employment discrimination laws apply to employers with small numbers of employees such as 4 or more employees. In  more...

Employee Handbooks Dos and Donts Employee Handbooks are essential for employera ™s in todaya ™s litigious environment. They are the number one most important tool that an employer can have to protect itself from future liability. However, there are important mistakes that employers can make that reek havoc for employers. Learn what policies must be in your employee handbook as well as phrases and terms that you should  more...

Top Tips For Managers to Prevent Harassment in your Workplace The best protection is for managers to understand what their responsibilities are and learn tips to help them prevent harassment in the workplace. This interactive, informative sexual harassment prevention training, "Top 10 Tips for Preventing Harassment in Your Workplace," will provide the tips that managers should not be without. It includes a definition of sexual harassment and discussions  more...

Managing Business Risk This Managing Business Risk training course will help students identify special risk-management considerations for specific types of businesses and industries. It will also help students develop a strategic approach to risk, which, when understood across the organization, with commitment at the very highest level, can enhance a company ' s competitive advantage and contribute to the company ' s  more...

MOC 8811 - Foundation I in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Foundation training class explores the basic elements of Microsoft Dynamics GP. Topics covered during this session include: system and company setup procedures, how to use reports and inquiries, how to use SmartList to expand inquiry and analysis capabilities, business alerts, process server and tips for the user to personalize shortcuts and checklists to streamline  more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing You are invited to attend the Manufacturing Executive Institutea ™s FREE June 2012 3rd Thursday - a Operations Improvement webinar, A Case for Routine Use of Statistical Process Control (SPC) in Manufacturing. Statistical Process Control is a term that describes a process for predicting failures and methodically determining the underlying cause(s) before the predicted failures can  more...

Keeping Work Order and Purchase Order Due Dates Accurate - A Key to Production Planning Success Does your company, at this very moment, have past due work orders or purchase orders? Does your company utilize a priority planning system (MRP, KanBan, etc.) to manage the flow of materials through the factory? Does your company have a materials management organization that responds to expedite activity more than to planned activity? This FREE 1-hour webinar will present some new thoughts and  more...

Measuring Performance of Your Global Procurement Organization How to Shape Behaviours in Global Purchasing You are invited to attend the Manufacturing Executive Institutea ™s November 8th, 2011 a Global Manufacturing Enterprise Seriesa FREE webinar, a Measuring Performance of Your Global Procurement Organizationa How to Shape Behaviors in Global Purchasing.a This montha ™s powerful 1-hour webinar has 2 important objectives: 1. Define the best alternatives for structuring a  more...

How to Dramatically Improve the Quality of Your Shipment ForecastsTechniques to Improve Forecast Inputs Supply-chain professionals must NEVER stop thinking about the integrity of the shipment forecast. This is because a shipment forecast represents independent demand for company product which in turn drives the Master Production Schedule (MPS) process. Start with an inaccurate shipment forecast and a poor performing MPS is sure to follow. Continue with a poor forecasting process and inventory will  more...

How to Factually Evaluate Critical Supplier Performance and Risks Manufacturers and distributors are choosing to source significant amounts of materials and components from global suppliers and are creating substantial risks within their supply chains. Companies are discovering that sourced-material disruptions can and often do, result in dramatic and unfavorable impacts to material delivery reliability, total material cost and received material quality.  more...

How to Calculate the Impact on Total Factory Costs from a One Percent Change in Planned Load You are invited to attend the Manufacturing Executive Institutea ™s September 2010 3rd Thursday - Operations Improvement Series FREE webinar, How to Calculate the Impact on Total Factory Costs From a 1% Change in Planned Load. The largest cost driver in most manufacturing companies, outside of the cost of direct material, is underutilization of semi-fixed and fixed costs. These costs are  more...

Building a Cost Reduction Curve to Estimate Future Raw Material Prices Annual raw material spend is usually the largest cost reduction opportunity in most manufacturing companies. By reducing the price of raw material items, a company is immediately reducing its cash outflow and increasing it liquidity. Further, reducing annual spend improves gross margins and allows for a more competitive finished goods pricing strategy if needed. The trick to systematically  more...

Management Controls Under QSR and ISO 13485 - Webinar By GlobalCompliancePanel Overview: The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together." Tuesday, June 12, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND Comparing the Content and Agency Expectations - Webinar By Overview: This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out  more...

FDAs 21 CFR 11 Add-On Inspections - Recent Updates - Webinar By GlobalCompliancePanel This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. Tuesday, February 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Portfolio Optimization for Global Drug Development - Webinar By GlobalCompliancePanel Strategic portfolio planning is crucial for developing long-term company strategy. The goal is to meet strategic objectives selecting the "best" portfolio of internal and external drug development programs for funding and balance company resources including money, manpower and manufacturing capacity. Projects could be interdependent, have multiple development scenarios, and are subject to multiple  more...

The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND Comparing the Content and Agency Expectation - Webinar By G This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective  more...

How to Prepare for Manage and Follow-up to an FDA Inspection - Webinar By GlobalCompliancePanel The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance is not good, it is not the show that may close, it is YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!  more...

Calculating Overtime Correctly - Webinar By TrainHR Overview : The information provided in this presentation covers proper procedures for calculating overtime and common pitfalls involved in the process. The importance of being thorough and correct when calculating regular rate of pay to avoid massive Department of Labor penalties is also highlighted as well as its importance in avoidance of suffering damages from civil law suits. Why you  more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel Why you should attend: Manufacturers of human medical products have established myriad control programs to comply with FDA regulations regarding control of product contaminants. However, due to variable emphasis being placed on each of these control elements by FDA auditors, most manufacturers have developed their programs in a piecemeal fashion. Thus, each element in a manufacturer's control  more...

SAP FICO Online Competency Development Training program TRAINING DETAILS: Course Duration: 90 hours Training + Case Studies + 2 months Server access Training Materials: All attendees would receive a Assignment after each module, a Notes and study material for examples covered. a Access to the Training Blog Training Format: This course is delivered Online using Web and Audio Conferencing. Timing: Weekdays and Weekends after work  more...

Business Analyst Competency Development Program BUSINESS ANALYST Competency Development Program About Zarantech: Zaran Tech is a global IT training and consulting services company with one goal in mind a develop and deliver the highest quality consultants to our Clients and customer. As a consulting company, we help organizations to work smarter and grow faster. We consult with our clients to build effective organizations, innovate & grow,  more...

Document Retention and Destruction You should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in  more...

Preventing Harassment in the Workplace by TrainHR This webinar will concentrate on what is considered sexual harassment as well as covering other types of harassment in the workplace. It will review the laws protecting employees from harassment and the recourses employees have. It will define who is covered and describe the two main kinds of sexual harassment in the workplace. It will cover what should be in an effective Harassment policy, how  more...

Auditing and Administrating Human Resources Policies and Practices by TrainHR This webinar will concentrate on making sure you have current human resources policies that are in compliance with applicable laws and convey the desired practices in your organization. Policy should be reviewed and updated periodically and through this webinar you can review your current policies, clarify policies for easier administration, and perhaps add new policies others to address new  more...

The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel Overview: The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel Overview: This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel Overview: Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl Overview: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U. S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel Overview: Medical devices are classified into three classes, Class I, II, and III, based on the level of control necessary to assure the safety and effectiveness of the device. Recalls of Class II devices represent 61% of all device recalls over a review period, followed by Class III devices at 28%. This Webinar will provide a recent update on the latest trends and causes for device recalls and  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel Overview: This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running clinical trials. It will ensure you gain a clear understanding of the tools and techniques of project management for clinical trial and how they can be applied to your own pharmaceutical projects in the work place. In addition to key project management tools  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel Overview: Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel Overview: There is an on-going major shift in the emphasis of U. S. FDA cGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel Overview: This webinar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. The seminar begins with Excel methods to help ensure the spreadsheet produces the results  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an introduction to the creation, implementation, and maintenance of a Contamination Control Master Plan. Key benefits of this seminar include: * Achieve satisfactory inspections more easily * Higher assurance of new medical product  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel Overview: Where business is concerned the world is becoming a smaller place. Trade boundaries are disappearing, and many companies have subsidiaries around the world. Multi-national corporations needed a simpler way to put together their consolidated financial statements. Already Australia, most of Europe, and many other countries have adopted International Financial Reporting Standards.  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...hat benefits beside regulatory compliance can be achieved for a company? Areas Covered in the Session: * Tougher FDA and EU MDD Software V&V Expectations * Key COTS Software Apps V&V Requirements * Problem Areas * Product, Equipment/ Process, QMS and Apps Software and Part 11 Requirements * Realistic Limits of Apps Software V&V * Suggested Approaches *  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. One very simple approach  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Most sophisticated businesses use social media sites such as Facebook, MySpace, Twitter, and LinkedIn to promote their services, connect with their customers, and as a overall component of their business strategy. Physicians and other healthcare providers have begun to experiment in the social media environment, but most are concerned that the special rules applicable to the  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel Overview: A comprehensive review of an ideal chemical control program will be presented. The guidelines presented will enable your company to implement programs that are cost effective and meet or exceed the expectations of major QSR, and GFSI audit criteria. This presentation will provide not only a provide schematic for management and control of chemicals, but an interactive and customizable  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel Overview: With today's movement into more and more serious controls over food safety and security, the liabilities associated with recalls and deaths are creating new approaches to determine and reduce the likelihood of risks associated with contaminated foods. Risk assessment involves determining where and what types of risks are involved throughout any food process, assigning quantitative  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues a company's senior management and QA/ RA need to consider in their annual Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry)  more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. Examination of two recently published reports by the FDA's CDRH (devices) have identified major areas of concerns: 1) 510(k) Working Group's Preliminary Report and Recommendations, and 2)  more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success, and avoid those frustrating, embarrassing discussions of missing or doubtful data, employees recognize and must follow Good Documentation Practices (GDP). These practices apply to all pharmaceutical  more...

Process Verification and Validation - by GlobalCompliancePanel This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs. It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies. Enhanced use  more...

Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes  more...

Microbiological Foodborne Threat - Risk Mitigation and Crisis Management - Webinar by GlobalCompliancePanel As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes  more...

Transfer of Analytical Methods FDA Expectations and Tools for Implementation - Webinar by GlobalCompliancePanel Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA  more...

Value-Adding Internal Auditing Learn how to get your Internal Audit System to promote improvements and add real value to your or Auditing is a critical function of a medical product company. It provides management with information about how effectively a company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical GMP regulations and other quality standards. This course provides information to increase an auditor's  more...

Project Management for FDA-Regulated Companies - Webinar by GlobalCompliancePanel This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and ot Three of the most common tools will be discussed. One very simple approach using common Excel- or Word-type PC applications programs that  more...

Developing an Effective Supplier and Internal Auditing System - Webinar by GlobalCompliancePanel The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day. Are there going to be noncompliance? You bet. Are you going to correct these noncompliances? Only if you identify them. To ensure substantial compliance, your company needs an effective audit program for both internal and external processes. To have an effective audit  more...

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective  more...

The FDA Tripod - Clinical Trial Regulations Compliance and GCP in Drug Development - Webinar by GlobalCompliancePanel This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms,  more...

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control. However, the  more...

Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA and  more...

Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis  more...

Marketing on A Budget This workshop has helped and will help you, the small business owner, work from home parent and entrepreneur. When markeitng we are all looking for affordability as well as an effective way to market. This seminar willgo over the different areas of marketing, how to find the cost effective way to market based on your company goals.  more...

PCI Data Breaches What happened What may have prevented it What if it happens to you If your organization is struggling to meet compliance requirements for PCI, you're in good company. Unfortunately, in this case there is no safety in numbers. Criminals do not necessarily attack big companies; they go after whatever is easy. The cost of responding to a breach is getting more expensive each year. In this webinar you will learn about the current threat environment, how some of  more...

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems GlobalCompliancePanel brings a new webinar on the topic of Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems. Webinar will be on March 11, 2010. Webinar will be presented by Teri C. Soli. Mr. Soli has 25 years of diverse "Big Pharma" operating company experience. During his 30 year career he has lectured extensively at conferences, authored numerous papers and  more...

Do I E-Shred This This webinar is a primer on handling electronic information. Learn how it's stored (not too technical, I promise!) and where it resides. Learn the 10 privacy principles that form the basis for most privacy legislation and how to use them as part of your or your client's environment. If you or your clients store electronic information, and almost all do, it's critical to include handling  more...

ACT Everyday This training course replicates "a day in the life" of a busy connector who must manage a large list of customers, prospects, projects and marketing. Included in the 2. 5 hour curriculum are how to use the ACT! calendar, task list, email and letter mail merge functions, dynamic groups, company records and how to customize dashboards for a snapshot view of your action items and sales and marketing  more...

Records Management 1 - Its A Lot More Than Filing - On-Demand Webinar Records Management is a critical function in all businesses no matter what size the organization is. The larger the company the more complex records management becomes. In this first webinar of the Records Management series, learn the basics about this profession. Start to understand the terminology and the key components such as classification schemes, retention schedules, and the management  more...