Company Web-based Seminars

Data Integration for Data Mining with Talend Open Studio OS ...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 three classes of data operations: Extraction (E), Transformation (T), and Loading (L). The ETL operations included in the course are: Extraction of data from multiple input  more...

Introduction to Statistics Using Common Software Packages ...urse at our office, a corporate course on location of the company or a location of their choosing, and remote (online) courses. Resident Course: Date: This course is run twice a month but can be conducted at different times during the week; contact us for arrangements. This course can be conducted online and in Colorado. Corporate Course: If your company would like to have a course  more...

From Hiring To Firing What Every Manager Needs to Know ... 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 addition, USERRA applies to employers with one or more employees and the ADA applies to employers with 15 or  more...

Employee Handbooks Dos and Donts ... Learning Objectives a How to protect your company from the top mistakes that employers make in drafting employee handbooks a How to prevent claims of implied contract a How to avoid using language that can give rise to claims of breach of implied contract a What are the essential disclaimers your employee handbook should contain a How to have a well drafted anti-harassment  more...

Top Tips For Managers to Prevent Harassment in your Workplace ...rse incorporates a review of what should be included in a company's Sexual and Unlawful Harassment Policy, including the applicable managers to whom sexual and unlawful harassment complaints should be reported. HR Learning Centera ™s Anti-Harassment Training Seminar provides an in-depth look at sexual and unlawful harassment including a definition of sexual harassment, discussions of  more...

Tips To Avoid Liability When Terminating Employees ...ar is a must for all employers. Learn how to protect your company and yourself in this workplace law guide to terminating employees that provides some top tips for avoiding liability. Nothing causes more problems for employers than terminating an employee. Attend this informative one-hour seminar to learn how to avoid the top mistakes that employers often make when terminating employees.  more...

TOP TIPS TO AVOID LIABILITY WHEN FIRING EMPLOYEES This live on-line webinar will provide all the information your managers need to know to prevent liability when terminating employees. HR Learning Center will provide tips on providing documentation to support your termination decision and avoid claims of discrimination when terminating empoyees. We will also provide information on ways to avoid claims of wrongful discharge and breach of implied  more...

QuickBooks 2009 Training ...a small business. Students will learn how to set up a new company, work with lists, set up inventory, process invoices, work with bank accounts, process payments, enter and pay bills, and use online banking. In addition, students will learn how to customize forms, create reports and graphs, track and pay sales tax, handle payroll, write letters and more. In addition to QuickBooks 2009, this  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 8399 - FRx 6.7 Report Design Essentials I ...p you create new reports, and distribute and analyze your company ' s financial information. You learn about basic foundational skills, complex calculations, drag and drop reorganization, rounding adjustments and account sets. A thorough understanding of these topics allows you to easily design and maintain standard and essential reports your organization needs to understand its financial  more...

MOC 8400 - FRx 6.7 Report Design Essentials II ...ng to external worksheet data, linking row formats, multi company consolidations, currency translation reporting and cash flow. A combination of instructor guided exercises and practice tutorials allow students to master their report design skills.A thorough understanding of these topics allows you to master the advanced report design techniques necessary to create a more comprehensive suite of  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...

Budgeting Training: Budgeting Basics ...udgeting is covered, from preparing income statements and company expense reports, to developing your own personal plan. Students learn about different types of budgets and the elements of a successful budget. Students also learn how to create a budget, analyze and compare budgets, and create operating and manufacturing budgets. Course activities also cover the basics of capital budgeting,  more...

Business Accounting Training This online business accounting training class introduces students to the fundamentals of business accounting. Students learn about current assets, long-term assets, intangible assets, and natural resources. Students also learn about the different types of liabilities, managing those liabilities, and calculating the time value of money. Course activities also cover calculating the present value,  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 ...use 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 surely balloon at the same time customer shortages increase. When forecasting is an afterthought, no one is  more...

How to Factually Evaluate Critical Supplier Performance and Risks ... spending, improved factory productivity, and accelerated company profits. - Are a few of your critical Suppliers performing poorly & creating unreasonable supply chain risks for your company? - Are you concerned about your critical Suppliers' economic viability in these difficult times? - Are you worried that your core Suppliers cannot meet your cost reduction goals? - Have you  more...

Preserving Precious Capital Attacking the SEVEN Most Significant Capital Wasters in Your Company Times are tough and capital preservation is at the top of every executivea ™s priority list. But specific techniques necessary to rapidly eliminate waste and reduce operating costs can be difficult to define and even more difficult to implement. If you manage ANY type of an organization, you have waste which steals precious capital from your enterprise. Now, more than ever, it is important  more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing You are invited to attend the Manufacturing Executive Institutea ™s FREE February 2011 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...

How to Calculate the Impact on Total Factory Costs from a One Percent Change in Planned Load ...houghts and techniques, specifically focusing on how your company can come to an understanding of what a 1% change in planned load means to profitability and enterprise value. We will discuss: a How to calculate the impact on profits derived from a 1% change in annual planned load. a What costs are included in variable, semi-fixed and fixed cost categories overcoming myths  more...

Keeping Work Order and Purchase Order Due Dates Accurate - A Key to Production Planning Success ...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...

Building a Cost Reduction Curve to Estimate Future Raw Material Prices ...ompanies. 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 reducing sourced material costs is to start planning for raw material price reductions the day the  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 ...ic 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 ...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 clinical studies in the U. S. and EU. Tuesday,  more...

Responding to FDA 483s - Webinar By GlobalCompliancePanel Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. Wednesday, November 30, 2011 10: 00 AM PST | 01: 00 PM EST  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 ...ow large or small! Learn how to protect yourself and your company by joining renowned payroll expert Vicki M. Lambert in this information packed event! Areas Covered in the Session: How to calculate the regular rate of pay The eight narrowly construed exceptions to inclusion of payments in the regular rate When you must include a bonus in calculating your employeea ™s overtime  more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel ...the Session: What is a CCMP and how is it valuable to my company? What topics are covered in the CCMP and to what extent? How is the CCMP controlled and updated? How is the CCMP implemented? Who contributes to the CCMP? Who Will Benefit: QA personnel Regulatory personnel Operations managers Microbiologists R&D Scientists Validation Personnel Training departments Consultants  more...

SAP FICO Online Competency Development Training program .... Chart of Depreciation/ Depreciation Area/ Assign COD to Company Code 24. Assign Input tax indicators/ Account Determination/ Asset Class/ Number range interval 25. Define Asset Class/ Number range interval/ Creation of Asset G/ L accounts 26. Accumulated depreciation accounts/ Sale of Asset/ Loss on sale of asset/ Scrap G/ L account 27. Screen Layout- Asset class/ Asset master/  more...

Business Analyst Competency Development Program ...aran 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, reduce costs, manage risk & regulation and leverage talent.  more...

FDA Inspections - Dos Donts - webinars by gcp 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.  more...

FDA Inspections - Dos Donts 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.  more...

W-2s 1099s Independent Contractors Protect Yourself with Proper Classification by TrainHR Understanding proper classification requirements and helping to guide your company through this sensitive and important decision can be one of the most valuable and beneficial services that payroll departments can provide to the organization. Can you be relied upon to make those determinations correctly?  more...

Document Retention and Destruction ...olved until the case is resolved and always refer to your company attorney for guidance. For your protection and convenience well-managed record-keeping not only aids in compliant administration, but gives you confidence in knowing you are prepared for any audit of your records. Areas Covered in the Session: Where records should be kept What belongs in a personnel file Keeping and  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 ... reduce conflict , convey legal obligations, protect your company by covering employer rights, notify employees of recourse systems, clarify expectations, consequences and rewards, reduce misunderstandings, save time and convey desired culture and behavior. Why you should attend: Human Resources policy is an important communication tool which can In Human Resources and as a manager, you will  more...

The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel ...10(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 between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the  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 ...ajor 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 V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...ta of incoming, in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? Areas Covered in the Session: * FDA Quality Systems  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...ngle complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...ur suppliers Why should you attend: Imagine this! Your company uses acceptance sampling in your manufacturing process and your manager asked to make sure it is cost effective. She also knows there is some risk associated with sampling, but she admits she doesna ™t completely understand it. You now have a new assignment; assure your manager that you have good balance between risk and  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ... regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have a procedure in place that describes  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...ll as a "refresh" overview on how to register your device company and list your device(s) correctly and meeting requirements and expectation regardless of the outcome of the Proposed Rule. Areas Covered In the Seminar: * When and how to register and list * Review the four proposed changes to FDA's device establishment registration and device listing regulations * Proposed  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ... that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ... * Discuss the therapeutic areas with experts in the company and externally such as key opinion leaders, patient groups may also be of help * Decide on the study design potential locations for the study (eg which countries have a high incidence of the disease, where do you propose to market the drug * Identify potential locations for the study (eg which countries have a high  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...d evaluate the effects that this call for change has on a company and its selection, audit, use and on-going relations with its suppliers of services and products / components. How can companies address the FDA's stated desire to require "on-site" audit of all Pharma suppliers? Expectations for meaningful, results driven actions that addresses and resolve any underlying compliance issues or  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...duct design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to "toughen" its  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...d evaluate the effects that this call for change has on a company and its change control policies and systems. Change can be beneficial, but is often the cause of new and even worse problems than those the change was designed to eliminate. It can be the root cause of a major problem, cGMP "entropy". Proper change control is required to resolve any underlying compliance issues or product  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...lso discuss proven methods to prove to the FDA that known company cGMP deficiencies should not be a major concern to the Agency, and which may 'eliminate' the possibility of a deserved Warning Letter. Why you should attend: The FDA says it's getting tougher. Recent audits and other enforcement actions indicate that's true. The past ways of doing things is not acceptable. The Agency continues  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...tions. Failure to comply can result in the FDA citing the company for a violation, i. e., listing it on an FDA Form 483 Inspectional Observations. The FDA may even escalate these observations to a Warning Letter. Unfortunately, many well meaning intentions may fail to satisfy the regulations. For example, a manufacturing engineer may recognize that an Excel spreadsheet could reduce the  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...r 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 approvals * Minimize nonconformances * Reduce rates of batch  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 ...l 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 industry and what it  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...ord, or similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ...me is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line. Why you should attend: The FDA expects companies to manage projects formally - to include regulatory requirements, design and/ or change control, with consideration of all applicable standards. The EU MDD and their notified bodies are no  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ...tial SEC issues relative to social media marketing * Company-sponsored blogs versus outsider forums * Dealing with on-line critics * Other defensive activities (monitoring your online presence) * Policies and procedures for corporate control Who Will Benefit: * Healthcare marketing professionals * Healthcare CEOs, CFO, and COOs * HIPAA officers *  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel ...e 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 course for personnel to meet program training requirements. Why you  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...tions. Findings include lack of procedures, not following company procedures, as well as not filing reports in a timely manner as required in the regulations. FDR considers violations of the Medical Device Reporting regulations to be serious and often issues Warning Letters to manufacturers for these violations. Areas Covered in the Session: * Review the FDA's Medical Device Reporting  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ... Why you should attend: Management from any food handling company interested in learning a basic thought process that will help them to reduce the risk of being caught in a food recall should consider attending. Which food suppliers represent high risk? Which ones are likely to cause an outbreak associated with E. coli or salmonella? Should your company buy from high risk suppliers? How do you  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... * When it is and is not required if you are a device company * Exemptions to the submission process and special considerations * How to locate a "predicate" device and go through the content and format of the 510(k) * Understand the De Novo process and the expectations for possibly marketing a low risk device * Understand the potential impact of FDA's proposed changes  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...ta of incoming, in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? Areas Covered in the Session: * FDA Quality Systems  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ...hat inspectors are looking for * How to prepare your company for the upcoming inspections * Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations * How to fill gaps short term * Developing a program for long term * Creating the right documentation to satisfy the inspectors * Most likely next steps after  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...atents and Trademark Considerations * Beginning Your Company Involvement in Japan o Local Office and Personnel Requirement Options o Language Requirements o Possible License Types * Objectives of the Rules Governing Medicinal Procedures o Market Authorization Holder Overview * Life Science Regulations and the Regulatory Processes in  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel ...s 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 a great extent, but not completely. This webinar sets forth the requirements for recalls, removals, and market corrections, and provides recommended practices. Why should you attend: There are certain circumstances in which a report from  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...ew: 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) need  more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel ...dical devices and ICH Q10 re: pharmaceuticals; multi-site company operations, and the supply chain; trends evident in 483 observations and Warning Letters, will also be reviewed. Companies need to evaluate their own systems and future submission in light of this new emphasis. Anticipation and addressing of weak spots proactively will further prove a company is "in control", assist in timely  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 ...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 and  more...

Microbiological Foodborne Threat - Risk Mitigation and Crisis Management - Webinar by GlobalCompliancePanel ...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 and  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...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan 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 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 V&V protocols. How to  more...

Value-Adding Internal Auditing Learn how to get your Internal Audit System to promote improvements and add real value to your or ...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 ability to audit in a professional and knowledgeable  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 ...ity 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 program, your company needs an  more...

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel ... that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their  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 ...ucts 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 arrival of an investigator for an inspection can still be an intimidating experience. The inspection can be less traumatic if the site  more...

Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel ...n, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA and Health Canada. This webinar explains the reason and purpose of USP chapter and helps you to interpret what is required for verification of pharmacopeia methods to satisfy regulatory requirements. It discusses how to select appropriate  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 ...g 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 the biggest data breaches 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 ... 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 of email and disaster recovery. Michael Oa ™Shea  more...