Both Web-based Seminars

Learn the Essentials of Digital Design at UCSD Extension - Online Course A continuation of Digital Design Essentials A. Students will explore advanced applications of typography and color to improve upon and achieve effective visual communication. In addition, students will evaluate the properties of paper and its effect on the outcome of printed publications from an aesthetic and technical standpoint. Design projects will be developed working with real-time clients  more...

The Interactive Agency Emerging Media and Design - Online Course ...and advertising worlds are quickly moving to digital with both online and offline campaigns being directly impacted by emerging media channels. Led by Digitaria Interactive Executive Vice President Warren Raisch, this course is intended for creative individuals from digital arts, gaming, and immersive media who want to learn about emerging media from a digital perspective. First hand knowledge  more...

SEXUAL AND UNLAWFUL HARASSMENT PREVENTION FOR EMPLOYEES Damages for Sexual and Unlawful Harassment Prevention claims can be in the millions. Courts have made it clear that an employera ™s best defense is to have a Sexual and Unlawful Harassment Prevention policy and provide training to managers and employees on that policy. This engaging, informative and fun on-line liveSexual and Unlawful Harassment Prevention webinar will provide  more...

TOP 10 FMLA and ADA MISTAKES EMPLOYERS SHOULD AVOID Learn how to avoid the pitfalls of the FMLA and ADA. Get the latest on the Amendments to the FMLA and ADA as well as the Department of Labor revisions to the FMLA Regulations. Stay Informed! This one-hour live on-line webinar provides all the information that you need to know to ensure compliance with the FMLA and ADA. Learn how to recognize a serious health condition and how to designate that  more...

Top Tips To Prevent Workplace Violence in your Workplace ...nce training audio conference webinar that is helpful for both private as well as public employers. It is also fully compliant with the New York State Workplace Prevention Act that requires workplace violence prevention training for all public employers. This Workplace Violence Prevention Training Audio Conference Webinar will provide you with a definition of what constitutes workplace violence  more...

Top Tips For Managers to Prevent Harassment in your Workplace ...th discussion on other types of unlawful harassment under both federal and state law. Managers who attend HR Learning Center's sexual harassment training webinars will review the heightened responsibilities they have with regard to unlawful harassment in the workplace and will fully understand their obligations with regard to their legal responsibilities as managers. The course incorporates  more...

Documentum E20-120 Training This training includes: Documentum Fundamentals Documentum Development Documentum Administration. Documentum Foundations Classes, Documentum Foundation Services, Process Builder, Forms Builder. We also give training on Documentum 6. 5 with all new and advanced topics being covered. This is done both in physical and online mode. Trainer are all EMC certified professionals and working in  more...

Documentum 65 Training This training includes: Documentum Fundamentals Documentum Development Documentum Administration. Documentum Foundations Classes, Documentum Foundation Services, Process Builder, Forms Builder. We also give training on Documentum 6. 5 with all new and advanced topics being covered. This is done both in physical and online mode. Trainer are all EMC certified professionals and working in  more...

SOA BPEL Online Training Online training in Oracle SOA BPEL SOA is the latest buzzword in the industry. The reason for its popularity is the fact that it can help bind applications easily - from SAP to Oracle Apps to Siebel to PeopleSoft to Legacy Systems to .Net systems - now you can develop applications that span all the above and more. That too, using industry standard protocols like WSDL, HTTP etc. The idea is  more...

Managing Difficult People Training This Managing Difficult People training course teaches students to address difficult people according to their specific behavior. Students will have the opportunity to meet with several Marketing Department team members to address their difficult personalities, follow the guidelines for managing difficult people to decrease the department ' s turnover rate and meet the release date for a new  more...

Java Web Services Training ...d clients. JAX-WS is central to the course, and we cover both WSDL-driven and Java-driven development paths, as well as message handlers and attachment support. With the new Provider and Dispatch APIs, it ' s now much easier to integrate SAAJ, JAXB, and JAXP code into services and clients, and we explore these strategies in depth as well. (For training within the J2EE 1.4 environment, and  more...

Java Swing Training ...ing the framework effectively. Event handling is treated, both handling AWT-style events, such as action events from button clicks, and handling events fired by the model that lies under a particular control. In the second module, more sophisticated and powerful controls are studied: the tree and table controls. Each is presented in a separate chapter, allowing students to dig into the  more...

Introduction to Internet Technologies You use the Internet regularly, for both work and personal purposes. But now, for various reasons, you want to learn about the technical side of the Internet: What constitutes the Internet? How is a website developed? What are the emerging trends and technologies on the Internet? In this course, you will examine the technical aspects of the Internet.  more...

MOC 4994 - Introduction to Programming Microsoft .NET Applications with Microsoft Visual Studio 2005 This .NET training class enables introductory-level developers who are not familiar with the Microsoft .NET Framework or Microsoft Visual Studio 2005 to gain familiarity with the Visual Studio 2005 development environment. Students will also learn basic skills using either Microsoft Visual Basic or Microsoft Visual C# as a programming language.The target audience for this training class includes  more...

MOC 4994 - Introduction to Programming Microsoft .NET Applications with Microsoft Visual Studio 2005 This .NET training class enables introductory-level developers who are not familiar with the Microsoft .NET Framework or Microsoft Visual Studio 2005 to gain familiarity with the Visual Studio 2005 development environment. Students will also learn basic skills using either Microsoft Visual Basic or Microsoft Visual C# as a programming language.The target audience for this training class includes  more...

SQL Server 2005 Analysis Services (SSAS) Training In this SSAS training course, you will learn how to use Microsoft SQL Server 2005 Analysis Services (SSAS) to design and implement OnLine Analytical Processing (OLAP) cubes and data mining models to support Business Intelligence (BI) solutions.This SSAS course includes concepts, procedures and practices based on real-world experience giving both the novice and experienced SQL Server 2005 developer  more...

MOC 5927 - Microsoft Office Project 2007, Managing Projects This Microsoft Project training class provides students with the knowledge and skills to build, maintain, and control well-formed project plans.This is the first class in the Microsoft Office Project 2007 Official Curriculum series and serves as the entry point for other Microsoft Official Curriculum (MOC) courses covering Microsoft Office Project 2007 and the Microsoft Enterprise Project  more...

Early Intervention Field Trauma Training ...n/ self-care strategies will be addressed. This course is both didactic and experiential. Emergency Site Management System will be reviewed. WHO WOULD BENEFIT FROM PARTICIPATION? This certificate will benefit first responders (e. g., fire/ rescue, emergency medical services, law enforcement, etc.) as well as mental health and health care professionals. Participants will: a Learn to  more...

Manufacturing Opportunities in Costa RicaGateway to Enhanced Productivity and Lower Manufacturing Costs For North American companies looking for solid manufacturing capabilities at a low cost; or looking for a high productivity manufacturing location, Costa Rica offers some outstanding benefits. The Central America country of Costa Rica is more than a beautiful landscape in the middle of Latin America. It is also a country that boasts one of the most attractive industrial climates anywhere in  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...

FDA Compliant Practice for Labeling and Off-Label Communication Through Social Media - Webinar By GlobalCompliancePanel ...rms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). This webinar will also discuss the FDA proposed and recommended practices for responding to both non-public and public unsolicited requests made through emerging electronic media (e. g., social media or other public electronic media). In addition, several public comments will be  more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar GlobalCompliancePanel The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. Tuesday, May 22, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Scale-Up Cycle Transfer and Maximum Throughput Capability for Lyophilized Products - Webinar By GlobalCompliancePanel Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing. Cycles that have been designed on development-scale equipment, and are producing acceptable product, can suddenly start suffering from both physical and chemical instability when scaled-up to a larger freeze-dryer, or transferred between production  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, May 1, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Using Statistics to Determine Sample Size - Webinar GlobalCompliancePanel ...he statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process  more...

Validation and 21 CFR Part 11 Compliance of Computer Systems - US Seminar 2012 at San Francisco Overview: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company an the industry, and provide  more...

FDA Compliance for Drug and Medical Device Labeling and Off Label Promotion What is Acceptable or Not Acceptable - Webinar By Gl Overview: This webinar is intended to discuss the best practices for disseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). Wednesday, March 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Supply Chain Integrity and Security - Webinar By GlobalCompliancePanel The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar By GlobalC This 90 minute live, interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, December 6, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Best Practices in Complaint Management - Webinar By GlobalCompliancePanel Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. Wednesday, November 2, 2011 10: 00  more...

Working with the Pharmacopeias and Compendia - Webinar By GlobalCompliancePanel Every developed country has a pharmacopeia, including the European Union. This webinar will explore the function that the pharmacopeias play in the regulation and quality control of pharmaceutical products. The pharmacopeias play a key role in setting standards for individual pharmaceutical products. These standards are both for the physico-chemical properties of pharmaceuticals and for the  more...

Calculating Overtime Correctly - Webinar By TrainHR ... be severe with the possibility of fines, imprisonment or both! Add civil suits to the mix and the results can be devastating to any business no matter how 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  more...

Treatment Planning Non-Surgical Periodontal Therapy Cases - Webinar By mentorhealth This one hour interactive webinar introduces both dentists and hygienists into the world of non-surgical periodontal therapy. Thursday, November 3, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Excel Spreadsheets and FDA Device Regulations - Webinar By GlobalCompliancePanel This seminar 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. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

The Drug Development Process - From RD to Commercialization - Webinar By GlobalCompliancePanel In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...d for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1: 2006 and ISO 11137-2: 2006. In this one hour seminar you will obtain a  more...

Good Deviation Practice what you need to know-BY GCP This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/ CAPA system and thorough investigations  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits This webinar details both regulations and provides details for implementing computerized systems  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a ...nsibilities of employers. This practical workshop address both the legal and psychological issues that often arise, such as confidentiality, fitness for duty evaluations, when and why to drug test, the relationship between conduct problems and mental illness, and how to directly address mental health problems with managers and employees. Why you should attend: Rrisk of litigation if  more...

Document Retention and Destruction ...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 compliance. Effective Human Resource  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...

HR Metrics for the Human Resource Executive by TrainHR In this webinar we will discuss measurements and ratios that will be meaningful to the Human Resources Department and the Executive Team in determining successful use of human capital. Human Resources uses both left and right brain thinking to achieve its objectives and key metrics for both will be covered. We will also give you practical ongoing measurement tools that should apply to all types  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

Document Retention and Destruction by TrainHR ...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 compliance. Effective Human Resource  more...

Product Recalls - Planning and Conducting Food Recall - Webinar By GlobalCompliancePanel Creating an effective Product recall process that will protect both the consumer and company's/ brand's reputation requires careful planning and active involvement of each involved department.  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...mentation Practices plus see examples of these practices (both good and bad!) as they apply to the pharmaceutical laboratory. Why Should You Attend: Discover what the FDA and EU regulations say about documentation Learn what your signature and/ or initials mean on a document See how to handle and manage data entry and errors Review "Do's" and "Don'ts" of documentation  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...ces can further concurrent development and/ or updates to both Areas Covered In the Session: * The U. S. FDA's DHF * The EU's MDD and the Technical File / Design Dossier * Design Control vs. a Product 'Snapshot in Time' * DHF "Typical" Contents * TF / DD Expected Contents * Parallel Approaches to Documentation -- Teams * Future Directions * FDA and  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...S compliance audit activity and enforcement penalties are both increased, especially in instances of willful neglect of compliance, if, for instance, your organization hasn't adopted the complete suite of information security policies and procedures needed for compliance. Learn what it takes to get in compliance and stay there, even as your operations and environment change. Find out what  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...l. Keeping your information well controlled can help with both. * Find out about how you can discover where payment card information is and is not needed, and how to keep it to a minimum so you can limit your exposure to the PCI requirements * Do you know what to do if your information security is breached? Learn who needs to be notified and why. * Learn about the latest changes  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...al Regulations and the Principles of GCP are important to both sponsors and CROa ™s / investigator sites. See how compliance with the Regs and Good Clinical Practice will ensure quality data, speed up the review process, and decreases the costs to sponsors. This Webinar addresses the obligations of sponsors, monitors, and investigators who conduct and verify clinical research that is  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...f the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The billions of dollars spent by industry  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel ...o do just that via an electronic media is understood. For both, electronic signatures and electronic records, the organization shall comply with the Part 11 regulation. Areas Covered in the Session: * Short and quick overview of the Part 11 regulation * Detailed description of HOW TO prepare for an FDA inspection * When and Where Part 11 is in scope or the scope of the  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...ackaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Areas Covered in the Session: * Understand how and why CAPA is tied in to product complaint investigations * Examples of tools currently being used to conduct investigations * How  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...oduct is Part 11 compliant, this teleconference will give both old hands and new staff the practical information needed to understand the applicable regulations and solid methods to document compliance. * FDA inspectors are now being trained to evaluate software validation practices. * Increasing use of automated manufacturing and quality systems means increased exposure. * Most  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...idation practices require many documents that are managed both electronically (in multiple systems) during development, review, approval and manually once the validation project is concluded. This practice lends itself to possible non-compliance due to human error, procedures not being properly followed and corruption of hard copy validation evidence. These issues are prompting life-science  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...n Practices plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena. Why you should attend: The Learning Objectives of this presentation include: * Discover what the regulations say about documentation practices * Learn what your signature and/ or initials mean on a document * See how to correct errors and omissions in data  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...iew: 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...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel ... attend: The equipment Program is a critical component of both GMP and GLP laboratories. It contributes to the quality and therefore reliability of the generated data which is required for critical for go-no-go decisions. An effective Equipment Program is also an expectation in GLP and GMP laboratories. Areas Covered In the Seminar: * FDA requirement for Equipment systems *  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...fective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean 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  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ... Why you should attend: This presentation will address both the regulatory and products liability consequences of off-label promotion. It discusses the fundamentals of off-label promotion and provides risk management tips to help companies prevent off-label promotion. Areas Covered In the Seminar: * Off-Label Use of Drugs * Overview of Current Legislation and Regulations  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...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 you want. We explain the built in Validation tools and how to use them to prevent the user from entering incorrect data.  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ... result is a validation effort that can be optimized from both a cost and time perspective. This webinar will provide a methodology for developing quality requirements for PDMA systems and will examine the benefits of leveraging those requirements to plan and drive the validation effort. Why should you attend: With the FDA announcing that it will be performing Part 11 audit this year and  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...macy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription. Today's pharmacists will need to familiarize themselves with the stringent laws and regulations enforced by the Drug Enforcement Administration (DEA) through their Office of  more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel ...ymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement each other. Additionally the differences and limitations of both methods will be illustrated and the appropriateness during  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...Both the U. S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e. g., MS-Excel and MS-Word, 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  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...ut FDA continues to find violations of these regulations. Both large and small manufacturers have been cited by FDA investigators as a result of directed and routine inspections. 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  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...etailers have about wholesalers and processors have about both. Where do buyers go to determine the food safety level of suppliers? The peanut outbreak in 2009 impacted over 300 processors and caused the recall of over 2100 different products. Hundreds of millions of dollars were lost to the entire industry. Insurance companies and the federal government are focusing on assessing food safety  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...dical device and In Vitro Diagnostic manufacturers. It is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and fundamentals for a better understanding on how to prepare and submit your application to ensure regulatory and compliance success. Those who will benefit include professionals in R&D, development,  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...o. Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information - the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked. Why you should attend: The HIPAA Privacy and Security  more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel ... Utilization of Science in Regulatory Decision Making. Both Preliminary Reports and Recommendations were published August 2010, and stakeholders / industry is invited to comment. They recommend action on the part of both the FDA and industry. Clarification of terms and expectations. A review of these reports and other goals of the Agency that have already been translated into action in the  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ...n use today and simple techniques you can apply to reduce both legal risk and the risk of financial crimes, and guidelines to institute a systematic approach to operational risk. Areas Covered In the Seminar: After attending this session, you will be able to: PART ONE * Identify the major categories of Risk according to Basel * List the seven major categories, 20 categories,  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...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work  more...

Using Statistics to Determine Sample Size - Webinar by GlobalCompliancePanel This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain  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...

Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by Global ...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 supplier evaluation and assessment, and provide cost efficient,  more...

Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar by GlobalCompliancePanel Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol.  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 ...fective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean 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  more...

Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel ... 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 analytical performance characteristics and acceptance criteria and summarizes  more...

Best Practices in Complaint Management - Compliance Webinar by GlobalCompliancePanel ...his feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and  more...

Treatment Planning Non-Surgical Periodontal Therapy Cases - Webinar By mentorhealth This one hour interactive webinar introduces both dentists and hygienists into the world of non-surgical periodontal therapy. Tuesday, April 10, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Excel at Filing - On-Demand Webinar The computer is an excellent organizing tool and yet the last thing clients want to do is buy more software. In this popular webinar, Certified Professional Organizer ® Debra Milne takes you through the different ways Microsoft Excel ® can be used to create an electronic filing system including electronic filing practices; printing file inventory lists; searching and tracking files;  more...

Complete Java Training ...months * Timing: Every alternate day in week day and both week ends. * This course is Free for new students for first 2 weeks. * Pricing: 990$ (Including taxes) (Saves you 300$). * We beet all our competitors prices. * Register now Complete Java & J2EE Training Course Details * Core Java Training * Java/ J2EE Web Training * J2EE & Frameworks  more...