Part Web-based Seminars

Introduction to SQL Training This SQL training course is designed for students new to writing SQL queries. A typical student will need to learn SQL to build applications or to generate business reports. For the most part, the SQL learned in the course is applicable to all major databases. In the few cases in which there are differences between the databases, these differences will be pointed out.  more...

SharePoint Designer Training ...Point sites and to create SharePoint master pages and web part pages. Note that in this introductory SharePoint training class, those SharePoint-specific features are not covered. If you are not specifically interested in SharePoint, but need to create web pages, please see our Expression Web Classes. Learn more about the differences between SharePoint Designer and Expression Web.  more...

Intermediate Java Training ...them to Java software design and development. The latter part of the course moves key parts of the Java SE Core API, including collections, exception-handling, logging, streams, and object serialization. The course software also includes an optional overlay of workspace and project files to support use of the Eclipse IDE in the classroom. (This requires that the instructor be experienced in  more...

Comprehensive JSP Training ...dard for common processing tasks in JSP. JSTL is a major part of the new scriptless authoring style encouraged (and enabled) by the JSP 2.0 specification. This module covers all four JSTL libraries in depth: The core actions, which support JSP expressions for JSP 1.x containers, flow control for procedural processing in JSPs, and resource access. The formatting and  more...

SharePoint 2007 End User Training In this SharePoint training class, students will learn how to fully utilize 2007 Microsoft Office system applications in your SharePoint 2007 environment. The SharePoint end user course will be walk you through all of the basic features of Windows SharePoint Services (WSS) and Microsoft Office SharePoint Server (MOSS) sites with many hands-on activities.This SharePoint 2007 course is designed for  more...

Business Problem Solving and Strategic Decision Making ...nalysis techniques, reasoning, and conclusions.The second part of the course focuses on Strategic Decision Making. Students will learn how to plan, frame, and research decisions. Students also learn how to define decisions, apply appropriate decisions frames, avoid overconfidence, deal with uncertainty, generate options and select the best one, develop numerous high-quality options, evaluate  more...

MOC 6234 - Implementing and Maintaining Microsoft SQL Server 2008 Analysis Services This SSAS training class teaches students how to implement an Analysis Services solution in an organization. The class discusses how to use the Analysis Services development tools to create an Analysis Services database and an OLAP cube, and how to use the Analysis Services management and administrative tools to manage an Analysis Services solution.This SSAS class targets people who design and  more...

Certified Eco Green Consultant Training Program GoEco Certified had developed the nations best & most comprehensive Certified Eco Consultant Training Program to help future Eco Consultants provide a valuable service within their community helping Homes/ Businesses GO GREEN! Green Consulting is a rewarding carrer that can be either part time or full time. All of the Eco Consultants are actual Certified Eco Consultants in the field doing exactly  more...

Constructing a Component Criticality Matrix A Better Way to Identify Important Components ...nizations are often responsible for managing thousands of parts that can be purchased from hundreds of Suppliers. The large number of parts and Suppliers makes it nearly impossible to manage each individual part as much as one wants to. This is why Procurement organizations rely upon stratification methods and other sorting methodologies to provide insights into GROUPS of parts. This way,  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...

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...

Excel Spreadsheet Validation to Eliminate 483s - GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Tuesday, March 20, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Excel Spreadsheet Validation for FDA 21 CFR Part 11 - Webinar By GlobalCompliancePanel This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. Tuesday,  more...

Why is Drug Induced Liver Injury an Important Mirror of Drug Safety and How to Spot this early - Webinar By mentorhealth Ferreting out which Investigational Medicinal Products (IMP) might cause significant liver injury is not an easy process partly because there is confusion about how to test for liver injury and part because these AEs are rare (in the 1: 10, 000+ area) or "idiosyncratic" in type so are not picked up in the usual drug development process testing. Wednesday, November 30, 2011 10: 00 AM PST | 01:  more...

Excel Spreadsheet Validation to Eliminate 483s - Webinar GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Tuesday, January 10, 2012 10: 00 AM PST | 01: 00 PM EST  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...

A Practical Look at Discipline and Termination - Webinar By TrainHR ...r takes a practical look at discipline and termination as part of effective performance management. You'll learn about different kinds of discipline policies and some of the legal implications of using discipline. You'll also explore some best practices for deciding: when and what kind of discipline to use, how to document it, and how to implement it. Importantly, you'll also look at how  more...

Job Evaluation Methods and Plans - Webinar By TrainHR Overview : In this program the speaker will review the purpose and types of Job Evaluation Plans, used to establish grade levels for a company's job classifications. Job Evaluation Plans such as Ranking, Paired Comparison, Whole Job Method, Hay Plan, Factor Comparison, GS Classification System, Single Factor, Limited Factor, and Competency based plans will be addressed. In addition, the factors  more...

Hybrid Quality Systems For Pharmaceuticals - Combining ICH Q7A Part 210-211 - Webinar By GlobalCompliancePanel The manufacture of drugs is controlled by ICH-Q7A and 21 CFR Part 210 & 211. Although these standards were written 24 years apart, they complement each other in many ways. Thursday, September 29, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePan This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful  more...

21 CFR PART 11 Complete Manual for Compliance Success - Webinar By GlobalCompliancePanel FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection.  more...

Excel Spreadsheet Validation to Eliminate 483 - Webinar By GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for yo  more...

Recent Major Industry CGMP Failures and How to Avoid Them U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/ 211, and 820). They are then required to translate those regulations into procedures and work instructions.  more...

Master Validation Planning - Webinar By GlobalCompliancePanel A Validation Master Plan (VMP) is a critical part of a successful validation project. It documents the intended path to be taken for the validation of an entire organization, one or multiple plants, a single system or assembly line, or even a collection of similar equipment, to be qualified and eventually validated.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...inar will address the use of FDA Guidance's, 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 acceptable cGMP Part 11 software validations. The FDA and other regulatory agencies have stated that software validation can  more...

Effective Hazard Analysis to meet FDA and ISO134852003 Risk Management Requirements - webinar by global compliance panel FDA-GMPs, known as Quality System Regulations (QSRs), and ISO 13485 require Risk Management as integral part of the development life cycle.  more...

Excel Spreadsheet Validation to Eliminate 483s by gcp This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.  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...

Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean ...he corresponding Theory of Lean Configuration to this key part of a QMS. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in controlled documents - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time  more...

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ... clearly, it didn't happen either. GMP compliance (21CFR, Part 211 and Eudralex, Volume 4) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and support areas. Good Documentation Practices describe the required activities and steps to use when recording data and other handwritten entries. Personnel, who work with documentation must be  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...to protect all kinds of PHI and taking regular actions as part of a security management process. Proposed changes and expansions to HIPAA, going into effect in 2011, dramatically expand the types of entities to which the regulations directly apply, which means that more entities than ever need to adopt the proper HIPAA Security policies and procedures to be in compliance. HHS compliance  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...his 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 acceptable software validations. The FDA and other regulatory agencies have stated that software validation can  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...roper up-front risk-based, closed-loop RCA as an integral part of CAPA, Validation and Quality Management Systems / cGMP planning, implementation and execution. Areas Covered In the Session: * Regulatory "Hot Buttons" * The 4 Basic Steps to Problem Solving * A Suggested Investigation Template * ID / Document the Problem * Investigation / Analysis Methodology - The  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...y FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered. Why Should You Attend: Verification and validation requirements have always been part of 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  more...

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel ...Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441 Risk Analysis is obsolete & upgraded to 14971 Medical Devices - Application of Risk Management to Medical Devices, all facets of risk management must be considered from cradle to grave. The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel ...Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries. Why Should You Attend: More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more and more  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...you manage your computer systems in compliance with 21CFR Part 11." These words from an FDA or state regulatory inspector can send shivers down your spine. Are you ready for an internal QA or FDA inspection at your site? Areas Covered in the Session: * 21CFR Part 11 Compliance * Review of the regulations * Regulatory requirements * Site Inventory * Compliance  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...ctive 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 and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...rt to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..." The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...nt regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site. Monitoring systems should include specific components to ensure control of investigational product, data  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...iques and sequence. * Discuss what role each garment part plays in contamination control and human safety. * Explore expectations of cleanroom garment suppliers. * Discuss cleanroom gowning tests and personnel qualification. Who Will Benefit: * Q Auditors and Personnel * Manufacturing Operators * Maintenance and Cleaning Personnel * Operations managers  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...y, it didna ™t happen either. GMP compliance (21CFR, Part 211) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and support areas. Good Documentation Practices describe the required activities and steps to use when recording data and other handwritten entries. Personnel who work with documentation must be informed of these  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ... and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this learning experience. Questions are strongly encouraged. Areas Covered in the Session: * Module 1 - Introduction to Quality and Compliance Concepts * Module 2 - Differences between Medical Devices  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel Overview: When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems. This web seminar will give a good understanding on the regulatory  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel ...eam to perform the evaluation, which will be an important part of this presentation. Why you should attend: One of the most important Risk Management activities is the Overall Residual Risk Evaluation which occurs at the end of the development cycle to assure the product risk meets the risk acceptability criteria prior to issuing the Risk Management Report and release of the product.  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...collection activities. While Risk Management Plans can be part of the Quality Plans for a product, important characteristics of the Risk Management Plan must be documented to meet requirements. In situations where development and manufacturing activities are located in different areas and are under different management structures, the Risk Management Plan must document the divided  more...

Excel Spreadsheets Step-By-Step Instructions for Compliance - Webinar By GlobalCompliancePanel ...ep-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs. Areas Covered in the Session: * Develop spreadsheet applications that are GxP compliant. * Avoid 483s and warning letters. Critical data, such as laboratory information and other GxP  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ...re identification and notification through documentation. Participants will review root cause analysis techniques and observe how to identify corrective and/ or preventive actions towards successful remediation and closeout. This high-level overview will provide clarification on the steps of an effective investigation, what documentation is required along the way, and how to establish a  more...

XML Training ...ree XML Syntax Comments in XML Special characters Parts of an XML document XML Prolog 6. XML FAMILY TREE What is XML Family tree? Tree rules XML Ancestor and XML Descendant XML Parent and XML Child XML Sibling 7. ELEMENTS & ATTRIBUTES What is an element? Naming rules for elements Root element What is an attribute? XML Elements vs. Attributes 8. XML  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...trial activities for a clinical trial will be supplied as part of the seminar, which will include the following: * Obtain a brief from the Project Sponsor which defines the clinical trial objectives, rationale, outline timeframe, and estimated budget available * Review literature and other available information * Discuss the therapeutic areas with experts in the company and  more...

Introduction to Investment Risk - Credit Market and Portfolio - Webinar by GlobalCompliancePanel ...andards in use today. Areas Covered in the Session: PART ONE - Market Risk After attending this session, you will be able to: * Differentiate between Qualitative and Quantitative Techniques * Apply Three Approaches to Value at Risk (VaR) * Understand the Limitations of VaR * Prepare for Black Swans PART TWO - Volatility, Risk Aversion, and Portfolio Management  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...CFR 820. 180 provides General Requirements for records. Part 11 has additional requirements when these are electronic records. We look at the requirements for electronic records and some of the issues these requirements raise. We also examine the current guidance document on electronic records and explain where FDA will exercise "regulatory discretion" and what that means. We discuss the  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...Part 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought. Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of these technical  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...Part 11 is FDA regulation for electronic signatures and electronic records. It started by the Pharma - it is a good regulation for medical and Pharma companies but it is also a good guideline for other industries. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...ttend: With the FDA announcing that it will be performing Part 11 audit this year and the FDA currently inspecting and issuing warning letters to companies that have violated PDMA requirements, it is important to understand what the requirements are and how to ensure compliance with them. Noncompliance can cost companies millions in fines. * Understanding the purpose of validation  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...bstances, and review of dispensed prescriptions. Class participants will familiarize themselves with federal laws and DEA regulations requirements for handling of Schedules II though V controlled substances in a pharmacy setting and the record-keeping and security responsibilities placed on the pharmacist. Areas Covered in the Session: * Discuss the types of federal criminal and  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...e power of current risk management tools, which must be a part of such an analysis. A growing push by the Agency to strengthen the 510(k) process in the U. S. and take a renewed look at "grandfathered" product by the Agency is one result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel Overview: 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  more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ... website, we find CAPA cited in most cases. CAPA has been part of FDA regulations on the medical device industry since the 1970's and companies should have developed good CAPA systems some years ago. But FDA continues to find problems with Corrective Action and Preventive Action in quality systems. This is a foundation of the quality system and should be a well-controlled process. FDA feels  more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel ... intent is the same for all regulations only FDA's 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still leave a lot of room for interpretations. Reference material for easy implementation: * SOP: Recording of GLP and GMP Raw Data. * SOP: Retention and Archiving of Electronic Records * Checklist: FDA Record Retention and Retrieval Areas  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...iolations 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 being reported and the timeliness. Some at FDA are concerned that manufacturers have not  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...uyers for risk reduction, food safety becomes an integral part of the overall operational strategy and everyone wins. Areas Covered In the Seminar: * Risk management represents a move from a reactive after-the-outbreak mode of operation to a preventive, cost saving, reputation saving strategy. * Risk of food safety outbreaks as they impact insurance costs * Where to find  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...ar will focus primarily on the principles embodied in CFR Parts 210-211 and ICH Q7A for pharmaceuticals and Part 820 for medical devices as well as pertinent passages of the International Conference on Harmonization (ICH) and the Global Harmonization Task Force (GHTF) guidances. The attendees will quickly learn and understand the quality systems principles through the many graphical visual  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ...ext 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 program is the long  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...oach that can best be taken for resolution. Agenda for Part I: Japan - Understanding the Dynamics of the Changing Structure, Regulatory Requirements and Compliance Processes for Life Science Products * Japan's Regulatory Structure for the Life Science Product Industries o Demographic Overview o Regulatory Framework: Key Agencies Involved / Reporting Structure  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...hen the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing misconduct on the part of the investigator is handled.  more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel ...ustry 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 past year will provide direction in areas of concern and what to expect in the future. A brief overview of their changing focus re: medical devices and  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ...ar: 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, and 40 subcategories of operational risk * What to look for in taking a holistic and systematic approach to op risk * Comprehend the major qualitative and quantitative tools used in op risk *  more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the  more...

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel ...uch as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for regulated environments. However, with a good knowledge of Excel capabilities combined with good procedures and practices on how to validate and use Excel  more...

Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - Webinar by GlobalCompl ...anufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software validation project time. Methods for decreasing resource requirements, and making documentation more manageable and understandable often result in a savings of two-thirds the costs. Additionally, this course will help companies  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...

21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to  more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel .... Auditing API producers and suppliers is an important part of GMP compliance programs. Identifying what approach or process to use is examined and the tools to utilize during an audit is also discussed. Audits at best are snapshots of what exists at the moment of the audit; however, a good audit or auditor will be able to uncover the less obvious signals and signs of concern. Learn what  more...

21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...rt to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..." The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue  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...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G ...aged" combination products. FDA proposes to create 21 CFR Part 4, subpart A, to codify the cGMP requirements that apply to combination products. What current good manufacturing practice requirements apply to my combination product? The proposed rule seeks to clarify which cGMP requirements apply when drugs, devices, and biological products are used to create combination products. The agency  more...

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel ...ation shows the application of statistical techniques. In particular, the guidance explains the use of design experiments (DOE) to establish process parameters and develop challenge points for the Operational Qualification (OQ) phase. The guidance explains the concepts of process capability showing the relationship between the process statistical characterization and the engineering  more...

Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking - Webinar by GlobalCompliancePanel Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical. Cell line development followed by preparation of the master/ working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection- Webinar by GlobalCompliancePanel 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.  more...

FDAs New Enforcement of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just from 2007 to 2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003  more...

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel ...ing clause. These changes also include suppliers who are part of the same parent organization, such as a separate department or division. To help clarify the requirements, ISO issued a guidance document on Outsourced Processes. The presentation explains the changes to ISO 9001, and recommendations in the guidance document. We take a practical implementation approach, showing how to  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part ...to soon conduct a series of inspections related to 21 CFR Part 11. FDA made it very clear that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and Part 11 compliance. Just from  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel How do you prevent becoming another FDA statistic? Poor corrective and preventive action (CA/ PA) and investigations continue to be among top FDA Form 483 deficiencies issued to drug, biologic, and medical device manufacturers. It's in everyone's self interest to improve the quality of investigations and CA/ PA. This webinar will provide regulated companies the core principles and practices needed  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement. The presentation states with the regulatory requirements in the FDAa ™s QSR, ISO 13485, and ISO 9001. After analysis of  more...

A Guide for Compliance with Document Control Requirements for Food Manufacturers - Webinar by GlobalCompliancePanel An essential part of the Food and Site Security Plan and the Bioterrorism Act. of 2002 section 306. The control of food safety and quality records as required by customers, regulators and internal audit and legal disciplines.  more...

ITIL Foundation Bridge Virtual Classroom ...naging IT services to deliver to business expectations as part of the new v3 release of ITIL. This Bridging Course is designed as an update for candidates who hold Foundation certificates from earlier versions of ITIL to a level of knowledge and understanding in line with the ITIL v3 Foundation Certificate in IT Service Management. This course positions the student to successfully complete the  more...

21 CFR Part 11 - Compliance for Electronic Records and Signatures GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 24, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase,  more...

21 CFR Part 11 Auditing for Part 11 Compliance GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 18, 2010. Webinar will be presented by Jasmin NUHIC. 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems ...Panel brings a new webinar on the topic of Internal 21CFR Part 11 Compliance Auditing of Computer Systems. Webinar will be on March 11, 2010. Webinar will be presented by Richard Poser. Mr. Poser is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device  more...

Excel Spreadsheet Validation To Eliminate 483s GlobalCompliancePanel brings a new webinar on the topic of Excel Spreadsheet Validation To Eliminate 483s. Webinar will be on March 10, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development,  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection ...mpliancePanel brings a new webinar on the topic of 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection. Webinar will be on March 4, 2010. Webinar will be presented by Jasmin NUHIC. Mr. NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms,  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...

Business Broker Training Webinar ...g can be done during the day or in the evening. THE BEST PART - after deposit - you can break your training fee into installments spread out over the year. NO installments until February 1, 2011. Your TWO Day 1-on-1 Online Training Program Overview... 1. Broker Prep 101 - Has you all set up and ready to broker BEFORE training so you can immediately launch after training 2. The  more...

Tax Lien Investing Webinar- Series II Tax liens are loaded with money-making potential that are rewarding and lucrative for investors with any level of experience. The best part is there are literally thousands of tax liens available at public sales nationwide and very few people know about them. However, it is important to be informed as there are some things to watch out for.  more...

Complete Java Training ...ining * All the open source softwares are provided as part of Training * A computer with internet connectivity. * Operating system that supports Java 1. 5. 0 or later * Eclipse 3. 2 * My SQL 5. 0 ================================================ Java EE Introduction training * Java EE Overview * Java EE Architecture * MVC Architecture * The Virtual Machine and  more...