Covered Web-based Seminars

Webinars Online, educational sessions, describing and demonstrating key techniques and approaches to the analysis of business process and systems. Topics covered will include (in different sessions): Business Process Modelling Notation (landscapes and workflows), Unified Modelling Language (primarily use case, activity and class mdoelling), Data Modelling (entity relationship and physical schema  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...

SharePoint Designer Training ...raining 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. In this SharePoint Designer course, students will learn the core features and functions of SharePoint  more...

Object-Oriented Analysis and Design (OOAD) Training with UML ...el of the business requirements. All the UML diagrams are covered in this OOAD class to identify the most suitable diagram suite for your organization. An emphasis is placed on Use Cases to capture and manage requirements and form the basis for test scenarios. Class relationships, through the use of Design Patterns, are leverage to enforce OO concepts that will produce a reusable structural  more...

MOC 8820 - Payroll - US in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Payroll training class provides an in-depth view of the extensive functionality contained within the Payroll application. Besides learning the functionality, this class also explains tips and techniques that can help make an implementation successful, and gain a more thorough understanding of the Payroll application and its capabilities.The Dynamics course covers the  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...

Introduction to Java Training This Java training course is intended for students without an extensive programming background. It covers most Java syntax elements, concentrating on fundamental and universally useful elements, while providing an overview of many more advanced elements. Students will learn to write useful Java classes, applying Object-Oriented concepts such as inheritance, and create Java programs that work  more...

Comprehensive JSP Training ...sing using scripts and or actions. Although scripting is covered, the scriptless authoring style encouraged by the JSP 2.0 specification is emphasized, and students will be well equipped to develop concise and effective JSP applications. The second module covers the JSTL, or JSP Standard Tag Library, actually a set of four custom tag libraries that establish a portable standard for common  more...

Java Swing Training ...ment are reviewed as necessary. The standard controls are covered, including labels, text components, buttons, listboxes, and comboboxes. Architectural patterns are emphasized, especially JFC ' s strict use of the Model-View-Controller paradigm. Understanding the thorough use of this pattern in JFC is critical to using the framework effectively. Event handling is treated, both handling  more...

Introduction to JavaServer Pages This two-day module introduces JavaServer Pages, or JSP, which is the standard means of authoring dynamic content for Web applications under the Java Enterprise platform. The module begins with an introduction of Web applications in general, shows how Java servlets and JSPs establish a framework for writing Web applications, and then covers JSP 2.0 features in detail, from scripting elements to  more...

Introduction to Crystal Reports 2008 Training This Crystal Reports training class is designed for new users of Crystal Reports 2008. Some of the topics covered include a review of the software features, report design and the creation of presentation quality reports. Students get practical experience through plenty of hands-on exercises.  more...

Budgeting Training: Budgeting Basics ...nd manage budgets. Virtually every aspect of budgeting 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  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ...es into how they do business in their facilities. Areas Covered In the Session: The new regulations will be reviewed and their effects on usual practices will be discussed, as well as what policies need to be changed and how. We will show what policies and evidence you need to produce if you are audited by the HHS Office of Civil Rights. Now that there is a legislative mandate to audit  more...

Risk Management in IEC 60601-1 Third Edition - Webinar By GlobalCompliancePanel ...erstanding the requirements of the new standard. Areas Covered in the Session: ISO 14971 compliance is a requirement of IEC 60601-1 The new standard uses risk management throughout The new standard is less prescriptive in many areas The new standard requires that all applicable collateral and particular standards must be used for compliance Current activities leading to full  more...

Clean Room Microbial Load and Characterization of Microorganisms in the Clean Room Environment - Webinar By GlobalCompliancePane ...covered, and a review of types of microorganisms that can be present, will be discussed. A general review of environmental niches where they may be present will be discussed. You will be introduced to the different methods available to conduct testing. Key areas discussed will be Compressed Air, Personnel Monitoring, Surface and Raw Material Monitoring. Recommended selection of sampling  more...

Calculating Overtime Correctly - Webinar By TrainHR ...cki 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 pay How to handle overtime calculations once you've determined that a bonus qualifies as includable  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...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel ... of the specific contaminants for your products. Areas Covered in 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  more...

SAP FICO Online Competency Development Training program ... each module, a Notes and study material for examples covered. a Access to the Training Blog Training Format: This course is delivered Online using Web and Audio Conferencing. Timing: Weekdays and Weekends after work hours. ABOUT THE TRAINER: a More than 8 years of Consulting & Teaching experience in different modules of SAP FICO. Primarily SAP FI & CO. a With a strong  more...

JAVA J2EE JEE Professional Role Based Training from Zaran Tech ... each module, a Notes and study material for examples covered. Training Format: This course is delivered as a highly interactive session, with extensive live examples. This course is delivered in Online using Web and Audio Conferencing. Timing: Weekdays and Weekends after work hours. ABOUT THE TRAINER: 1. Worked in various domains like Insurance, Financial / Banking, Retail, Auto,  more...

SAP BOBJ with BW integration Online Competency Development Training program ... each module, a Notes and study material for examples covered. Training Format: This course is delivered as a highly interactive session, with extensive live examples. This course is delivered in Online using Web and Audio Conferencing. Timing: Weekdays and Weekends after work hours. ABOUT THE TRAINER: a More than 12 years of Consulting & Teaching experience in different modules  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...3;s resource constrained industrial environment. Areas Covered in the Session: Verification or Validation Current Regulatory Expectations and Recent Audit "Hot Buttons" The Part 11 Project Validation Plan The Simplified Approach to 21 CFR Part 11 Compliance and Software V&V When and How to Use DQ, IQ, OQ, PQ (or their equivalents) Simplified Sample V&V Test Cases and their Development  more...

Practical Laboratory Statistics This presentation will attempt to remove the fear of statistics that most people share. We will not spend much time on complex equations. Rather, we will focus on the concepts of statistics, and how you can use these concepts to interpret your laboratory results. Our focus will be on using basic spreadsheet functions to compare data sets generated from many different kinds of test equipment.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...e incorporated into the design inputs correctly. Areas Covered in the Session: Introduction Terminology / Definitions Radiation characterization / effectiveness Process Equipment Product and Material Issues Process Definition Validation IQ/ OQ/ PQ Documentation, review and approval of validation Routine Monitoring Product Release Maintenance of process effectiveness Who Will  more...

Breakthrough Performance Management that is Practical Effective and User-Friendly ...erformance variables that might be important, but are not covered on the appraisal instrument. Ratings are useful for documentation, but do not help with performance improvement. Areas Covered in the Session: Performance Management How to Give Feedback Coaching Counseling How to handle personnel problems How to improve performance of subpar employees How  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a ...sts organizations millions of dollars each year, Areas Covered In the Seminar: How the ADA, FMLA and Workers' Comp intersect When do conduct problems become mental illness? What do you say to a depressed employee? What protection do alcoholics and substance abusers have under the A. D. A. How to handle threats and other disruptive behavior The 5 biggest mistakes managers make in  more...

Document Retention and Destruction ... full and accurate compliance. Some documents also may be covered under more than one law or regulation, so you should adhere to the more stringent requirement. If there is any area which contains documents under litigation, it is best to retain all records involved until the case is resolved and always refer to your company attorney for guidance. For your protection and convenience  more...

Preventing Harassment in the Workplace by TrainHR ...nd 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 it should be communicated, and who is held responsible for assuring compliance. Also included is handling complaints, documenting charges and conduct and addressing any situation that may be  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...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...PAA audit and enforcement processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10, 000. We will discuss what information and documentation needs to be prepared in advance so that  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...gators actually look for during a lab inspection Areas Covered in the Session: 21CFR and Eudralex references to documentation Correcting errors and omissions Dates and formats Meanings of initials and signatures Use of "NA" Comments and explanations Handling raw data (charts, strips, printouts) Blanks Entering numerical data OOS  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...r 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 NB Audit Focus  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...ers, cell phones, and portable data devices. All entities covered under HIPAA must take special care of electronic patient health information, including establishing policies and procedures 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  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...cted changes. Attendees will learn what information is covered under the HIPAA and PCI rules and what are the ways the information should be protected, including the safeguards called for by HIPAA and PCI. They will learn what are the consequences of not protecting health and payment information and what to do if their information security is compromised. We'll talk about strategies to limit  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ...entified to ensure that the most significant risks are discovered and adequately prioritized. The risk analysis process will be applied to a simplified example in order to relate the process to a real situation and drive home the usefulness of the process. Areas Covered in the Session: * Learn how to conduct an information security risk analysis suitable to aid in compliance with  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...f the "Principles of GCP" and a definition that is clear. Covered also will be what the practices are that ensure subject safety and credible data, which are the hallmarks of GCP. You will see why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...ble manner to treat, cure, and diagnose disease. Areas Covered in the Session: * Defining IQ/ OQ and validation and its role in maintaining product quality * Roles and responsibilities in the validation process * The process validation lifecycle from design to product discontinuation * How about Process Analytical Technology (PAT) * Similarities and  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ...ish with a CMO is critical to your supply chain. Areas Covered in the Session: * Examine key elements of an API audit * Audit preparation * The audit itself o Opening Session o Audit itself o What to look for? o Discussion of findings o Suggestions and experience * Closing Meeting * Who should participate in  more...

Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel Overview: CAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM. The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical,  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...3;s resource constrained industrial environment. Areas Covered In the Session: * Verification or Validation * Current Regulatory Expectations and Recent Audit "Hot Buttons" * The Project Validation Plan * Product and Process / / Facilities / Equipment Software V&V * When and How to Use DQ, IQ, OQ, PQ (or their equivalents) * GAMP / Other Considerations *  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...s / 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 7 RCA "Tools" * Find the Solution(s) * Monitor for Effectiveness * Lock In the Change - Close the  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ... but proper up-front V&V planning and execution. Areas Covered In the Session: * Verification or Validation - Recent regulatory expectations * The Master Validation Plan / structure * Product Validation a how it differs from process / equipment V&V * Process / Equipment / Facility Validation - FDA's new guidance * When and How to use DQ, IQ, OQ, PQ, or their  more...

Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel ...nes, newspapers available to firms' competitors. Areas Covered in the Session: * Complaint definitions - FDA, Canada & Europe * FDA's complaint handling requirements * Canada & European Union complaint handling * FDA's voluntary & mandatory reporting * 21CFR 803, 806 & 810 explained * FDA regulatory actions against firms * Adverse event reporting - Canada  more...

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel ...rers and has been replaced by "Risk Management". Areas Covered in the Session: * Failure Mode Analysis Terms * Risk Management and FDA * Risk Management in Design Control * Risk Management & ISO 14971 * Risk Management in Design Control * Risk Management & ISO 14971 * Risk Management & Medical Device Directives Who Will Benefit: * Regulatory  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel ...zation 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 inspection; * Detailed description of HOW TO handle the FDA inspection during the inspection itself; * Some trends  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...r 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 Assessment * Risk Assessment Who Will Benefit: The employees who will benefit include: * End-users responsible for applications that need to be validated *  more...

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel ...ng procedure is, and what a Work Instruction is. Areas Covered In the Session: * How to write a work instruction * How to write a standard operating procedure * Properties of an effective work instruction * Properties of an effective Standard operating procedure * The differences between work instructions and Standard operating procedures. Who will benefit:  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...nd testing data and maintaining them in the DHR? Areas Covered in the Session: * FDA Quality Systems Regulation Requirements/ Definitions * MDD Requirements/ Definitions * Design History File (DHF) o Definition o Typical contents o DHF and outsourced design/ production o DHF and OEM relationships * Device Master Record (DMR)  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...actices 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 far and in-depth do you go with your investigations * What are current FDA "hot" buttons and trends * Benchmarks and best practices for  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...lity to improve the level of validation success. Areas Covered In the Seminar: * Outline of FDA regulations as applied to software. * Review of FDA software validation requirements. * Why validation makes good business sense. * Most Common Problems in FDA Software Validation & Verification. * Strategies on how to avoid the most common problems. * Advice on  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel ...earn how to better audit quality record systems. Areas Covered in the Session: * Introduction * Guidance documents/ QS regulation * Major FDA 483 points * Trends in FDA warning letters * Determining best practice for the DHR audit * Be prepared by knowing how to conduct a MORE thorough record audit * FDA 483 point issuance prevention Who Will Benefit:  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel ...analysis and meet HITECH and HIPAA requirements. Areas Covered in the Session: * "Meaningful Use" data security analysis requirements * HIPAA risk analysis requirements * Methods for building a customized analytical tool * Questionnaires and forms Who Will Benefit: * Healthcare providers * Healthcare privacy officers * Healthcare security officers  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...need to maintain a validated cloud based system. Areas Covered in the Session: * The difference between the Conventional Implementation and a Saas Implementation Methodology * When requirements can be limited to Customer specific configurations * When the Customer specific configuration can be validated rather than the full system. * When Vendor SOPs can be leveraged in  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...heard about? * Can you improve the process? Areas Covered in the Session: * Sampling concepts o With or without replacement o Simple or stratified sampling * The binomial distribution o Possible outcomes and Bernoulli trials o The binomial formula and what it means o The cumulative binomial * Sampling plans  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...g to provide a better product for your patients. Areas Covered in the Session: * Regulatory Expectation (FDA and EU) * Creation and Revision of Master Production Record (MPR) * Review and Approval of MPR * Content of the MPR * Issuance of BPR * Device Master Record (DMR) * Roles and Responsibilities Who Will Benefit: * Manufacturing (production  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...quirements and Automated Testing considerations. Areas Covered in the Session: * System Based Test Tools vs. Paper Based Test Tools * Paper Based Validation Practices vs. System Based Test Tools * Test Management Tool Implementation Considerations * Test Management Tool Usage Considerations * Automated Testing Considerations Who Will Benefit: * IT  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...the Sponsor's / CRO's Monitors are so important. Areas Covered in the Session: * What doe the FDA look at when Auditing/ Inspecting a study? * The Sponsor's responsibility in monitoring study conduct * Components of a sponsor monitoring system beyond SOPs * The nature of adequate oversight of all staff and non-staff * The importance of Protocol knowledge in  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...stablish a consistent manufacturing environment. Areas Covered in the Session: * Identify what garment systems are available. * Identify and discuss good and bad cleanroom gowning. * Identify gowning techniques and sequence. * Discuss what role each garment part plays in contamination control and human safety. * Explore expectations of cleanroom garment suppliers.  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...rocesses and ensure best practices are followed. Areas Covered in the Session: * Learn about cleaning and what it accomplishes in the cleanroom. * Identify cleaning agents, tools, and equipment. * Discuss cleaning personnel training and qualification. * Identify the methods of cleanroom cleaning. * Identify and discuss extent and frequency of cleanroom cleaning.  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...cating Analytical Instruments to USP Categories Areas Covered in the Session: * Operational lab equipment requirements for calibration and qualification * Most common inspection problems * USP Chapter : Analytical Instrument Qualification * Development of an effective equipment qualification master plan * Calibration/ qualification phases: design qualification,  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel ...forts toward the real value of the FMEA process. Areas Covered in the Session: * What is an FMEA o What are the components of an FMEA? * How should I use FMEA in performing risk management? * What are the problems with FMEA in risk management? * How is an FMEA conducted o What and who are needed o Identifying significant risks  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...ysis of ISO 13485 with comparisons to ISAO 9001. Areas Covered in the Session: * Principles of ISO 13485: 2003 * ISO 9001 & ISO 13485 Differences * Risk Management & ISO 14971 * FDA's MDR's & EU Vigilance * Design Control * MDD 93/ 42/ EEC & Essential Requirements Who Will Benefit: * Manufacturing & Design Engineers * Marketing Product Managers  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...iew rounding and limit expression determinations Areas Covered in the Session: * 21CFR Part 211 and Eudralex references to documentation * Correcting errors and omissions * Dates and formats * Meanings of initials and signatures * Use of "NA" * Comments and explanations * Handling raw data (charts, strips, printouts) * Blanks * Entering  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel Overview: This webinar will discuss the evolution of the standards, describe a Pharmaceutical Quality System and discuss the transition to the Pharmaceutical Quality System. Why you should attend: The US FDA, and regulatory agencies around the world, are actively promoting the concept of a Pharmaceutical Quality System. The concept of a Quality System was imposed on the medical device industry  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...g experience. Questions are strongly encouraged. Areas Covered in the Session: * Module 1 - Introduction to Quality and Compliance Concepts * Module 2 - Differences between Medical Devices and Pharmaceuticals * Module 3 - Scope of the GMPs and the Quality Cycle * Module 4 - Standards of Quality * Module 5 - The Shifting Paradigm to Focus on Customer and User  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...ing GMP audits at your manufacturing facilities. Areas Covered in the Session: * Review current regulatory status of rapid method acceptance * Regulatory publications and presentations focusing on RMM implementation * Current perspectives from the U. S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Australian Therapeutic Gods Administration (TGA) and  more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...ompliance with sound quality management systems. Areas Covered in the Session: * Compilation of Completed Records * Quality Technical Agreements * QA review of production records * Laboratory Testing Results * Batch Production Record Review * Critical Utilities and Environmental Monitoring Data * Requirements for COA * Communication * Lot  more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel ... Objectives of the Presentation: The following areas are covered: * DEA Office of Diversion Control: This section will familiarize you with the authority given to DEA Diversion Group when enforcing the laws and regulations pertaining to controlled substances and regulated chemicals. * Controlled Substances Act: Briefly describes the criminal and civil actions that can be imposed on  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ...st: Retrospective Validation of Computer Systems Areas Covered in the Session: * Definition of legacy systems and retrospective validation * FDA requirements and inspection practices * Examples of FDA warning letters * Industry recommendations, e. g., from the GAMP * Assessment activities, e. g., gap analysis and risk assessment * Reviewing and updating the  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ...ory penalties for willful neglect of compliance. Areas Covered In the Seminar: * Learn about the new requirements for HIPAA Business Associates * Find out what has changed for Business Associates * Learn how the definition of BA has been significantly expanded * Learn what goes into a proper Business Associate Agreement * Find out about the new, higher enforcement  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ... went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it  more...

Off-Label Promotion of Medical Devices Maximizing Your Performance Claims within FDAs Framework of Acceptable Practices - Webina Overview: The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations from the FDA. You will improve your understanding of regulatory expectations for your products and improve promotional compliance for released products. The webinar is designed to  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel Overview: The webinar examines critical parts of design control after product release including: design change control, design validation, and the Design History File. The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your  more...

Regulatory Complaint Handling Vigilance Recalls - Webinar By GlobalCompliancePanel Overview: Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result. This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included.  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel ...how to perform Overall Residual Risk Evaluation. Areas Covered in the Session: * Choosing the Evaluation Team * Determining the Evaluation Process * What documents should be part of the review? * Using the Risk Chart in the review * How to compare to the Risk Acceptability Criteria * Documenting the results of the Evaluation Who will benefit: * Risk  more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel ...process as well as additional time requirements. Areas Covered in the Session: * Requirements of IEC 60601-1 Third Edition * Required use of Collateral standards * Required use of Particular standards * Required use of ISO 14971 Risk Management * Use of IECEE Test Report Forms Who will benefit: * Compliance Engineers * Project Managers * Quality  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ... required to be in compliance with the standard. Areas Covered in the Session: * ISO 14971 requirements for risk management planning * Setting Risk Acceptability Criteria * Planning for verification of risk control implementation and effectiveness * Documenting responsibilities for risk activities * Establishing risk review activities * Example of a risk  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...manded by FDA with the release of this standard. Areas Covered in the Session: * Specific discussions include * Background of the original guidance, its history, application, and items covered * FDA regulatory authority * Growth of competing standards and the competing expectations of the medical device industry * The history and philosophy of the new guidance  more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel ...Chapter 5. 1.6 and the PDA Technical Report #33. Areas Covered in the Session: * Learn how to develop a validation strategy * User requirements specifications (URS) * Design Qualification (DQ) * Supplier assessment/ audit * Functional design Specifications (FDS) * Requirements Traceability Matrix (RTM) * Developing test plan, including installation,  more...

Excel Spreadsheets Step-By-Step Instructions for Compliance - Webinar By GlobalCompliancePanel ... 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 data, is often recorded in spreadsheet applications and are subject to regulatory inspection. * Learn how to use Excela ™s built in 21 CFR  more...

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel ...ill prepare you to perform a validation project. Areas Covered in the Session: * Learn which documents the FDA expects to audit. * How to use the risk-based validation approach to lower costs. * How to link requirements, specifications, risk management, and testing. * Document a computer system validation project using easy to understand fill-in-the-blank templates.  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ...tive root cause analysis for corrective actions. Areas Covered in the Session: * Elements of a thorough investigation process (Discovery through Closeout) * Identifying the Problem * Introduction to Root Cause Analysis * Define corrective action and preventive action * Effective Documentation of the Investigation Process * Skills and Tools of an Effective  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ...t CRO or research site to conduct their studies. Areas Covered in the Session: * How to set up and track your recruiting of subjects * The challenges of successful recruiting * The importance of your recruiting staff in the overall success of the unit or site * How to build a data-base of patients * How to recruit more efficiently for a target study * Factors  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel ...sentation will help to eliminate these problems. Areas Covered in the Session: * Calibration Basics * Types of Calibration - External standard, Internal standard, etc. * Calibration Options - Response factor methods, Linear regression * Evaluation of Data - Three tools for evaluating regression data * Discussion using real-world data sets Who Will Benefit:  more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel ...view: Food, Drug, and Cosmetic Act history basics will be covered as will implementing FDA regulations relevant to the Food, Dietary Supplement and OTC Drug industries that have followed. Some more recent major new regulations such as the Dietary Supplement Health & Education Act (DSHEA), the Bioterrorism Act, and the Food Safety Modernization Act will also be covered. Areas Covered In  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...his deficiency extends to other systems as well. Areas Covered In the Seminar: * History of design control * Design planning * Design input/ output * Design reviews * Design documentation * Design transfer * In-process design control Who will benefit: This webinar will provide valuable assistance to all companies that perform design activities. The  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...occur which may impact safety and effectiveness. Areas Covered In the Seminar: * What is Validation? * When should it be used? * How does it differ from verification? * Validation vs. Verification: Which One? * Protocol preparation * Different types of validation * IQ, OQ, and PQ Who will benefit: This webinar is targeted toward professionals involved  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ...s this way, you'll be well prepared for the FDA. Areas Covered In the Seminar: * History of FDA inspection methodologies, from haphazard to QSIT. * Anticipate and prepare for FDA inspection. * Identify what inspectors look for during a QSIT inspection. * In depth analysis of the 4 major subsystems. * Review of remaining subsystems. * Knowing how to utilize the  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ... have a great supplier control program in place. Areas Covered In the Seminar: * How to qualify new suppliers in a cost efficient manner * How to assess current suppliers in a cost efficient manner * How to perform supplier-related corrective action * Minimum documentation requirements for supplier qualification, assessment, and related corrective action Who will  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ...ent the organization in the best light possible. Areas Covered In the Seminar: * Pre-Approval Inspections * Overview of the pre-approval inspection process * Preparation in the months preceding the inspection * Preparation on the day of the inspection * What to expect on inspection day * Responding to 483 Who will benefit: This course is intended to provide  more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel ...e practical difficulties in complying with them. Areas Covered In the Seminar: * FDA requirements for handling OOS/ OOT results * Phase I- Laboratory Phase of Investigations * Phase II a Full Scale Investigation * Concluding an Investigation * Out-of Trend investigations * Common pitfalls during OOS Investigations * Review of recent OOS related  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel ...also an expectation in GLP and GMP laboratories. Areas Covered In the Seminar: * FDA requirement for Equipment systems * Overview of GMP/ GLP requirements for equipment * IIQ/ OQ/ PQ of Equipment * Equipment database * Equipment SOPs * Equipment Calibration and maintenance * Review of equipment related citations in recent Warning Letters Who will  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ... 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 changes to Implement the provision of Bioterrorism Act applicable to imported devices * Other proposed Amendments that would change  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...ial risk to public health: Class I, II, and III. Areas Covered In the Seminar: * Create and use a recall operational procedure and what should it contain * Understand what are effectiveness checks * What happens in a medical device recall and your responsibility * Learn why a recall is either a correction or a removal depending on where the action takes place *  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...s to help companies prevent off-label promotion. Areas Covered In the Seminar: * Off-Label Use of Drugs * Overview of Current Legislation and Regulations * Recent Legal Actions * Pros and Cons to Permitting Off-Label Dissemination of Information * Recent FDA Guidance - Good Reprint Practices * Leveraging Requirements for Validation Who will benefit:  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...is the study going to use electric data capture. Areas Covered in the Session: * What is a Project and why is it important for running clinical trials? o Defining the key characteristics of project management and the importance to clinical trials o Using an project management process for improving the success of your own clinical trials * Setting clear  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ... supplier buy-in. Coping with "rogue" suppliers. Areas Covered in the Session: * Regulatory "Hot Buttons" * Classify suppliers; Supplier requirements by "classification" * What's behind the COA? The COC? * The FDA's increasing emphasis on the site audit * Types of remote audits * Maintaining the relationship Who Will Benefit: * Senior management in  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ..., and how to maintain it as a "living document". Areas Covered in the Session: * The Revised ISO 14971: 2007 for Devices * ICH Q9 for Pharma * Product Hazard Analysis * Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis * Fault Tree Analysis * Suggested Risk Management File / Report, FMECA, FTA Templates * The Team and Its  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...tting senior management buy-in. Supplier buy-in. Areas Covered in the Session: * Change Control a what it is; what it is not * Areas impacted by Change Control * Regulatory / FDA 483 a Hot Buttonsa * Design Control * Document Control * Identifying changes * Preventing negative changes * Maintain a 'state of control' * Business needs and  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...ress areas of known deficiencies for FDA review. Areas Covered in the Session: * Key cGMP issues * Avoid complacency from past "good" FDA/ ISO audits * The desired response * How to respond now -- where to shift focus first * Where to direct scarce resources; A risk-based phased approach * How to address known problem areas during an Audit * Prove 'in  more...

Introduction to Investment Risk - Credit Market and Portfolio - Webinar by GlobalCompliancePanel ...the major frameworks and standards 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,  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...egulatory problems that are will be hard to fix. Areas Covered in the Session: * Overview of the regulations o Automated processes o Production and process changes o General record keeping requirements o Electronic records * Excel Validation o Setting the validation criteria + Data types +  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ... of the specific contaminants for your products. Areas Covered In the Seminar: * 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  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...nterpret, and act on the results of the testing. Areas Covered In the Seminar: * Define cleanroom filters and equipment * Identify regulatory expectations and industry standards * Define the tests, frequencies, and methods * Define the expectations for testing equipment * Identify who does the testing * Identify requirements for documentation/ logs/ labeling  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...ctical examples of process validation protocols. Areas Covered in the Session: * Recent Guidance Documents * Industry Practices * Examples of Process Validation Protocols * What should be included in Process Validation Protocols * The Importance of Good Process Validation * Common mistakes in Process Validation Who Will Benefit: * Director of Quality  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...ements of 21 CFR Part and how to implement them. Areas Covered in the Session: * Leveraging a Part 11 Interpretation document * The Importance of Part 11 in Requirements and Specifications documents * The Role of Risk Assessment in Part 11 Compliance * Technical Controls for Electronic Records * The Many Flavors of Audit Trails * Open vs. Closed Systems *  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel ...t of, and what these changes mean for companies. Areas Covered in the Session: * GAAP vs. IFRS * What will change * What will not change * Who needs to comply * The four key principles of IFRS * How disclosure requirements will change * The new rules for assigning values to assets * The deadlines for adoption * How IFRS will affect SOX  more...

Practical Laboratory Statistics - Webinar by GlobalCompliancePanel Overview: This presentation will attempt to remove the fear of statistics that most people share. We will not spend much time on complex equations. Rather, we will focus on the concepts of statistics, and how you can use these concepts to interpret your laboratory results. Our focus will be on using basic spreadsheet functions to compare data sets generated from many different kinds of test  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...can be immediately applied in your organization. Areas Covered in the Seminar: * Module 1 o Introduction and Overview o Correction vs. Corrective Action + Understanding of all elements of CAPA process step as required by ISO and regulatory agencies + Introduction to CAPA elements in a practical and proven manner which can be  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ... friends and/ or worst enemies at the same time. Areas Covered in the Seminar: * Module 1 - Overview and Understanding of the Regulation o Introduction and development of the regulation o What to expect in the future when it comes to the regulation o Options for (non)compliance o 'What ifs' o Most impactful sections and  more...

Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel Overview: Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical  more...

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel ...ternational standard for Food Safety Management. Areas Covered in the Session: The following areas will be addressed: * Key terms and definitions * General Requirements * Documentation * Management Responsibility * Resource Management * Planning and Realization of Safe Products a flow diagrams, process steps and control measures * Hazard Assessment -  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...urity responsibilities placed on the pharmacist. Areas Covered in the Session: * Discuss the types of federal criminal and civil actions that can be imposed on a pharmacy pertaining to the purchase, sale, transfer, dispensing, destruction and theft or loss of Schedules II through V controlled substances. * Identify the responsibilities of DEA through their Diversion personnel to  more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel ...nt product development phases will be discussed. Areas Covered in the Session: * Hazard analysis techniques * FMECA techniques * Probabilistic approaches * When to use which method during the design process * Effective evaluation strategies and documentation formats Who Will Benefit: * Project Managers * Regulatory Affairs * System Engineers  more...

Labeling Requirements for Dietary Supplements - Webinar By GlobalCompliancePanel Overview: This webinar points out current labeling issues including misbranding that are eating into profitability of dietary companies. The webinar teaches the attendee how to avoid common labeling compliance issues including: * Misbranding * Misleading claims * Misleading statements * Directions of use The webinar focuses on general labeling provisions for dietary  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...ethods with documented and defensible rationale. Areas Covered in the Session: * FDA Device Clearance / Changes in Direction * Product Changes and Filing a New 510(k) Responsibilities * Tracking / Evaluating Changes and the "Tipping Point" * "Risk-Based" * FDA's K97-1 and "Decision Tree" Model / Matrix * Resolving a "Wrong" Decision Who Will Benefit:  more...

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

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ... FDA. Use them to prove "progress against plan". Areas Covered in the Session: * Why formal Project Management * The three most common tools * How to compile * Gantt, CPM, PERT * Simple construction techniques * Work breakdown Structure, Milestones, Tasks * Effectiveness - Determining and Monitoring * The "New Product Example" * The "Remediation  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...ibutes to performance, it must be done properly. Areas Covered in the Session: * Review of GMP regulatory expectations of training (FDA and EU) * Recent training-related citations * High-Level description of a training system, including elements (needs analysis through evaluation), basic training documentation, management, GMP training plans/ planning, and trainers Who  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ...tively operate a social media marketing program. Areas Covered in the Session: * Legal issues from the public's perspective * Legal issues from the organization's perspective * HIPAA issues impacting social media marketing * "Spam" issues * Advertising rules * Content ownership and control * Potential SEC issues relative to social media marketing *  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel Overview: Preparation and organization are the keys to a successful audit. This session will allow your team to anticipate the auditors needs and result in the facility's ability to achieve the maximum benefit and score from the audit. Why you should attend: More and more customers are requiring GFSI audits such as ISO 22000, BRC and SQF or accepting them in lieu of their own audits.  more...

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

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ...ment subsystems to be reviewed by investigators. Areas Covered in the Session: * Review CAPA citations in FDA-483 and Warning Letters * Identify common problems with CAPA * Identify FDA CAPA regulatory requirements * Identify ISO 13485 CAPA requirements * Explore FDA's risk expectations of CAPA systems * Establishing a risk-based CAPA system Who Will  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...grated with the CAPA and Change Control Systems. Areas Covered in the Session: * What should be investigated - Complaints, audit observations, deviations, discrepancies, calibration out-of-tolerances * FDA expectations for investigations * The investigation-problem resolution process - understand the problem, identify possible causes, data collection, data analysis, root  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ... requirements and how you can ensure compliance. Areas Covered In the Seminar: * Guidances and regulations that govern the FDA's acceptance of foreign trial data as pivotal data for NDA approval * What you can do to ensure compliance * Design considerations and requirements for foreign trials * Identify which guidances and regulations govern the FDA's acceptance of  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...ed in amendments going into effect in 2011, calls for all Covered Entities and Business Associates, and their subcontractors, to be in compliance with provisions protecting all kinds of electronic protected health information. While many entities have gone through the processes necessary for HIPAA Security Rule compliance, many are only partially in compliance and have not performed all the  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ...ly cannot afford to miss this important webinar! Areas Covered in the Session: * Why water myths develop o Impact of c-GMPs o Well-meaning but misguided precedents o Scientifically unchallenged traditions and benchmarking o Rule-hungry culture * Water System Microbial Control Myths o WFI from RO o Turbulent Flow  more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel ... * Checklist: FDA Record Retention and Retrieval Areas Covered in the Session: * FDA Requirements for raw data and meta data * FDA Inspection and enforcement practices * Recommendations from industry task forces: GAMP/ ISPE guides * Definition of raw data: original records vs. standard electronic formats, paper print-outs * Ensure and demonstrate integrity of raw  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...g Letters to manufacturers for these violations. Areas Covered in the Session: * Review the FDA's Medical Device Reporting requirements. * Review FDA 483 MDR Reporting issues * Review Warning Letter Medical Device Reporting citations * Establish common problems in MDR reporting * What should MDR procedure contain? * What actions should be taken by complaint  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel Overview: While not captured in most audit reports, one of the biggest mistakes an organization can make is to have insufficient self audits. Internal audits are a core component of the Quality Assurance and Food Safety program. Ensuring the team representatives are trained and calibrated is a critical aspect of the program. An untrained team will miss important audit items, compromising the  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...ems that may lead to significant setbacks. The procedures covered are mathematically sound, simple to implement and can be implemented as a result of attention from any level in the operation. Generally, personnel in any operation can be employed in the risk reduction planning and implementation efforts. The session will also provide information regarding how to reduce supplier risk levels.  more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ...ponsors, and Institutional Review Boards (IRBs). Areas Covered In the Seminar: * Discuss how QA differs from QC and who is responsible for each * Determine who gets audited and factors and metrics for assessing when or why to audit * Discuss guidelines on how the FDA trains its investigators to audit Clinical Investigators (Sites), Sponsors, and Institutional Review Boards  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ... internal QA and external regulatory inspectors? Areas Covered in the Session: * Regulatory requirements for analytical instrument qualification * Calibration and Metrology Programs * USP * ICH Q2 * GXP * Equipment and Instruments - similarities and differences Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...nd testing data and maintaining them in the DHR? Areas Covered in the Session: * FDA Quality Systems Regulation Requirements/ Definitions * MDD Requirements/ Definitions * Design History File (DHF) o Definition o Typical contents o DHF and outsourced design/ production o DHF and OEM relationships * Device Master Record (DMR)  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...009. New requirements for business associates of HIPAA covered entities and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restricting and accounting of disclosures and increased enforcement activity. All kinds of covered entities, and now, business associates of covered entities and their  more...

Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel ... a better Excel user, saving you time and costs. Areas Covered in the Session: * Become compliance when using Excel spreadsheets for GxP data. * Reduce validation time and costs. * Increase compliance while lowering resource needs. * Avoid 483s and Warning Letters. * Understand what validation documentation is required. * How to use Excel's audit trail. *  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ...Part 11 * Validation templates and examples Areas Covered In the Seminar: * FDA inspections: Preparation, conducts, follow up * Learning from past Part 11 inspections * Scope of the new Part 11 program: time frame, expected outcome * Criteria for selection of target companies * What inspectors are looking for * How to prepare your company for the upcoming  more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel ...roubleshoot the process for better optimization. Areas Covered in the Session: * Understand the basic water system sanitization concepts * Use this understanding to design effective microbial control measures for your water systems * Use this understanding to solve microbial problems originating from poor sanitization practices * Debunk a few water system myths related  more...

Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel Overview: A how to guide to meeting customer expectations of the maintenance function. An overview of industry best practices and a review of some leading software solutions. Why you should attend: Maintenance is often found to present the greatest area of opportunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ... have different tracking methods and procedures. Areas Covered In the Session: * Review the key provisions in the updated FDA guidance on medical device tracking * Understand the regulatory expectations for device tracking * Identify new terms and criteria * Understand the statutory criteria and what changed * FDA has issued orders to manufacturers who are required  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...owed (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. It will be important to  more...

Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel ...s is a paradox for most auditors who when a problem is discovered increase their sample size. Most auditing sampling plans are based on either the binomial or normal distribution, though rare events usually follow the Poisson distribution. This talk will show how the Poisson relates to the binomial and normal distributions. Special attention will be given to risk management strategies. A  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel ...sult in the company's inability to ship product. Areas Covered in the Session: * Regulatory definitions of recalls, removals, and market corrections * Instances which require recalls, removals, or market corrections * What to do during recalls, removals, and market corrections * Recordkeeping requirements for recalls, removals, and market corrections * ISO  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel ...event similar observation on other laboratories. Areas Covered in the Session: * Regulations * Inspectional Guidances * Laboratory controls * Specification, standards, sampling plans, test procedures * Conformance to specifications * Complete data * OOS * Following procedures Who will benefit: The following individuals and disciplines will benefit  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...iew of 101 must-have's for corporate compliance. Areas Covered in the Session: * Mandated Areas for Annual Reviews * The Master Validation Plan -- Corporate and Site(s) * Training Issues * CAPA * Trending * Facilities; Production and Process Controls * Suppliers, Contract Employees, Consultants * Some basic OSHA Concerns; ties to the cGMPs *  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global ...strike a balance between compliance and quality. Areas Covered In the Session: * What are the objectives of ICH-Q10 and the FDA's Quality Systems Approach to Pharmaceutical Good Manufacturing Practices? * What are the similarities and differences between these guidance documents? * What are some Pro and Cons of the product lifecycle for pharmaceuticals * Is the Quality  more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel ...mportance to OTC Drug marketing in the U. S. will also be covered. Why should you attend: Anyone who wants to market OTC drugs in the U. S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/ webinar. It will provide background for OTC Drug labeling regulations and an understanding of how to comply with FDA requirements. Potential FDA  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ...itute 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, and 40 subcategories of operational risk * What to look for in taking a holistic and systematic approach to op risk *  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...

Food Traceability Program and Efficacy Verification - Webinar by GlobalCompliancePanel ...BRC fundamental clause 5. 0, SQF item 4. 5, 9 CFR will be covered. The purpose of traceability and its value to the brand will be explored. The resources necessary to achieve an effective result will be presented. A customer perspective on the importance of product traceability from a customer perspective will be shared with the attendees to bring justification for team support of these time  more...

Basic or Core Java Long Term ...d in Basic Java Curriculum, following topics will also be covered * Enums in Java * Garbage collection in Java o How JVM handles garbage collection o Islands of Isolation * Inner classes in detail o Inner Class o Static Inner Class o Method local Inner Class o Anonymous Inner Class * Concurrency in Java  more...

Records Management 5 - Additional RM Program Components - On-Demand Webinar ...ed to develop an effective and efficient program. Topics covered include: vital records protection; choosing the right medium or mix of media for storing the records; scanning records; policies and procedures; privacy; placing records on hold for litigation; and managing offsite storage. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20  more...