Companies Web-based Seminars

Call Center Social Media Certification - Live Online - May 9-11 2012 ...or in history, resulting in fundamental shifts in the way companies communicate and interact with consumers. This course provides the practical knowledge and insights required to establish objectives and strategies and to properly select the social media platforms to engage consumers, while monitoring and measuring the results of these efforts. Live Online Call Center Training Our live  more...

Call Center Social Media Certification - Live Online - October 3-5 2012 Social media represents one of the most significant changes in consumer media behavior in history, resulting in fundamental shifts in the way companies communicate and interact with consumers. This course provides the practical knowledge and insights required to establish objectives and strategies and to properly select the social media platforms to engage consumers, while monitoring and measuring  more...

MOC 8691 - Fixed Assets I in Microsoft Dynamics GP 10.0 The Microsoft Dynamics GP Fixed Assets training class delves into the accounting cycle and the processes required to enter, depreciate, and retire fixed assets. This course shows how to perform additional functions such as changing asset information, mass changes, partial transfers, partial retirements, and retirement undo.A thorough understanding of these topics allows companies to keep accurate  more...

Better Methods To Control Tools Fixtures in Production Manufacturing ANYTHING requires tools, fixtures and supplies; in addition to people, machines, materials and methods. And while most improvement initiatives focus on production methods and material availability, it is often the tools and fixtures that cause manufacturing disruptions, sometimes leading to shipping delays and customer dissatisfaction. How many times have you been ready to produce,  more...

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

The Most Important Metrics For Measuring Supply Chain Performance ...ommon supply chain metrics observed in many manufacturing companies include: a Inventory Turns or Days-of-Supplya metrics that describe the efficiency or inventory and use of working capital. a Cycle Timea the elapsed time to complete an activity or a set of activities. Common cycle time metrics include: a Customer Order Promised Cycle Time a Customer Order Actual Cycle  more...

How to Factually Evaluate Critical Supplier Performance and Risks ...re creating substantial risks within their supply chains. Companies are discovering that sourced-material disruptions can and often do, result in dramatic and unfavorable impacts to material delivery reliability, total material cost and received material quality. GDI's Comprehensive Supplier Performance & Risk Assessments provide manufacturing & distribution companies with a proactive  more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing You are invited to attend the Manufacturing Executive Institutea ™s FREE February 2011 3rd Thursday - a Operations Improvement webinar, A Case for Routine Use of Statistical Process Control (SPC) in Manufacturing. Statistical Process Control is a term that describes a process for predicting failures and methodically determining the underlying cause(s) before the predicted failures can  more...

Demystifying the Calculations of Efficiency Utilization and Productivity ...w values derived from the formulas can be altered and how companies can benefit from the CORRECT understand of these terms. We will clearly show participants HOW to calculate these values and WHEN to use the results of the measurements. Though this webinar presents a seemingly simple topic, the correct understanding and use of efficiency, utilization and productivity can create a profound  more...

How to Calculate the Impact on Total Factory Costs from a One Percent Change in Planned Load ...ed Load. The largest cost driver in most manufacturing companies, outside of the cost of direct material, is underutilization of semi-fixed and fixed costs. These costs are the aggregated expenditures on plant, property, people and equipment (PPP&E). For manufacturing companies to grow and sustain success, knowledge of what a 1% change in volume does to utilization and incremental fixed  more...

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

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

A Better Method for Cross Training Production Personnel ...Better Method for Cross-Training Production Personnel. Companies that take cross training of production personnel seriously report as much as a 30% fewer direct labor employees than exact peer companies. They also report faster cycle times, higher fill rates and lower customersa ™ backorders. This is because the people working in the production environment are substantially more  more...

Key Steps for Risk Assessment - Webinar By GlobalCompliancePanel The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as  more...

Master Verification Validation Planning under US FDA CGMP ICH Q-series and ISO 13485-14971 Requirements - Webinar By GlobalCom FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. Wednesday, March 21, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Leadership - In the Non-Leadership Position - Webinar By GlobalCompliancePanel This webinar will provide valuable guidance to personnel in regulated companies who are in roles viewed as merely support to those in formal leadership positions. Wednesday, December 7, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Responding to FDA 483s - Webinar By GlobalCompliancePanel Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. Wednesday, November 30, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar B This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

The FDA Inspection Process From SOP to 483 - Webinar By GlobalCompliancePanel This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel This webinar will update personnel at medical device companies on the ISO 14971 standard and point them to the additional information available in the document under the informative annexes. The information will assist in meeting various national and global regulatory requirements for medical devices.  more...

SAP FICO Online Competency Development Training program ...arious versions US, Canada and India for major Consulting companies like Siemens, DELLOLITE, etc. MODULES COVERED IN THIS TRAINING: 1. Introduction to SAP R/ 3 2. Financial Accounting Basic Settings 3. Enterprise structure/ Fiscal Year/ Posting Period/ Field Status variant 4. Posting keys/ Chart of Accounts/ Assignment of Chart of Accounts/ Account Group 5. Retained Earnings/  more...

SAP BOBJ with BW integration Online Competency Development Training program ...5, BI 7. 0 NW 2004S in US and Canada for major Consulting companies like CGI, DELLOLITE, etc. MODULES COVERED IN THIS TRAINING: Module 1. Data warehousing/ Dimensional modeling & SAP BW 7. 0 Concepts Module 2. Database Concepts needed for Data warehousing Module 3. BOXIR3 Architecture Module 4. Universe Design Module 5. Web intelligence Module 6. Crystal Reports Module 7.  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...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...tures, that can withstand legal review in a court of law. Companies may try to say they are using "hard copies" as their controlled documents, but this is increasingly becoming a wrong belief as employees use the electronic versions to make and implement cGMP decisions. Regulatory auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products-GCP This webinar will provide valuable assistance and guidance to device companies in involved in commercialization of combination products.  more...

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare by GCP This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

Emotional Intelligence What it is and Why it Should Matter to You by TrainHR The most important "e-term" you may learn in 2011 is emotional intelligence. Experts say it can make or break careers and elevate executive leadership to higher levels of success, so what are the best moves and worst emotional pitfalls you can make? Learn from executive coach and nationally acclaimed author Arnold Sanow what it is and why it matters to the success of executives and the companies  more...

Root Cause Analysis and Documentation Requirements for CAPA - Webinar By GlobalCompliancePanel ...companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural environment that often lies at the root  more...

Understanding and Implementing USP 1058 Analytical Instrument Qualification - Webinar By GlobalCompliancePanel ...the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for analytical methods there are no clear standards for equipment qualification. This has changed.  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel ... 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 an analysis over the major change or the series of smaller  more...

Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel This webinar will present how organizations can pursue continual improvements and address the concerns of non-conformances and develop corrective/ preventive actions to prevent the repetition of these occurrences in the future. Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...e discussed. Why you should attend: Increasingly U. S. companies are going global and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel Overview: This webinar will provide an overview of process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ... and is also a key source of regulatory problems. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can line operators' brains be engaged by the use of such simple yet powerful tools? Use RCA to facilitate a closed-loop problem resolution  more...

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

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel ...e 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 of the computer technologies. Part 11 is a regulation that regulates the technology when it  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems. Case studies  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...ices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters and inspectional observations. The presentation will address some common sense approach to this dilemma without going overboard; such as having V&V plans and processes that clearly define the completion criteria for a product or process step; and to match the V&V  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel ...companies are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue. Internal Audits show the production controls system compliant, yet again FDA writes the firm up. This webinar will review the production records  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...idation evidence. These issues are prompting life-science companies to search for ways to streamline and centralize their validation projects. When deciding on whether or not a Test Management Tool should be implemented, companies need to realize that the implementation of the Tool will be similar to an implementation of any regulated application, therefore all applicable SDLC documents,  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP Overview: The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current 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  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...quipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify test and document. For easy implementation, attendees will receive: * 4 SOPs o User Requirement Specifications (URS) for analytical equipment  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel Overview: The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested. Of course, there are other reasons for performing a FMEA. FDA requires risk assessment (hazard analysis) but a FMEA conducted late in the product development process  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...the inspectional process. It is clear that pharmaceutical companies should be proactively considering the implementation of a Pharmaceutical Quality System. Most people are still trying to figure out what a Pharmaceutical Quality System is. Many of the components of a Pharmaceutical Quality System are in place in most companies. The various FDA and ICH guidance documents provide significant  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W Overview: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...gical methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel ...g the Risk Management Report and release of the product. Companies have not had methods in place to perform this activity, and although some information appears in ISO 14971, there is not sufficient guidance on how to perform Overall Residual Risk Evaluation. Areas Covered in the Session: * Choosing the Evaluation Team * Determining the Evaluation Process * What documents  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel Overview: Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ..." was issued in May, 1987, and since then, medical device companies have struggled with process validation. Regulators believe through careful design and validation of the process, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process reduces the dependence upon in-process and finished  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ... to the QSIT. It is thus imperative that all regulated companies have an in-depth knowledge of this system, to enable them to prepare for the inspection. Delving into each and every section of the QSIT, this webinar also includes straightforward, helpful methods for incorporating it into your companya ™s ongoing quality system. Why you should attend: If you don't know what the FDA  more...

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

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ... implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III. Areas Covered In the Seminar: * Create and use a  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...his practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote off-label may be responsible for large plaintiffs' verdicts in products liability cases that arise from the off-label uses  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ... suppliers of services and products / components. How can companies address the FDA's stated desire to require "on-site" audit of all Pharma suppliers? Expectations for meaningful, results driven actions that addresses and resolve any underlying compliance issues or product problems are increasing among regulatory agencies worldwide. To meet the new regulatory climate and be competitive,  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel .... To meet this new regulatory climate and be competitive, companies need to continually reevaluate their change control system and its impact on all areas of a companya ™s cGMP activities. Why you should attend: The last few years have seen an increase in product recalls. For this and other reasons, the U. S. FDA has come under increasing negative public scrutiny. High profile drug  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...hoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. There will be no return to the past. Rather than be caught unprepared, proactively address these trends, and start to address areas of known  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel ...ler place. Trade boundaries are disappearing, and many companies have subsidiaries around the world. Multi-national corporations needed a simpler way to put together their consolidated financial statements. Already Australia, most of Europe, and many other countries have adopted International Financial Reporting Standards. Canadian companies are in the midst of the changeover and the U. S.  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...e 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 reports are showing that the FDA inspectors are focusing on electronic signatures and  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...e 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 * Defining Good Requirements * Prioritizing Records * Applying the Regulatory  more...

Labeling Requirements for Dietary Supplements - Webinar By GlobalCompliancePanel ...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 supplements, requirements for inner and outer packaging, and claims  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...ot') rationale. Why should you attend: The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities. The company is held fully responsible for deciding when a new 510(k) filing is warranted. Growing high-profile field problems indicate that change control and ita ™s effect on regulatory review activities are not yet fully utilizing the power of  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e. g., MS-Excel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected under the CGMPs and other guidance documents for such  more...

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

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel ...heir own audits. Without passing scores on these audits, companies are losing current accounts and are denied access to new accounts and business. Many organizations are new to the process of audits and associated standards. Thus, they are seeking out expensive consultations and/ or are requesting pre-assessments to prepare for audits. In order to work cost effectively, allocating resources  more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ...tions 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 CAPA is a very important process so it is always inspected as a part of routine  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ... Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA, EMA, and AAMI regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include: * Validation managers and personnel  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...ns of dollars were lost to the entire industry. Insurance companies and the federal government are focusing on assessing food safety risks in efforts to protect the public from death defying illnesses, protect the industry from huge financial losses and protect the nation from dangerous imports. Risk assessment and control is not magic but represents a critical component of any operational  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. The employees who will benefit include: * QC managers and personnel * QA managers and personnel *  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ...nned 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 awaited next step for Part 11 and nevertheless it came as a surprise to the industry.  more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel ... Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA, EMA, and AAMI regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include: * Engineers involved in water system  more...

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

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ... remediation efforts. Why should you attend: Each year companies are to perform a complete review of their quality management system and its ability to meet the current GMP's. To add to the urgency, there has been a major shift in the emphasis of the U. S. FDA cGMP compliance audits, clinical trial expectations, product submissions and company response requirements. In short, all regulatory  more...

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

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

Root Cause Analysis Shutting Down the Alligator Farm - Webinar by GlobalCompliancePanel ...companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural environment that often lies at the root  more...

Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - Webinar by GlobalCompl This interactive one-day seminar details how to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. Nearly every computerized system used in laboratory, clinical, manufacturing 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  more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel ...O 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ... labeling information. However, in limited circumstances, companies can revise or supplement their warning labels prior to FDA approval (through changes being effected (CBE) supplements) to ensure consumers are immediately made aware of newly discovered risks. The labeling regulations, which became effective in late September 2008, clarify that a manufacturer can make unilateral pre-FDA  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort 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..."  more...

Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by Global ...ed in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost  more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan ...-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 employ equipment / process DQs,  more...

Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar by GlobalCompliancePanel ...companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol.  more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar b Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and  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 FDA's new 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...

Signal Detection and Case Processing Business Process Optimization in Pharmacovigilance - Webinar by GlobalCompliancePanel This course will describe how to assess and optimize pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the  more...

Project Management for FDA-Regulated Companies - Webinar by GlobalCompliancePanel ...companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and ot Three of the most common tools will be discussed. One very simple approach using common Excel- or Word-type PC applications programs that can be used immediately. Regular use of a few simple but  more...

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

Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel ... validation. It is also one of the most common reasons companies receive 483s and warning letters. Conversely, successful validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your organization How do we get there? After we have a clear understanding of the  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part On July 8, 2010, the FDA announced 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  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel ...tigations and CA/ PA. This webinar will provide regulated companies the core principles and practices needed to implement an effective and efficient CA/ PA process. This presentation will begin by defining risk in compliance and the methods, which can be used to mitigate risk. One of the methods defined by the regulators and the industry is "Corrective Action / Preventive Action" otherwise  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel ... issued the Medical Device Quality Systems Manual to help companies implement the Quality system Regulation. Chapter 7 discusses the role of calibration systems in the QMS and helps define the regulatory expectations. ISO 10012: 2003 Measurement management systems - Requirements for measurement processes and measuring equipment, a document in the ISO 9000 family, specifies quality management  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...

PCI Data Breaches What happened What may have prevented it What if it happens to you ...afety in numbers. Criminals do not necessarily attack big companies; they go after whatever is easy. The cost of responding to a breach is getting more expensive each year. In this webinar you will learn about the current threat environment, how some of the biggest data breaches of recent years could have been prevented, how to reduce your risk of a breach and what to do if the unthinkable  more...

Application Controls throughout the Life Cycle of Application Systems GlobalCompliancePanel brings a new webinar on the topic of Application Controls throughout the Life Cycle of Application Systems. Webinar will be on March 16, 2010. Webinar will be presented by Bernice Russell Bond. Miss. Bond is the President of BRUSSELL Consulting, Inc (BCI), Bernice brings over fifteen years of business operations, risk management, audit and compliance experience. She has  more...

Foreign Material Control GlobalCompliancePanel brings a new webinar on the topic of Foreign Material Control. Webinar will be on March 9, 2010. Webinar will be presented by Melinda Allen. Ms. Allen is a Food Safety and Quality Consultant in the Food Industry. Melinda has had a long and dedicated career of Quality Assurance and Food Safety leadership with companies such as YUM Brands and Quiznos.  more...

Setting Up and Running a Tougher Supplier Audit Program GlobalCompliancePanel brings a new webinar on the topic of Setting Up and Running a Tougher Supplier Audit Program. Webinar will be on March 2, 2010. Webinar will be presented by John E Lincoln. Mr. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U. S. FDA responses.  more...

Introduction to Professional Organizing - Webinar ...ynamic and growing industry. Individuals, families and companies, large and small, welcome assistance from Professional Organizers and as our industry matures, the need for more of us that instinctively know how to turn chaos into control increases dramatically. This webinar has been created to answer the many questions that must run through your head as you explore this industry and to  more...

ONLINE TIBCO TRAINING IN HYDERABAD ...loping relationships with leading and emerging technology companies. These relationships help us deliver the latest market leading research and innovative solutions to our clients. Named as 'one of the Top 50 Software Development/ Consultancy Firms in Tampa , Transient IT Services has achieved aggressive growth while maintaining the highest levels of customer satisfaction. Almost 75% of our  more...

ONLINE JAVA TRAINING IN HYDERABAD ...loping relationships with leading and emerging technology companies. These relationships help us deliver the latest market leading research and innovative solutions to our clients. Named as 'one of the Top 50 Software Development/ Consultancy Firms in Tampa , Transient IT Services has achieved aggressive growth while maintaining the highest levels of customer satisfaction. Almost 75% of our  more...