Product Web-based Seminars

Listening for Tech Entrepreneurs ...product that they don't pay attention to what is happening around them, then they wonder why they're not getting funding, a market, or customers. A major factor in this challenge is the lack of well developed listening skills. Many tech entrepreneurs have no idea how they listen, let alone if their listening habits are appropriate for the situation they are in. This workshop will  more...

MOC 6231 - Maintaining a Microsoft SQL Server 2008 Database This SQL Server training class provides students with the knowledge and skills to maintain a Microsoft SQL Server 2008 database. The class focuses on teaching individuals how to use SQL Server 2008 product features and tools related to maintaining a database.This SQL Server 2008 class is intended for IT Professionals who administer and maintain SQL Server 2008 databases.  more...

MOC 6232 - Implementing a Microsoft SQL Server 2008 Database This SQL Server training class provides students with the knowledge and skills to implement a Microsoft SQL Server 2008 database. The class focuses on teaching individuals how to use SQL Server 2008 product features and tools related to implementing a database.This SQL Server 2008 class is intended for IT Professionals who administer and maintain SQL Server databases.  more...

MOC 2823 - Implementing and Administering Security in a Microsoft Windows Server 2003 Network This Windows Server 2003 training class addresses the MCSA and MCSE skills path for IT Pro security practitioners, specifically addressing the training needs of those preparing for the 70-299 certification exam: Implementing and Administering Security in a Microsoft Windows Server 2003 Network. The primary product focus is on Microsoft Windows Server 2003 based infrastructure solutions but will  more...

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

MOC 2780 - Maintaining a Microsoft SQL Server 2005 Database This SQL Server 2005 training class provides students with the knowledge and skills to maintain a Microsoft SQL Server 2005 database. The course focuses on teaching individuals how to use SQL Server 2005 product features and tools related to maintaining a database.This class is intended for IT Professionals who want to become skilled on SQL Server 2005 product features and technologies for  more...

MOC 2779 - Implementing a Microsoft SQL Server 2005 Database This SQL Server training class provides students with the knowledge and skills to implement a Microsoft SQL Server 2005 database. The course focuses on teaching individuals how to use SQL Server 2005 product features and tools related to implementing a database.This training class is intended for IT Professionals who want to become skilled on SQL Server 2005 product features and technologies for  more...

How to Dramatically Improve the Quality of Your Shipment ForecastsTechniques to Improve Forecast Inputs ...ipment forecast represents independent demand for company product which in turn drives the Master Production Schedule (MPS) process. Start with an inaccurate shipment forecast and a poor performing MPS is sure to follow. Continue with a poor forecasting process and inventory will surely balloon at the same time customer shortages increase. When forecasting is an afterthought, no one is happy!  more...

JIRA Fundamentals Training Course ...more effectively. The material covers all features of the product from an end-user's perspective, and provides a solid foundation for users with all levels of experience, since it explains the most effective ways to use JIRA and some handy tips for getting the most value out of the software. Attendees from this session will become proficient with creating issues, using the workflow, assigning  more...

Integrative Activity Based Costing Leadership An Overview of Bottom Up Cost Accounting ...only used value engineering tools, a new perspective of product cost can be developed. 2. To demonstrate how any standard cost accounting system can be made to calculate allocations based on activities instead of labor dollars. 3. To provide executives with an overview of how ABCA can motivate all levels of employees to self-identify, self-prioritize and self-eliminate waste  more...

Should Under-Utilized Capacity Costs Be Included in Work Center Burden Rates ...en Rates?" When your factory is underutilized, your productsa ™ incremental fixed cost is increased. As your factory gets more utilized, the allocated incremental fixed-costs decrease, thus increasing your companya ™s gross margins. But what happens to product gross margin when sales drop and factory UNDER-UTILIZATION increases? Plant, property, equipment and people do not  more...

How to Calculate the Impact on Total Factory Costs from a One Percent Change in Planned Load You are invited to attend the Manufacturing Executive Institutea ™s September 2010 3rd Thursday - Operations Improvement Series FREE webinar, How to Calculate the Impact on Total Factory Costs From a 1% Change in Planned 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  more...

Three New Segmented P and Ls That Will Shake Your Understanding of Product Cost This 1-hour FREE webinar presents three new profit and loss statements that are the direct result of rethinking manufacturing cost accounting. These new formats are sure to forever change your thinking about how value is created... and destroyed... in a manufacturing enterprise.  more...

How The Manufacturing Industry Can Save Americas Economy ...is is more than a feeling. It is supported by industrial productivity data, product ramp-up analyses, commercial employment statistics, comparative trade balance values and international industrial liquidity data. After 60 years of GDP growth and increasing industrial competiveness that defined our land as THE land of economic opportunity and upward mobility, the US now finds it increasingly  more...

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

Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar By GlobalC ...upplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An update on FDAa ™s draft guidance for New Dietary Ingredients  more...

The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND Comparing the Content and Agency Expectation - Webinar By G This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective  more...

Important Sterilization Information for Product Developers - Webinars GlobalCompliancePanel Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package. Tuesday, November 29, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Conducting Successful Product Complaint Investigations - Webinar GlobalCompliancePanel This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. Thursday, December 1, 2011 10: 00 AM PST | 01: 00 PM EST  more...

CAPA Failure Investigation and Root Cause Analysis to Meet FDA Expectations - Webinar By GlobalCompliancePanel Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. Wednesday, November 16, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel ...products have established myriad control programs to comply with FDA regulations regarding control of product contaminants. However, due to variable emphasis being placed on each of these control elements by FDA auditors, most manufacturers have developed their programs in a piecemeal fashion. Thus, each element in a manufacturer's control program has been implemented without regard for the  more...

Designing an Effective Cleaning Validation in todays Regulatory Environment - Webinar By GlobalCompliancePanel This webinar concentrates on designing effective cleaning validation studies. Key benefits of this seminar include: Learn what steps should be followed. Identify critical parts of cleaning validation process. Achieve satisfactory inspections. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls.  more...

SAP FICO Online Competency Development Training program ...ing 40. Internal Orders 41. Profitability Analysis 42. Product Costing- Basics Attendees also learn: 1. Resume Preparation Guidelines and Tips 2. Mock Interviews and Interview Preparation Tips should Here are some videos explaining how we conduct our training program, use Training Blogs and Google documents to communicate with our trainees and share the Assignments, Video  more...

Establishing a Reduced Testing Program for Pharmaceutical Medical Device Components ...product manufacturer to reduce testing of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing. Industry practice in the performance of reduced testing has resulted in new and modified expectations and requirements. The benefits of systematic reduced  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...re validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable cGMP Part 11 software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address  more...

Requirements of validation and control of EO Sterilization - Webinar by global compliance panel Sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...lization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness. Why should you attend: Radiation sterilization validation is a topic that results in many audit observations from the FDA and international  more...

CAPA Challenges and FDA Expectations - By GlobalCompliancePanel CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.  more...

Failure Mode Effects Analysis FMEA - The Tool of Choice to Improve Product and Process Reliability and Efficiency While Reducin ...chnique to improve the quality, reliability and safety of products and processes in a proactive manner. It has been used successfully for over 60 years in very type of industry and in all stages of product development, process improvement projects. It helps to increase customer satisfaction, by proactively addressing failures that keep us from meeting critical customer requirements in  more...

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

Human Behavior in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel his live webinar concentrates on identifying good and bad cleanroom behavior. It provides training in cleanroom contaminants and how they are affected by humans. The key benefits of this course are: In-dept understanding of cleanroom contaminants. Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances.  more...

Introduction to Master Validation Plans - Webinar By GlobalCompliancePanel This webinar provides an introduction to the creation, implementation, and maintenance of Validation Master Plans. Key benefits of this seminar include: Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls. Take a holistic  more...

What to Expect and How to Prepare for FDA Inspections - GlobalCompliancePanel As recent headlines demonstrate, non-compliance with US Food & Drug Administration US FDA laws and regulations could cost your firm millions. In addition to significant revenue losses, violative US FDA inspections may also lead to injunctions, consent decrees, warning letters, FDA 483 's Notice of Inspectional Observations, product non-approvals, import detentions, recalls, criminal  more...

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

Webinar on Specification Development - By GlobalCompliancePanel A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract.  more...

Good Documentation Practices for Laboratory Operations Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory personnel need to be informed of these requirements, recognize their significance to their job and be aware of the  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ... 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 the TF/ DD is moving in the direction of the DHF.  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ... of process validation and its application to all medical products. They will better understand the importance of their role not only in maintaining the process but also in helping diagnosis and treatment of patients more consistent. Why Should You Attend: Process Validation (PV) has been a widely discussed and debated "phenomenon" in FDA regulated industries for many years. Do you know what  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ...facturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...re validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address software that is:  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective and/ or preventive actions, and do proper impact  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...lysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...life sciences manufacturers engaged in various aspects of product complaint investigations. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ... 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..." The statement clearly reflects the renewed FDA  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...d for people in manufacturing who are involved in setting product specifications, setting up acceptance plans, performing acceptance activities, and supply chain management. Attendees should have knowledge of manufacturing process that includes acceptance activities such as incoming, in-process, and final acceptance. This typically includes: * Quality Engineers * Production and  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ... the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what is meant by "list of components",  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ... specific components to ensure control of investigational product, data integrity, oversight of investigators as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections. It will be important to see what the FDA  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...Reduce rates of batch rework and rejections. * Avoid product recalls. Why should you attend: Since humans are the major source of contamination in cleanrooms, special care must be taken to choose and provide proper garments to minimize the human impact on cleanroom quality. Gowning systems are varied in material, composition, coverage, and control capabilities. The use and donning of  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...tions more easily. * Higher assurance of new medical product approvals. * Minimize nonconformances. * Reduce rates of batch rework and rejections. * Reduce cleaning-related environmental contamination issues. * Avoid product recalls. * Understand industry standards in cleanroom cleaning Why should you attend: Cleanroom cleaning processes and methods have been  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...ered high risk systems because they have a high impact on product quality. Despite the fact that equipment 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:  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel ...ssment (hazard analysis) but a FMEA conducted late in the product development process is largely a documentation exercise - rarely does this FMEA affect the design. Emphasis is placed on enhancing the power and benefits of FMEA for your organization by avoiding common pitfalls and concentrating efforts toward the real value of the FMEA process. Areas Covered in the Session: * What is  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel Overview: ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices. According to the FDA, if it isn't written down, it didn't happen. As  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...es concepts such as building quality into the process and product. By the end of this webinar, participants will better understand what is included in a Pharmaceutical Quality System, how their organization can transition to this type of a quality system and how the changes will impact them. Areas Covered In the Seminar: * The transition from a quality control focus to a quality  more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...mediates, API, drug substances, medical devices, finished product, and in-house manufactured components. It will describe a well-defined Quality role, identify requirements for resources, and outline the expectations for documentation review. Additionally, the course will look at the creation of disposition packages for approval and rejection of materials, and cover changes in disposition  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel ...e 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 released  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel ... occurs at the end of the development cycle to assure the product risk meets the risk acceptability criteria prior to issuing the Risk Management Report and release of the product. 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  more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel ...fication bodies with the information they need to certify products to the Third Edition in the most efficient manner. By preparing in advance for certification reviews and testing, the product should move through the process quickly and efficiently. We will especially look at the risk management documentation requirements and how to provide the information requested. Why you should attend:  more...

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

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard. While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U. S. drug. API, and biologics  more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel Overview: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs). Because many RMM  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel Overview: This presentation will go over the steps required for your recruiting process to be successful. The ability to bring in (recruit) on-time study participants whether they be 'normal healthy adults' or patients with the condition being studied is essential for a CRO, a site, a CPU/ CRU for conducting on-time study starts with the full complement of volunteers. For this reason the  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...e finished device testing is often insufficient to assure product quality. In some cases, destructive testing is required to show that the manufacturing process is adequate. End-product testing may not reveal product variations that can occur which may impact safety and effectiveness. Areas Covered In the Seminar: * What is Validation? * When should it be used? * How does  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ...te facilities are available to support manufacture of the product. It is therefore important to present 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  more...

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

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

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...ess of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned executed, and visibility maintained. There is a  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...s required to resolve any underlying compliance issues or product problems that are increasingly seen by regulatory agencies and consumers worldwide. 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  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...ive publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and recent public concern over insufficient oversite of new product introductions (and grandfathered product) by means of the 510(k) system. Business continues to "shoot itself in the foot", including once highly respected companies. All this affects the  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...ctions more easily * Higher assurance of new medical product approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls * Identify and control the key contamination concerns for your company * Take a holistic approach to contamination control * Achieve synergy among control programs Why you should attend:  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...ctions more easily * Higher assurance of new medical product approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls Why you should attend: Regulatory agencies expect manufacturers to periodically demonstrate that cleanrooms and controlled environments perform according to their design specifications. In addition,  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...shows that the process can consistently produce a quality product. Writing and executing good process validation can be a daunting task given the complexities of today's biotech and pharmaceutical processes. Guidance's are helpful in writing process validation protocols and deciding what can be, or should be, varied in the process. The notions of critical process control parameters and control  more...

SAP Profitability Analysis COPA SAP Expert Training on Controlling and Profitability Analysis Modules ERP -- SAP Area -- Finance Specialization -- Controlling and Costing Course -- CO-PA Number of Hours -- 30 Hours Please contact for Demo Class sriman@ficoanalyst. com Expert Advice, Blueprint Discussion, Configuration, Process Executuion, Hands on Training, Testing Templates, Cutover  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...utomating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable level of effort. However, these systems can get bogged down during implementation due to the need for excessive validation testing and  more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel ... illustrated and the appropriateness during the different 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  more...

Labeling Requirements for Dietary Supplements - Webinar By GlobalCompliancePanel ...mmerce websites. Why should you attend: * Avoid product recalls * Be in compliance with labeling requirements * Avoid wastage in regulatory fines * Improve your profitability Areas Covered in the Session: * Labeling defined * Current compliance labeling issues * Labeling requirements * How to design a labeling program that is compliant *  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the 510(k) process. A review of recent information  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...oftware 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 and Document * Proper Risk Allocation of Scarce Resources Who Will Benefit: * Senior management in Drugs, Devices, Biologics, Dietary  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ...ion 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 common Excel- or Word-type PC applications programs that can be used immediately. Regular use of a  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel ...on of equipment often contributes foreign material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as customer order fulfillment. A systematic approach to maintenance is critical to operations, quality and safety. Areas Covered in the Session: * How to prepare an audit policy and program * A sample checklist for documenting  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in  more...

Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel ...on of equipment often contributes foreign material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as customer order fulfillment. A systematic approach to maintenance is critical to operations, quality and safety. Areas Covered in the Session: * Preventive Maintenance * Corrective Maintenance * Post repair sanitation  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...armaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in  more...

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

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ... FDA cGMP compliance audits, clinical trial expectations, product submissions and company response requirements. In short, all regulatory areas are under evaluation by the FDA, and need to be revisited by a company's QA/ RA and its senior management. There is "no business as usual". This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives,  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global ...dance documents? * What are some Pro and Cons of the product lifecycle for pharmaceuticals * Is the Quality Systems Approach really "Compliance in Sheep's Clothing? * Who will win the GMP battle-Quality or Compliance Who Will Benefit: * Quality Unit Supervisors/ Managers/ Directors * Manufacturing Supervisors/ Managers/ Directors * Support Functions to Quality  more...

The Process Approach to Auditing - Webinar By GlobalCompliancepanel Overview: The structure of ISO 9001: 2000 provides a focus on the processes that comprise the quality management system (QMS). Also, the general requirements laid out in Clause 4. 1, the foundation for auditing a process-based system, are taken up for discussion at this webinar. There are eight basic processes that an organization must have to function effectively. These are: *  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel ... Class I, IIa and IIb, and "Design Dossier" for class III products., the files are retained on the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body. Dossiers have to be submitted to the Notified Body for review prior CE-Marking of your product. It is not necessary to include all documents in the design dossier which  more...

Know Your Customer - The DEA Due Diligence - Webinar By GlobalComplaincePanel This training will cover several recommendations to improve Due Diligence when distributing Schedules II through V controlled substances and regulated chemicals to your customers and what steps can be taken to prevent the illicit use or diversion of any product sold to a customer. As a firm handling these products, you will get a better understanding of what is required from a DEA registered  more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel ...production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success, and avoid those frustrating, embarrassing discussions of missing or doubtful data, employees recognize and must follow Good Documentation Practices (GDP). These practices apply to all pharmaceutical and medical  more...

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

How to Prevent Food Safety Problems Using Your Current Quality System - Webinar by GlobalCompliancePanel ...hain as marketers have worked diligently to improve how a product looks with relatively little regard to other factors. How a product looks is a marketing approach and provides no health, taste or safety protection since these more primary quality aspects impact overall quality. Early attempts at "food safety" evolved at times when little or poor technology was available to the non-existent  more...

Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel ...d protect the image and reputation of the company and its products. This presentation will help you to have a basic idea how to develop an effective crisis management program for product recovery and product recall. Many crisis situations can ruin your business in a short period of time when it took a longer time to build. Knowing the food safety practices in your facility is ongoing and you  more...

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

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

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety  more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ... 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..." The statement clearly reflects the renewed FDA  more...

BRC Risk Analysis - Webinar by GlobalCompliancePanel Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals. Bringing consciousness and tangibility to this process is the challenge often faced. A practical guide documenting the process will be the topic of this training. This presentation will take you step by step through the creation of each type of risk assessment required by the BRC. Process and  more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G ...product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product Determine which Center will review my combination or non-combination product? These topics and more will be addressed during this Webinar, including recently  more...

Value-Adding Internal Auditing Learn how to get your Internal Audit System to promote improvements and add real value to your or ...product company. It provides management with information about how effectively a company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical GMP regulations and other quality standards. This course provides information to increase an auditor's ability to audit in a professional and  more...

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision"  more...

Food Traceability Program and Efficacy Verification - Webinar by GlobalCompliancePanel ...Product traceability requirements for meeting Food Safety and Quality standards as required by 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  more...

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

Project Management for FDA-Regulated Companies - Webinar by GlobalCompliancePanel ...ion 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 powerful tools will virtually eliminate  more...

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel ... recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell  more...

Important Sterilization Information for Product Developers - Webinar by GlobalCompliancePanel ...Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package. This presentation will provide information that can be used by R&D Engineers and Product Developers to aid them in  more...

Advancements in Simulation Series Webinar 4 Analysis Optimization ...y webinars to learn about advancements in software driven product design testing. Engineers will gain insight into how to use the latest FEA software innovations to help meet business objectives such as reducing material costs, time to market and field failures. NEi Software FEA experts will provide specific applications for the aerospace, automotive, civil, manufacturing, marine,  more...

Advancements in Simulation Series Webinar 3 Nonlinear Analysis ...y webinars to learn about advancements in software driven product design testing. Engineers will gain insight into how to use the latest FEA software innovations to help meet business objectives such as reducing material costs, time to market and field failures. NEi Software FEA experts will provide specific applications for the aerospace, automotive, civil, manufacturing, marine,  more...

Leadership in Manufacturing Contamination Control ...must take leadership in contamination control support for production because it is the hub of the necessary technical expertise. This broad manufacturing support role covers many areas, including routine raw material and product testing, disinfectant/ sanitant qualification, water and compressed gas testing, environmental monitoring, microbiological a awareness traininga of production  more...

Specification Development GlobalCompliancePanel brings a new webinar on the topic of Specification Development. Webinar will be on March 23, 2010. Webinar will be presented by Melinda Allen. A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract. Specifications are a customers greatest tool for ensuring products received  more...

Update on Unique Device Identifier for Device Manufacturers FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely  more...

Validating Radiation Sterilization for medical device industries GlobalCompliancePanel brings a new webinar on the topic of Validating Radiation Sterilization for medical device industries. Webinar will be on March 9, 2010. Webinar will be presented by Mark Roberts. Mr. Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the  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...

Manufacturing Optimization Online Certificate Program Online training One-hour online sessions meet every Wednesday at 7: 00 p. m. Eastern Time. The Manufacturing Optimization Online Certificate Program consists of three modules covering quality management, root cause failure analysis, and cost reduction and optimization. This training features practical, experience-based and proven approaches for rapidly optimizing your manufacturing process. The  more...

Office Organizing - Solutions Systems - On-Demand Webinar Office organizing can provide new or experienced Professional Organizers with a higher income stream than residential organizing can. However, if you are going to be an office organizer, you need to know how to do it well, or your reputation and your clients' businesses may suffer. Join Certified Professional Organizer ® Debra Milne as she talks about about the latest trends, resources and  more...