Industry Web-based Seminars

Struggling to break into Clinical Research Free informative webinar about the CRA profession and the ways to break into the clinical research field. The webinar describes the pharmaceutical industry now and the future of the industry, the CRA job, skills and personality and how to break in the clinical research field. The session is live, so you can ask questions and get answers from the presenter, an experienced clinical research  more...

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

Legal Word Processing Course - Microsoft Word 2007 This comprehensive course focuses on the core formatting elements of Microsoft Word 2003, 2007 or 2010. It provides conceptual and technical learning of the software's advanced features used by international law firm staff to process complex legal documents. The KAS Training Legal Word Processing course was developed by legal trainers with more than 20 years of experience in the legal industry.  more...

Groovy Training for Java Developers This Groovy training course teaches experienced Java developers how to write programs in Groovy that simplify, enhance, and expand their existing systems. The course will be taught by Ken Kousen. Dr. Kousen is an instructor, consultant, and developer specializing in all areas of Java, XML, and, more recently, Groovy and Grails. Over the past decade, he has taught courses and made  more...

Web Development using Grails This Groovy on Grails training course teaches experienced web developers how to use the Grails framework to rapidly create sophisticated web applications. The course will be taught by Ken Kousen. Dr. Kousen is an instructor, consultant, and developer specializing in all areas of Java, XML, and, more recently, Groovy and Grails. Over the past decade, he has taught courses and made  more...

Advanced Oracle SQL Training on Oracle 11g/10g The primary objective of this Oracle training class is to consider advanced subjects and techniques pertaining to the SQL database language. Even professionals experienced in other implementations of the industry-standard SQL language will benefit from the advanced and Oracle-specific features of SQL discussed in this course.  more...

Better Methods for Maintaining Accurate Operation Standards ... home computer. Learn from an expert instructor AND your industry peers! Manufacturing professionals ALWAYS worry that production operation standards are inaccurate. This is appropriate because operation standards are the cornerstone of successful capacity planning, work order control, process flow planning and cost accounting. There are few data elements in a manufacturing company's  more...

How The Manufacturing Industry Can Save Americas Economy America's economy is in trouble and only the manufacturing sector can save it! It is clear that Americaa ™s competitiveness on the global economic stage is diminishing. This 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  more...

Risk Management in the Pharmaceutical Supply Chain - Webinar By GlobalCompliancePanel Supply chains for pharmaceutical products have become increasing complex as the industry has outsourced many non-core activities to third party contractors and sought lower prices for their materials around the global. Tuesday, December 13, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Best Practices in Analyzing and Reporting Financial Outcomes in the Hospital Industry - Webinar By mentorhealth This 90 minute webinar has been designed to dispel the myth that information is not available in the healthcare industry to good and rational financial decisions. Tuesday, November 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Best Practices in Key Financial Metrics - Webinar By mentorhealth Hospital executives have a hard job to do! In attempting to create and achieve an effective strategic plan, there is a great need to determine specific outcomes that will be consistent with the organization's underlying mission, broad policies, culture and accepted industry normsa .But what exactly does this mean? What are the elements that will be instantly recognizable as "a" or "the" key  more...

The Controls for Outsourcing Manufacturing and Testing - Webinar GlobalCompliancePanel ...will be defined and examples throughout the FDA regulated industry will be discussed. Of course, regulatory requirements will be discussed to include the FDA's current thinking about the required controls. Particular emphasis will be given on the importance of understanding the differences between contractors and suppliers. Price List: Live : $245. 00 Corporate live : $995. 00 Recorded  more...

Design History File DHF the Device Master Record DMR and the Device History Record DHR Principles on Lean Documents and Lean Co Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Tuesday, December 13, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Performance Management The Key to the Castle - Webinar By TrainHR This webinar has been carefully designed to ensure an optimum learning experience. We have drawn upon the expertise of many of the best minds in the industry in creating a program that will not only inform, but teach practical skills, as well.  more...

Human Capital Organizational Structure and Human Resources - Webinar By TrainHR This webinar has been carefully designed to ensure an optimum learning experience. We have drawn upon the expertise of many of the best minds in the industry in creating a program that will not only inform, but teach practical skills, as well.  more...

Audits In The Health Care Industry - Getting Ready for an Outside Audit - Webinar By mentorhealth You need to attend in order to control your own destiny. Get involved up front instead of being a "sitting duck". Tuesday, October 11, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Effective Internal Auditing-Making Quality Systems More Efficient for the Medical Products Industry - Webinar By GlobalComplianc The different types of internal audits and how they are approached will be discussed. The Internal Audit Lifecycle will be followed from beginning to end. It will be shown that. Internal audits are not simple exercises to determine compliance to some regulatory standards. Instead, the focus must be on auditing the company's quality system to determine if they are meeting their objectives and are  more...

Draft Guidance for Device Industry and FDA - Postmarket Surveillance - Webinar By GlobalCompliancePanel This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance activities. Tuesday, October 25, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Establishing a Reduced Testing Program for Pharmaceutical Medical Device Components Reduced testing test permits a medical 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.  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 ... Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable cGMP Part 11 software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this  more...

ISO 13485 as a Quality Management System for Medical Devices by GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. 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  more...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration by GlobalCompliancePanel Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and also  more...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration - by GlobalCompliancePanel Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and also  more...

Failure Mode Effects Analysis FMEA - The Tool of Choice to Improve Product and Process Reliability and Efficiency While Reducin ... 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 processes or products. It reduces product development costs operational risk. Join Dr. Anthony Tarantino, a Six Sigma  more...

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel ...es and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old there are still many questions related to the scope and real requirements of Part 11. Attendees of this seminar will learn about  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...mpliance. During this webinar, you will review agency and industry standard expectations of Good Documentation Practices plus see examples of these practices (both good and bad!) as they apply to the pharmaceutical laboratory. Why Should You Attend: Discover what the FDA and EU regulations say about documentation Learn what your signature and/ or initials mean on a document  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ... Services. Areas of high risk, as identified by respected industry organizations, will be identified to ensure that the most significant risks are discovered and adequately prioritized. The risk analysis process will be applied to a simplified example in order to relate the process to a real situation and drive home the usefulness of the process. Areas Covered in the Session: *  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...l personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/ Compliance persons. * Principal Investigators and sub investigators * Clinical Research Scientists (PKs, Biostatisticians, ...) * Safety Nurses * Clinical Research Associates (CRAs) and  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...s and how you would explain it to an "alien" from another industry? Now, this is not to mean that other industries do not practice process validation because they do. It is that in the manufacture of medical products, so much is at stake for the professional and their patient. It is imperative that medical products must perform consistently so that patients can be treated in a predictable  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ... Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...icate that effective root cause analysis is still not the industry norm. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop RCA as an integral part of CAPA, Validation and Quality Management Systems / cGMP  more...

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

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...nducting 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 interest in examining industry compliance with regulations for electronic records and electronic signatures - and  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...l personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including: * Senior Management * Project Managers * CRA Managers * QA/ Compliance persons * Principal Investigators and sub investigators * Clinical Research Scientists (PKs, Biostatisticians, ...) * Safety Nurses * Clinical Research Associates (CRAs) and  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...n issues. * Avoid product recalls. * Understand industry standards in cleanroom cleaning Why should you attend: Cleanroom cleaning processes and methods have been scrutinized by FDA auditors due to their important role in cleanroom management. Poor or substandard cleaning can result in manufacturing delays, nonconformances, recalls, and regulatory action. Therefore it is important  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ... 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 understand ISO 13485 and implement a successful  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...ept of a Quality System was imposed on the medical device industry through the implementation of a regulation - the Quality System Regulation (QSR), 21CFR820, in 1996. It is not clear when and how the FDA will begin to support its expectation for a Pharmaceutical Quality System through the inspectional process. It is clear that pharmaceutical companies should be proactively considering the  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...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ...s sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems. This web seminar will give a good understanding on the regulatory requirements, and it will have recommendations and provide tools for effective implementation. Reference material for easy implementation:  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ... begin issuing 483s immediately. While the medical device industry has been subject to many of the requirements in the new guidance, most pharmaceutical firms and their suppliers have not implemented, and may not even fully understand, the advanced statistical, scientific, and management expectations now demanded by FDA with the release of this standard. Areas Covered in the Session:  more...

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

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...e off-label uses of their products. The pharmaceutical industry has been distributing reprints of scientific and journal articles on off-label uses of drugs for many years now, but the regulations and rules in recent years were burdensome, and the Department of Health and Human Services Office of the Inspector General (OIG) has been diligently pursuing off-label promotion as a form of  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...on. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its selection, audit, use and on-going relations with its suppliers of services and products / components. How can  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...he "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems. Change can be beneficial, but is often the cause of new and even worse problems  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...its of this course are: * In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters * Achieve satisfactory inspections 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:  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...of process validation will be explored along with current industry practices. The recent draft FDA Guidance Document on process validation will be reviewed and case studies will be presented that will allow the attendee to see practical examples of process validation protocols. Areas Covered in the Session: * Recent Guidance Documents * Industry Practices * Examples of  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...gher 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 from the Agency, including last summer's Working Group findings on the 510(k), Vol. I, as well as other goals of the Agency that have already been translated into action in the past year will provide direction in areas  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...tend: Pressure is increasing on the FDA to get tougher on industry. The FDA has responded. * How does that impact companies' use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing? * How can this be addressed? * What does "science-based" mean? * What are current 483 and Warning Letters indicating, and what can we learn  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...ld be done. To date, no guidance document on training for industry has been available from any regulatory agency or official (governmental, nongovernmental or industrial) organization. Unfortunately, this lack of guidance may cause some in industry to think that training is a simple process. However, for training to be an effective and efficient tool that contributes to performance, it must be  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ...erned that the special rules applicable to the healthcare industry prevent or restrict their activities. In fact, the healthcare industry is subject to particularly restrictive rules that impact the manner and method with which they can use social media tools, particularly related to HIPAA and other medical privacy concerns. However, it is possible to pursue a social media strategy while  more...

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

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ... Quality System, and supported in the FDA Guidance to the Industry, Quality System Approach to Pharmaceutical CGMP Regulations. This course will include a discussion of the Deviation System, what should be investigated and the level of investigation. Several tools that will lead to the identification of the root cause will be discussed. These include: process mapping, brainstorming, cause  more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel ...ion and enforcement practices * Recommendations from industry task forces: GAMP/ ISPE guides * Definition of raw data: original records vs. standard electronic formats, paper print-outs * Ensure and demonstrate integrity of raw data * The importance of risk assessment for the management of raw data * Electronic record maintenance during archiving period * Software  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel .... Hundreds of millions 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  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...ations. It should be remembered the regulations came from industry and furthermore, that the regulations are the minimum requirements. When the pharmaceutical GMP's were issued, it was frequently stated that the regulations would result in only a mediocre or average quality system. This is because more emphasis would be placed on meeting the demand of the regulation, than studying the objective  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...arances and proposals and recommendations between FDA and industry * Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting use of predicates, greater authority to rescind 510(k)s, etc. * 510(k) Frequently Asked Questions * Attendees should be prepared to address any issues and challenges as experienced on behalf  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ...for Part 11 and nevertheless it came as a surprise to the industry. Reference material for easy implementation: * 25 recent FDA Warning Letters with part 11 violations. * 15 Case Studies: Implementing Part 11 * Validation templates and examples Areas Covered In the Seminar: * FDA inspections: Preparation, conducts, follow up * Learning from past Part 11  more...

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

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...gher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. A review of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of 101 areas of  more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel ...gher 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) Task Force on the Utilization of Science in Regulatory Decision Making.  more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. 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  more...

Process Verification and Validation - by GlobalCompliancePanel This webinar will provide valuable guidance to regulated 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  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...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...nducting 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 interest in examining industry compliance with regulations for electronic records and electronic signatures - and  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ... decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical studies will be required. You will learn of possible changes in the de novo process that could streamline the clearance process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and  more...

Value-Adding Internal Auditing Learn how to get your Internal Audit System to promote improvements and add real value to your or Auditing is a critical function of a medical 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  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...

Linkedin for online profile development Over 75 million professionals use LinkedIn to exchange information, ideas and opportunities * Stay informed about your contacts and industry * Find the people & knowledge you need to achieve your goals * Control your professional identity online Find past and present colleagues and classmates quickly. Discover inside connections when youa ™re looking for a job or new  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part ...focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and Part 11 compliance. Just from 2007-2010, there have already been more than 30 such warning letters, some with disastrous consequences  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel ...isk. One of the methods defined by the regulators and the industry is "Corrective Action / Preventive Action" otherwise referred to CA/ PA. We will first define what we mean by risk. We will then explore the factors associated with risk in compliance. We will also explore risk causing events and how to address them. A review of risk severity/ level will then ensue. Upon completion of risk part  more...

Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel ...gher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis on proving a company is "in control" to an investigator's  more...

Applying Lean IT Principles to your IT department to identify opportunities to reduce waste and increase efficiency GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 30, 2010. Webinar will be presented by Bernice Russell Bond. Bernice brings over fifteen years of business operations, risk management, audit and compliance experience. She has worked for business, legal, audit, and IT management groups within various industries including  more...

ISO 13485 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation ...pliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 25, 2010. Webinar will be presented by Jeff Kasoff. Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success. ISO 13485 is a wordy standard, drafted by individuals for many of whom  more...

The FDA Electronic Submission Gateway ESG ...pliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 25, 2010. Webinar will be presented by Albert Cefalo. Mr. Cefalo has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. Chuck also conducts in-house training on a  more...

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

Risk Management in IEC 60601-1 Third Edition ...pliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 23, 2010. Webinar will be presented by Edwin L Bills. IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology. This new philosophy has been difficult for test houses and  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...

Process Validation for Drugs and Biologics GlobalCompliancePanel brings a new webinar on the topic of Process Validation for Drugs and Biologics. Webinar will be on March 17, 2010. Webinar will be presented by James Harris. Mr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries  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...

FDA Inspections What to Expect and How to Prepare GlobalCompliancePanel brings a new webinar on the topic of FDA Inspections: What to Expect and How to Prepare Webinar will be on March 3, 2010. Webinar will be presented by James Harris . Mr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60  more...

Online Building Science Series March - August 2010 ...undamentals of building science and the energy efficiency industry, or becoming a certified Energy Auditor, this series of online courses is for you. Every other week starting in March 2010, our online series will support you in becoming a building performance professional from the comfort of your home or office. Each interactive course is presented in real-time by our building science experts,  more...

Multifamily Building Modeling for Weatherization Get on the fast track for multifamily weatherization work with an introduction to energy modeling for multifamily buildings. This 2-hour interactive webinar will include the basics of multifamily energy modeling using DOE weatherization approved audit tools. It will include a systematic approach to improvement-driven modeling in multifamily buildings - with plenty of opportunity to get all your  more...

Introduction to Professional Organizing - Webinar ...it takes to enter and succeed in this dynamic 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  more...