Cause Web-based Seminars

MANAGING LEAVE OF ABSENCE PART I - FMLA FMLA is one of the most complicated and legalistic laws out there. It is also one of the most important laws that you need to know about when managing an employee's leave of absence issues. Make sure that your managers and HR Managers understand how to ensure legal compliance with the FMLA. This webinar will provide our top tips for avoiding the FMLA mistakes that can cause legal liablity and  more...

SUBSTANCE ABUSE AND THE ADA WHAT YOUR MANAGERS NEED TO KNOW ...e drug users in the workplace can impact productivity and cause attendance and absenteeism problems in addition to performance issues. Find out whether these workers are protected by the ADA and what your supervisors should do to manage substance abuse issues that occur. Recovering Alcoholics and Drug Addicts also can cause issues. Find out how each of these is treated by the ADA and get best  more...

Introduction to EJB 3.0 This course introduces the experienced Java developer to Enterprise JavaBeans -- the Java EE standard for scalable, secure, and transactional Java components. EJB 3.0 has reinvigorated this area of Java enterprise development, with dramatic improvements in ease of use and smooth integration with servlet-based or JSF web applications. This course treats the 3.0 specification, with a few notes on  more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing ...ting failures and methodically determining the underlying cause(s) before the predicted failures can manifest into real failures. SPC represents a progressive set of predicted and predictive technical tools that any individual can use to diagnose probable causes of predicted process failures and then systematically determine alternative solutions. Most manufacturing company executives,  more...

Better Methods To Control Tools Fixtures in Production ...ial availability, it is often the tools and fixtures that cause manufacturing disruptions, sometimes leading to shipping delays and customer dissatisfaction. How many times have you been ready to produce, only to discover the tool was missing or non-usable? In this 1-hour FREE webinar, we will explore some specific techniques for better managing the quality and availability of tools and  more...

Understanding Improving Yields Scrap Rework ... comingled in the measurement procedures, underlying root cause analysis is certain to result. This FREE 1-hour webinar presents the CORRECT definitions of yield, scrap and rework. The proper use of these terms as well as how each is calculated and monitored will be demonstrated. Specifically, we will address: - How to PROPERLY measure yieldsa why is a yielda different from scrap?  more...

Integrative Activity Based Costing Leadership An Overview of Bottom Up Cost Accounting This powerful 1-hour FREE 3rd Thursday - a Operations Improvement webinar has 3 important objectives: 1. To demonstrate how a bottom-up version of ABCA can be used to better allocate support costs. With some commonly 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  more...

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration - Webinar By GlobalComp Overview: Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors,  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - GlobalCompliancePanel Overview: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. Tuesday, June 19, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

RAPS Approved Seminar on The A to Zs of Microbial Control Monitoring and Validation of Pharmaceutical Water Systems ...cation or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance,  more...

RAPS Approved Seminar on Microbial Control Monitoring and Validation of Pharmaceutical Water Systems at Mumbai ...cation or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance,  more...

RAPS Approved Seminar on The A to Zs of Microbial Control Monitoring and Validation of Pharmaceutical Water Systems at Mumbai ...cation or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance,  more...

Root Cause Analysis and Documentation Requirements for CAPA - Webinar GlobalCompliancePanel Overview: RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. Tuesday, April 17, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar GlobalCompliancePanel Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. Thursday, February 2, 2012 10: 00 AM PST | 01: 00 PM EST  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...

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

Hazard Analysis A practical guide - Webinar GlobalCompliancePanel Hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time. Tuesday, December 6, 2011 10: 00 AM  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviation - Webinar By GlobalCompliancePanel Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. Thursday, December 8, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Hazard Analysis A practical guide - Webinar By GlobalCompliancePanel If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time. Thursday,  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...

How to Conduct an Offensive Behavior Investigation by TrainHR ...ation investigations. Learn how flawed investigations can cause nightmares for employers. Understand when you need to call in a professional to conduct your investigation. Receive updates on the most recent cases on these issues and learn what the courts require with regard to a prompt thorough investigation. Become familiar with what your goals should be in the investigation and what the risks  more...

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

How to Create Configure and Manage a Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documen ...ndustries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while presenting a fresh new approach to these key and related documents. Why you should attend:  more...

Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean ...often, controlled documents 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 the corresponding Theory of Lean Configuration to this key part of a QMS. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in  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...

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...

Developing an Effective CAPA Strategy through Root Cause Analysis of Failures Deviations - Webinar By GlobalCompliancePanel Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This webinar highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ... well, especially now that portable devices are a leading cause of information security breaches. If you are asked by the US Department of Health and Human Services to show that you are in compliance with the HIPAA security regulation, you will need to show that you have the proper policies and procedures in place as required by the rules and that you have been using them. This  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...Cause Analysis (RCA) is a major tool in 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  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ... regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/ or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ... * The differences in the OC curves and why they can cause problems * How a change from Z1. 4 to c=0 can impact your inventory and disrupt your suppliers Why should you attend: Imagine this! Your company uses acceptance sampling in your manufacturing process and your manager asked to make sure it is cost effective. She also knows there is some risk associated with sampling, but she  more...

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

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel ... in the past identified OOS Investigations as the leading cause for concern in Pharmaceutical laboratories. A review of the Warning Letters issued in the past year shows that OOS Investigations continues to be among the most frequently cited area. The Investigation system will therefore continue to receive close scrutiny during FDA inspections in the coming months and years. The large number of  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...nar will provide a recent update on the latest trends and causes for device recalls and emerging trends. Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...cessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a "living document". Areas Covered in the Session: * The Revised ISO 14971: 2007 for Devices * ICH Q9 for Pharma * Product Hazard Analysis * Design, Process, and Use[r] Failure Mode, Effects and Criticality  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...s and systems. Change can be beneficial, but is often the cause of new and even worse problems than those the change was designed to eliminate. It can be the root cause of a major problem, cGMP "entropy". Proper change control is required to resolve any underlying compliance issues or product problems that are increasingly seen by regulatory agencies and consumers worldwide. To meet this new  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...professional. Process validation can be difficult and can cause confusion due to different standards, approaches, and process complexities. In this webinar, the basics 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  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...ools, which are great for identification of the true root cause(s) of the issue o These tools also used for corrective actions, for most optimal definition of the improvement, for preventive actions o Visual representation of the tools and examples where and when to use them o Importance of proper assignment of a CAPA o Examples are provided when it  more...

Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel ...erility. Failure to prove sterility in almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. If intended to be resterilized by the user facility, cleaning & sterilization instructions must be precise and validated. Areas Covered in the Session: * Reasoning behind labeling requirements *  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...l) 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 done properly. Areas Covered in the Session: * Review of GMP regulatory expectations of training (FDA and EU) * Recent training-related citations *  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...d corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses adequate investigation of deviations. Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. The  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ... suppliers represent high risk? Which ones are likely to cause an outbreak associated with E. coli or salmonella? Should your company buy from high risk suppliers? How do you know which suppliers are high risk suppliers? These are the types of concerns wholesalers have about farm suppliers, retailers have about wholesalers and processors have about both. Where do buyers go to determine the  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...the penalty levels include new definitions for reasonable cause and reasonable diligence, as well as willful neglect, which have a direct impact on the amount of penalty a violation may be subject to. Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information - the electronic age in health care brings new obligations  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ... of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry. Reference material for easy implementation: * 25 recent FDA Warning Letters with part 11 violations. * 15 Case Studies: Implementing  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel ... 483 laboratory operation based observations, analyze the cause and propose measures to prevent similar observation on other laboratories. Areas Covered in the Session: * Regulations * Inspectional Guidances * Laboratory controls * Specification, standards, sampling plans, test procedures * Conformance to specifications * Complete data * OOS *  more...

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

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel ...t there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must  more...

Manufacturing Optimization Online Certificate Program ...nsists 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 program includes basic concepts, improvement opportunity identification techniques, implementation strategies, risk identification and avoidance  more...