Auditors Web-based Seminars

Management Styles that Work Best for Each of the Four Generations in the Workplace - Webinar By TrainHR This session is designed to help you manage more effectively by being able to differentiate between each generation and adapt to their style and outlook and capitalize on their strengths  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...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel ...sis 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 effect of the other elements. As a result, potential complimentary synergies between control elements have typically been overlooked while gaping compliance  more...

Calibration Concepts for Auditors and Reviewers - Webinar By GlobalCompliancePanel This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option.  more...

Chromatography Peak Integration for Operators Auditors and Reviewers -Webinar By GlobalCompliancePanel Integration of chromatographic peaks is a critical step in the generation of chromatographic data. Errors in integration will result in a corresponding error in calculated results.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...versions to make and implement cGMP decisions. Regulatory auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the dangers of neglecting thorough, and risk based Part 11 software verification and validation activities. Simple but effective and real world 21 CFR Part 11 software V&V is even more important in todaya ™s resource  more...

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

Document Retention and Destruction You should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in  more...

Document Retention and Destruction by TrainHR You should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in  more...

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

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel Overview: 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. 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  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel Overview: The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP" and a definition that is  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...ication of software is relatively defect-free. Regulatory auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the dangers of neglecting thorough, and risk based software verification and validation activities. Effective and real world software V&V is even more important in todaya ™s resource constrained industrial environment.  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel Overview: 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. Why Should You Attend: More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using  more...

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

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

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP Overview: The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on identifying cleanroom garment systems, how they should be used, management of their supply, and control of human variables. Key benefits of this seminar include: * In-dept understanding of cleanroom garments and their use. * Reduce personnel-related environmental contamination issues. * Achieve satisfactory inspections more easily.  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...eaning 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 to control cleanroom cleaning processes and ensure best practices are followed. Areas Covered in the Session: * Learn about  more...

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

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 Overview: 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. 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  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...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel Overview: This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option. Whether you use single point calibration, or linear regression, we will discuss the strengths and  more...

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

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel Overview: Virtually all field inspections performed by FDA inspectors are done according to the QSIT. It is thus imperative that all regulated companies have an in-depth knowledge of this system, to enable them to prepare for the inspection. Delving into each and every section of the QSIT, this webinar also includes straightforward, helpful methods for incorporating it into your companya  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel Overview: This webinar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. The seminar begins with Excel methods to help ensure the spreadsheet produces the results  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...sis 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 effect of the other elements. As a result, potential complimentary synergies between control elements have typically been overlooked while gaping compliance  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel Overview: Where business is concerned the world is becoming a smaller place. Trade boundaries are disappearing, and many companies have subsidiaries around the world. Multi-national corporations needed a simpler way to put together their consolidated financial statements. Already Australia, most of Europe, and many other countries have adopted International Financial Reporting Standards.  more...

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

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...ll these topics and provides you with plenty HOW TO we as auditors and inspectors increase our comfort level with the regulation, with its elements and compliance and practically implement audit system and audit trails - especially since Audit Trails play major role in Part 11 compliance - they can be your best friends and/ or worst enemies at the same time. Areas Covered in the Seminar:  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ..., and Timelines? Use the Plan as a powerful tool with FDA auditors. Use variations on these tools for any project, from the smallest to major company projects. Growing high-profile field problems indicate that much project management is poor or non-existent. Buy up-front time for proper project planning. These techniques are not rocket-science, but require the implementation of formal methods  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel ...t. This session will allow your team to anticipate the auditors needs and result in the facility's ability to achieve the maximum benefit and score from the audit. Why you should attend: More and more customers are requiring GFSI audits such as ISO 22000, BRC and SQF or accepting them in lieu of their own audits. Without passing scores on these audits, companies are losing current  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel ...ile regulatory and audit guidelines can be vague at best, auditors have increased their vigilance in this area due to the recent focus on biosecurity and food safety. Learn and teach your team to implement a world class program that will protect your organization and exceed your customers expectations. Areas Covered in the Session: * What types of materials are to be considered *  more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel Overview: This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA's concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates that CAPA systems  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes,  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information  more...

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

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel Overview: In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows  more...

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

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane Overview: This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result  more...

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

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

Introduction to Operational Risk - Webinar By GlobalCompliancePanel Overview: This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials  more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel ... so that it is readily available for review (by managers, auditors or inspectors), when to evaluate training requirements, training effectiveness, and when training is not required. Why Should You Attend: On of the easiest ways to be cited for a major noncompliance during an ISO audit is to have an insufficient training system. Similarly, an FDA inspector will head right to your training  more...

Value-Adding Internal Auditing Learn how to get your Internal Audit System to promote improvements and add real value to your or ... 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 knowledgeable fashion using a wide variety of hands-on activities and teaching methods. This  more...

Developing an Effective Supplier and Internal Auditing System - Webinar by GlobalCompliancePanel The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day. Are there going to be noncompliance? You bet. Are you going to correct these noncompliances? Only if you identify them. To ensure substantial compliance, your company needs an effective audit program for both internal and external processes. To have an effective audit  more...

ITIL Foundation Bridge Virtual Classroom Take the ITIL ® v3 Foundation Bridge course Virtual Classroom is set up in the same manner as the physical classroom however altered to optimize the virtual learning experience without the hassle of travel. The virtual classroom delivery option is ideal for training geographically dispersed teams. This 2-day course introduces learners to the lifecycle of managing IT services to deliver to  more...

ITIL v3 Foundation Virtual Classroom Take the ITIL ® v3 Foundation course Virtual Classroom is set up in the same manner as the physical classroom however altered to optimize the virtual learning experience without the hassle of travel. The virtual classroom delivery option is ideal for training geographically dispersed teams. This exciting and dynamic 3-day course introduces learners to the lifecycle of managing IT services  more...