Trainings Web-based Seminars

HIPAA and Security Breaches Most frequent issues and causes and trends for future threats by GCP The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations  more...

Good Deviation Practice what you need to know-BY GCP This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/ CAPA system and thorough investigations  more...

Device Master Record Device History Record BY GCP The FDA's Quality System Regulation (QSR) requires each device manufacturer to compile the specifications and procedures for a medical device.  more...

Preventing Food Safety Problems BY GCP Most industries have become reasonably sophisticated in terms of applying the principals and tools involved in quality control and improvement.  more...

This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape.  more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements by GCP Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices  more...

Surviving a DEA Inspection by a Hospice Program BY GCP The Drug Enforcement Administration (DEA) has been focusing on the prescribing of Schedules II narcotic substances by practitioners caring for their patients in a certified Hospice Program where narcotic drugs are prescribed for the individual patient.  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to market in the EU as well  more...

ISO 13485 for Medical Device QMS by GCP This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485.  more...

FDAs final Medical Device Data System Rule FDA's promulgation of Electronic Medical Records, introduction of Meaningful Use and desire to automatically acquire medical device data for inclusion in electronic records has resulted in the development of Medical Device Data Systems.  more...

Pharmaceutical and Biologics Facility Design FDA and Regulatory Aspects by gcp This course explores some of the best practices of pharmaceutical facility design with an emphasis on the regulatory aspect.  more...

Lyophilization What you Need to Know Validation and Regulatory Approaches by gcp This course explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization.  more...

Excel Spreadsheet Validation to Eliminate 483s by gcp This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits This webinar details both regulations and provides details for implementing computerized systems  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...

Master Production Record Requirements - Webinar By GlobalCompliancePanel This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding 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  more...

Adverse Event Reporting for Dietary Supplements and OTC Drugs - Webinar By GlobalCompliancePanel Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs. Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will be able to  more...

The Risk to Subject Safety of Not Accurately Reporting Adverse Events - How to Assess and report AEs and SAEs - Webinar By Globa 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.  more...

Introduction to Risk Management - 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 of Risk  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...

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...

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...

How to Survive a DEA Audit - Webinar By GlobalCompliancePanel this training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals.  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...

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

Analytical Test Methods Validation for GxP Laboratory Compliance FDA ICH and USP Requirements - Webinar By GlobalCompliancePanel This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation  more...

Risk-Based Validation for GxP Facilities - Webinar By GlobalCompliancePanel This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan  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 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...

WorkPlace Skills A set of skills that are essential to success in the work life. These are very basic and fundamental skills one should possess to be successful in job selection or to succeed in his/ her work atmosphere. 1. Email and Telephone etiquette 2. Using MS Excel 2007 / 2010 3. Using MS Word 2007 / 2010 4. Using MS PowerPoint 2007 / 2010 5. Using emails - Webmails, Outlook etc., 6.  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection GlobalCompliancePanel brings a new webinar on the topic of 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection. Webinar will be on March 4, 2010. Webinar will be presented by Jasmin NUHIC. Mr. NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive  more...

FDA Compliant HPLC Qualification and Performance Testing GlobalCompliancePanel brings a new webinar on the topic of FDA Compliant HPLC Qualification and Performance Testing. Webinar will be on March 4, 2010. Webinar will be presented by Dr. Ludwig Huber. Mr. Huber is Director of Lab compliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Lab compliance, the global on-line resource for validation and  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...

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...

Oracle Financial R12 Oracle Supply Chain R12 SOA 11g Training ...in Training: Demo on March 13 at 10: 00 AM PST Mode of trainings: Our trainings are conducted in class and we share the class online to the Participants who are unable to attend in class training using interactive web-conferencing software which also has integrated VoIP. Participants will be able to view trainer's desktop remotely & communicate with him at the same time as done in class.  more...

Oracle Financial R12 OBIEE 11g SOA 11g Training ...g : Demo on March 13 2011 Mode of trainings : Our trainings are conducted in class and we share the class online to the Participants who are unable to attend in class training using interactive web-conferencing software which also has integrated VoIP. Participants will be able to view trainer's desktop remotely & communicate with him at the same time as done in class.  more...

Siebel CRM Training - Online SiebelTraining. org provides the facility of online trainings via web/ video conference, especially for its trainees in US, UK, Australia, Canada, Europe, Middle East, Singapore, Malaysia and China. All the courses offered by us in classroom sessions are also offered via the online platform but with more emphasis on quality given the one-to-one interactions.  more...