Demonstrate Web-based Seminars

Learn to design and build websites with Adobe Dreamweaver at UCSD Extension Digital Arts Center Learn to design and build websites using Adobe Dreamweaver, a powerful and easy-to-use web page development software. Gain a familiarity with basic HTML and CSS to design websites within Dreamweaver's rich web authoring environment. Participants will use Dreamweaver to work with text, photos, graphics, and tables, and customize pages using CSS. Students will build at least two websites and  more...

The Most Important Metrics For Measuring Supply Chain Performance ...inar leader will explain each of these common metrics and demonstrate how each is calculated. Participants will be encouraged to share their ideas and views in this fully interactive LIVE web conference format. Participants should be prepared to openly discuss their ideas and to interactively comment on other participanta ™s ideas presented during this LIVE webinar. This program should  more...

Integrative Activity Based Costing Leadership An Overview of Bottom Up Cost Accounting ...mprovement 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 allocations based on activities instead of labor  more...

Supervision in Clinical Traumatology ...demonstrate proficiency in clinical traumatology skills. The program is offered in a format designed to challenge and help participants grow into competent providers of care for traumatized individuals, families, organizations and communities. *Participants must complete courses TI-1001 & TI-202 to TI-207 in order to enrol in this course. OBJECTIVES: Supervision in Clinical Traumatology  more...

Demystifying the Calculations of Efficiency Utilization and Productivity ... This 1-hour FREE webinar will address these three terms, demonstrate how to calculate each and describe where they are used in a manufacturing enterprise. With the demonstration of the formulas, we will explain how values derived from the formulas can be altered and how companies can benefit from the CORRECT understand of these terms. We will clearly show participants HOW to calculate these  more...

FDA Inspections - Dos Donts - Webinar By GlobalCompliancePanel Overview: The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that your products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful inspection is being prepared to communicate how your quality systems assure this state of  more...

How to submit a 510k and get it cleared from FDA - Webinar By GlobalCompliancePanel Overview: This webinar is intended to demonstrate how submit a 510(k) and get it successfully cleared from the FDA. Thursday, June 28, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Bullet Proof 510k Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Tuesday, June 26, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

New Process Validation Life-Cycle Approach - Apply statistical tools to demonstrate Process Capability - Webinar By GlobalCompli This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process Qualification and the Continued Process Verification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Bullet Proof 510k - Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Thursday, November 17, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Designing Drafting Writing and Implementing The Quality Manual ...unctions to reach their goals and objectives. It will demonstrate that the quality manual represents system for working together to achieve the organization's goals. You'll be shown that a quality system exceeds compliance requirements without question. As mentioned above, it can be viewed as a "Organizational Constitution" that empowers people to "pass laws" (SOPS) for working together. It  more...

FDA Inspections - Dos Donts - webinars by gcp The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  more...

FDA Inspections - Dos Donts The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  more...

Understanding and Implementing USP 1058 Analytical Instrument Qualification - Webinar By GlobalCompliancePanel ...demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for analytical methods there are no clear  more...

What to Expect and How to Prepare for FDA Inspections - GlobalCompliancePanel ...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 investigations and  more...

Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors - Webinar By GlobalCompliancePanel ...demonstrate how to implement an effective audit program. Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the firm's responsibility to make sure vendors/ suppliers are meeting specifications for the supplied materials,  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ... Identify non-compliant documentation practices Demonstrate how to attach raw data to forms and lab notebooks Explore what FDA investigators actually look for during a lab inspection Areas Covered in the Session: 21CFR and Eudralex references to documentation Correcting errors and omissions Dates and formats Meanings of initials and signatures Use of  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...inevitable FDA inspection, or a vendor wishing to clearly demonstrate a software product is Part 11 compliant, this teleconference will give both old hands and new staff the practical information needed to understand the applicable regulations and solid methods to document compliance. * FDA inspectors are now being trained to evaluate software validation practices. * Increasing use of  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...atory equipment should be calibrated and/ or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...nar, we will review the Good Documentation Practices plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena. Why you should attend: The Learning Objectives of this presentation include: * Discover what the regulations say about documentation practices * Learn what your signature and/ or initials mean on a document * See  more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel ...n a meaningful validation program in order to effectively demonstrate that the new RMM is suitable for its intended use and is equivalent to, or better than, the existing method you intend to replace. Topics will include the development of User Requirements Specifications, the validation master plan, IQ, OQ and PQ expectations, and a comprehensive review of how to utilize USP Chapter 1223, Ph.  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ...window of time during which the NDA/ BLA/ ANDA holder can demonstrate to the FDA that the quality systems at the site are in compliance with the GMPs and that appropriate facilities are available to support manufacture of the product. It is therefore important to present the organization in the best light possible. Areas Covered In the Seminar: * Pre-Approval Inspections *  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ... Regulatory agencies expect manufacturers to periodically demonstrate that cleanrooms and controlled environments perform according to their design specifications. In addition, periodic testing confirms the efficacy of maintenance and process controls. It is the responsibility of the Cleanroom owner to maximize the value of cleanroom testing to ensure optimal performance. Many Cleanroom  more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel ...rd 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 to manage and archive raw data and other electronic records * Data migration to new systems * Developing a procedure for consistent raw data  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods  more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel 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, employees recognize and must follow Good Documentation Practices (GDP). These practices apply to all pharmaceutical  more...

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel Excel Applications are widely used in laboratories, offices and manufacturing e. g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for  more...

Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - Webinar by GlobalCompl This interactive one-day seminar details how to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. Nearly every computerized system used in laboratory, clinical, manufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software  more...

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel ...the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control. However, the arrival of  more...

Signal Detection and Data Mining - Webinar by GlobalCompliancePanel This webinar will cover the fundamentals of signal detection, and how these can be augmented by the use of data mining techniques. In March 2005, the FDA published final guidance on "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment." This guidance defines the FDA's views on pharmacovigilance concepts, safety signal identification, pharmacoepidemiologic assessment and  more...