Equipment Web-based Seminars

Grow Spiritually Succeed Managerially Thinking is an art, a skill and one needs to practice it like a musical instrument or a sport. A successful manager or a leader must learn how to use this wondrous equipment in order to think, to reason and decide his / her course of action(s) in personal as well as professional life. Learning Objectives: History of human development, Intellect Vs Intelligence, Objectivity at work, 3 C's of  more...

Java EE Seminar for Managers ...th no hands-on exercises for students and no need for lab equipment. The instructor demonstrates several sample Java EE applications, including web applications, EJBs, JMS, and web services, and can go into source code and other details to suit the interests of the audience. But the focus is on architecture, and on boiling down a very complex system to its essential features: code  more...

Should Under-Utilized Capacity Costs Be Included in Work Center Burden Rates ...factory UNDER-UTILIZATION increases? Plant, property, equipment and people do not go away just because utilization drops. And yet, as utilization drops, gross margins also drop, which may suggest a product PRICE increase is in order except if prices are increased, wona ™t demand drop even further thereby reducing gross margins further in a seemingly endless downward spiral? This is  more...

A Better Method for Rationalizing Capital investmentsTools for Calculating REAL Investment Value ...th the best way to rationalize new investments in capital equipment. Interestingly enough, this struggle is often the result of failed cost accounting systems and methods. It is these systems that fail to provide accurate information that ultimately allow an investment to be appropriately modeled within the context of the entire organization. We will present a perspective and the  more...

How to Calculate the Impact on Total Factory Costs from a One Percent Change in Planned Load ...he aggregated expenditures on plant, property, people and equipment (PPP&E). For manufacturing companies to grow and sustain success, knowledge of what a 1% change in volume does to utilization and incremental fixed costs is essential. This 1-hour FREE webinar will present some interesting thoughts and techniques, specifically focusing on how your company can come to an understanding of  more...

Key Steps for Risk Assessment - Webinar By GlobalCompliancePanel The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as  more...

Change Control Management From Design to Commercialization - Webinar By GlobalCompliancePanel There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/ systems specifications in addition to the more formal change control after the qualification of these systems. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Wednesday, December 14, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Does your Equipment Program Meet Current Regulatory Expectation - Webinar By GlobalCompliancePanel This Interactive webinar will begin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Thursday, October 20, 2011  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar By GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Master Validation Planning - Webinar By GlobalCompliancePanel A Validation Master Plan (VMP) is a critical part of a successful validation project. It documents the intended path to be taken for the validation of an entire organization, one or multiple plants, a single system or assembly line, or even a collection of similar equipment, to be qualified and eventually validated.  more...

Requirements of validation and control of EO Sterilization - Webinar by global compliance panel Sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies.  more...

Practical Laboratory Statistics ...are data sets generated from many different kinds of test equipment. Why Should You Attend: Most people hate statistics, because they don't understand statistics. If you either generate or review laboratory data, you will want to attend this seminar. We will discuss the basics in a way that doesn't involve lots of jargon and complicated equations. We use real world examples and common  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...ce. We will define how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness. Why should you attend: Radiation sterilization validation is a topic that results in many audit  more...

Creation and configuration of a Equipment Facilities and Preventive Maintenance System utilizing the principles of Lean Document Proper preventive maintenance and management of process equipment, and facilities is the foundation for any manufacturing process, including many processes not typically thought of as manufacturing.  more...

Understanding and Implementing USP 1058 Analytical Instrument Qualification - Webinar By GlobalCompliancePanel Analytical instruments should be qualified to 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  more...

Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors - Webinar By GlobalCompliancePanel This webinar will 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  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...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...ct and Process Design * Similarities and Differences-Equipment and Facilities * Similarities and Differences-Supplier and Component Consistency * Protocol Approval Process for Installation & Operational Qualification and Process Validation * Executing the Protocols * Reviewing the Issue Protocols, Taking Appropriate Actions, and Writing the Report * Revalidation  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...s-Product * In-Product * In Production and Test Equipment and * The Quality System A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process. Why Should You Attend: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...ions. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered.  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...e. * Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. * A third of recent warning letters included citations with respect to improper or ineffective validation. * Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. This presentation will review the validation  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...trates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies. It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are: * In-dept understanding of cleanroom cleaning methods. *  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...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 a  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...9 - Comparing Master Records * Module 10 - Comparing Equipment Controls * Module 11 - Comparing Material and Incoming Controls * Module 12 - Comparing the Control of Processes * Module 12 - Packaging and Labeling Comparisons * Module 13 - Laboratory Controls and Device Evaluation * Module 14 - Holding, Distribution, & Returns * Module 15 - Problem  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...ain adequate validation documentation systems and perform equipment qualifications and process validations, and evaluate the need for re-validations. Why you should attend: The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with process validation. Regulators believe through careful design and  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel ...egin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Why you should attend: The equipment Program is a  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ... + Validation of off-the-shelf software and automated equipment * Electronic records o General requirements for records o Definitions from Part 11 + Electronic records + Closed systems + Open systems o Summary of requirements + Validation + System access  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...red In the Seminar: * Define cleanroom filters and equipment * Identify regulatory expectations and industry standards * Define the tests, frequencies, and methods * Define the expectations for testing equipment * Identify who does the testing * Identify requirements for documentation/ logs/ labeling * Define criteria and how to interpret results Who will  more...

Practical Laboratory Statistics - Webinar by GlobalCompliancePanel ...are data sets generated from many different kinds of test equipment. Why Should You Attend: Most people hate statistics, because they don't understand statistics. If you either generate or review laboratory data, you will want to attend this seminar. We will discuss the basics in a way that doesn't involve lots of jargon and complicated equations. We use real world examples and common  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...pps V&V Requirements * Problem Areas * Product, Equipment/ Process, QMS and Apps Software and Part 11 Requirements * Realistic Limits of Apps Software V&V * Suggested Approaches * How to Implement, Execute and Document * Proper Risk Allocation of Scarce Resources Who Will Benefit: * Senior management in Drugs, Devices, Biologics, Dietary Supplements  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel ... safety chain. Lack of control of parts and condition of equipment often contributes foreign material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as customer order fulfillment. A systematic approach to maintenance is critical to operations, quality and safety. Areas Covered in the Session: * How to prepare an audit policy and  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that cover each environment and present  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ... Records Module 4: Design Control Module 5: Facilities, Equipment & Environment Module 6: Material a Purchasing Controls-Specification, Qualification and Control of Suppliers, and controlling incoming materials Module 7: Technical and "Administrative" Process Controls Module 8: Introduction to Deviations & Quality Failures (0: 10) Module 9: Validation Module 10: Maintaining Label  more...

Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel ... safety chain. Lack of control of parts and condition of equipment often contributes foreign material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as customer order fulfillment. A systematic approach to maintenance is critical to operations, quality and safety. Areas Covered in the Session: * Preventive Maintenance *  more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel ... system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement. The presentation states with the regulatory requirements in the FDAa ™s QSR, ISO 13485, and ISO 9001. After analysis of these requirements, the presentation examines available guidance documents. The FDA  more...

Process Instrumentation and Control Online Certificate Course ... basic concepts, engineering, and installation of control equipment. The attendees will learn about: 1. Basics of I&C, including different control functions, types of control loops, and continuous vs. discrete control. 2. Identification and symbols used in I&C. 3. Different types of field instrumentation, their principles of operation, their advantages and disadvantages and the  more...