GlobalCompliancepanel

Shahanshah Manzoor

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place. GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them: Risk Management Regulatory Compliances Corporate Governance Quality Management

Offerings

Showing 1-25 of 1407 results
  • COURSES: FDA Regulations for instrument Qualification and Validation Processes

    Overview: In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Why Should You Attend: The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility?
  • COURSES: Regulatory Compliance by Implementing the Cost Effectively

    Overview: This webinar will introduce and overview the concept of containing compliance costs - working smart. The webinar will provide a comprehensive strategy for cost reduction in regulatory affairs and compliance by presenting strategies for complying with FDA regulations in a cost-effective manner. Why should you Attend: What is the result or impact of the regulatory environment on the business? Companies find themselves in the position of doing too little or too much relative to compliance because they are simply not sure. Too little in terms of compliance makes you vulnerable to the FDA's auditing/checking function opening your company to a varying array of sanctions that could significantly impact your business.
  • COURSES: Goldratt's Theory of Constraints

    Overview: This applied to his logistics system, which another reference depicted as a "continent spanning conveyor," but continuous flow in his factories achieved the same purpose at the manufacturing level. This, and the relatively low inventories carried in the chemical process industries, shows that it is quite possible to go beyond the Theory of Constraints by looking for ways to eliminate variation in processing and material transfer times. Why should you Attend: No manufacturing process can work faster than its slowest operation, the constraint or capacity-constraining resource. This carries over into project management where no project can finish more rapidly than the events on its critical path.
  • COURSES: Project Management Business Administration

    Overview: This course begins with general principles of Project Management Business Administration (PMBA) and continues to elaborate on specific topics relevant to pre-bid scenarios, execution phase strategies, and close out dilemmas. Why should you Attend: Do you know how many successful projects it takes to cover the loss from one bad project? Do you understand the stress on a company when a project does not have positive cash flow? Do you want to be sure that when layoffs come around, that you are kept on board?
  • COURSES: Differences between ISO 13485 2015 versus ISO 13485 2003

    Overview: The webinar will first present the key differences between ISO 13485 2015 versus ISO 13485 2003.Next, the speaker will provide an overview of the updated standard. Why should you Attend: This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.
  • COURSES: Analytical Method Validation in FDA process

    Overview: An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle. Why should you Attend: Observations that test methods are inadequate or the firm does not have appropriate data that demonstrates the method performs as intended rank high on the list of observations in the laboratory.
  • COURSES: Understanding the USP 1058 Analytical Instrument Qualification

    Overview: 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. Areas Covered in the Session: FDA and EU analytical instrument requirements Most common inspection problems Recommendations for firmware and software validation Roles and responsibilities: QA, manufacturer, user Qualification of existing systems
  • COURSES: Statistical Analysis of Measurement Uncertainty : Metrology

    Overview: The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". The webinar ends with an explanation of how to combine all relevant uncertainty information into an "Uncertainty Budget" that helps determine the appropriate width of QC specification intervals. Why should you Attend: All manufacturing and development companies perform testing and/or inspection that involves measurements of products, components, and/or raw materials. The output of those measurements is compared to design or QC specifications, to determine whether or not the measurements "pass" those specifications.
  • COURSES: Packaging and Labelling for Clinical Products

    Overview: The program will review how to establish an effective artwork change management and approval system, including real-life examples of system successes and potential pitfalls. Why should you Attend: Program will discuss practical development of packaging design and optimizing the design to fit the intended purpose. You will learn to translate a protocol into optimal package design.
  • COURSES: Effective FDA and ISO Management Reviews

    Overview: In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system efficient and effective. Why should you Attend: Are your management reviews effective or do you have trouble getting senior management engaged? Perhaps you are not using an effective approach that fits your company or your management.
  • COURSES: How to Conduct a Human Factors - Test following ISO 62366q

    Overview: This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Why should you Attend: We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. The post test participant inquiry is critical to validation success. we will describe how to do this.
  • COURSES: Design Inputs Design Outputs Traceability Matrix

    Overview: If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work. Areas Covered in the Session: Brief introduction to Lean Documents and Lean Configuration. Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents. Traceability Matrix. Applying lean document and lean configuration principles to the above. Bringing it all together
  • COURSES: 1099-MISC:Block By Block Discussion

    Overview: This course will cover not only these common mistakes but make suggestions regarding the contents of each Block on the Form 1099-MISC. Why should you Attend: Form 1099-MISC is one of the most common Information Reporting Form that businesses, estates, trusts and non-profits are required to file at the end of the calendar year. It is also the Form 1099 that most commonly has errors identified by the IRS.
  • COURSES: Client Expectations Without Losing Your Shirt or the Next Job

    Overview: By learning to present issues in the right framework we decrease adversarial behaviors on the project and increase the likelihood that our proposals for additional work will be accepted. Why should you Attend: Our attitudes are the most important tool in our toolbox. It costs us nothing to purchase, if we use it well it can gain us everything, and if we use it poorly it can cost us everything. How we use it is up to us. Participants will learn how to get the most from their project team by focusing on key attitude changes.
  • COURSES: Acceptance Sampling by Variable inspections

    Overview: This presentation covers the methods in Z1.9 and shows how to use most common choice, standard deviation unknown. The presentation explains how a simple statistical calculator easily provides the needed sampling statistics. Why should you Attend: If you are responsible for any acceptance activities, such as incoming inspection, you need to evaluate them for cost reduction opportunities. One viable alternative, Z1.9, applies when the inspector measures actual values and converts them to pass/fail to use Z1.4 or c=0. The sample sizes may be too large. This presentation will help you understand Z1.9 and determine if it a better choice.
  • COURSES: Preparation for GMP Inspections by Regulatory Agencies

    Overview: This webinar will provide practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible, including ongoing readiness for inspections, rehearsals and preparation for successful facility inspections, and response to findings by regulatory agencies. Why should you Attend: Good manufacturing practice (GMP) is the minimum standard that a manufacturer must meet in their production processes. This webinar will review what to expect during the Agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.
  • COURSES: How to improve the quality of their products by Statistical Process Control

    Overview: This webinar will be focusing on statistical process control as companies want to improve the quality of their products and to improve product quality need to be structured in such a way that they have a reasonable chance of success. Why should you attend: All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The most successful method available for such endeavors is called SPC (statistical process control).
  • COURSES: Biologics Facility Design & Pharmaceutical Regulatory Aspects

    Overview: This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them. Why should you Attend: The attendee will learn what is important in facility design from the FDA and regulatory standpoint. The attendee will understand what FDA looks for during a facility inspection. The attendee will be able to minimize possible design errors which are difficult and expensive to fix post-build. The attendee will understand what FDA looks for in reviewing the facility design and the flow patterns.
  • COURSES: What to Do When It's Not a Bell Curve?

    Overview: Statistical textbooks, manuals, and even most software rely on the assumption that processes conform to the normal or bell curve distribution. Why should you Attend: Almost all traditional industrial statistical methods rely on the assumption that the critical to quality (CTQ) characteristic follows the normal or bell curve distribution. The bell curve is far more common in textbooks than it is in real factories, where processes often follow other distributions.
  • COURSES: FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11

    We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News Overview and Key Requirements of Part 11 & Annex 11 How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
  • COURSES: Seminar on 21 CFR Part 11 compliance for software validation and SaaS/Cloud

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
  • COURSES: The New Clinical Trials Regulation and Regulatory Affairs Aspects 2017

    The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Scientific advice is a vital element in the development of a medicinal product, and knowledge of the how to choose between national and EU scientific advice, as well as the preparation and procedure is vital for a successful outcome Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900936SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • COURSES: FDA Data Integrity for Computerized Systems 2017 | 21 CFR 11

    The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News Overview and Key Requirements of Part 11 & Annex 11 How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900944SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • COURSES: Seminar on Product Information for Medicinal Products in the EU 2017

    Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment.
  • COURSES: Seminar on FDA Data Integrity for Computerized Systems in Mumbai

    The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following? • Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News • Overview and Key Requirements of Part 11 & Annex 11 • How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? • How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity, it is often very hard to apply requirements for DATA INTEGRITY to computerized system, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements.

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