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 3517 results
  • COURSES: Using VLOOKUP, MATCH, and INDEX

    This webinar on how to use VLOOKUP, MATCH and INDEX, which will help you tremendously. In this webinar you will learn about VLOOKUP function in Excel, which enables you to quickly and easily look for a value down a column of data and return a value from the same row in a different column.
  • COURSES: FDA Requirements for Design Inputs and Outputs

    This webinar will walk you through step-by-step how to complete a DIOM for your product and simplify this often overly complex process, This webinar provides a simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both.
  • COURSES: Early Completion Schedules - Benefits, Risks & Defenses

    Overview A contractor's right to complete work early was acknowledged by U.S. Courts in the 1940's. As a result, delayed early completion claims became much more common in the 1960's. It was then, and remains now, a controversial issue in the construction industry with many project owners refusing to accept early completion baseline schedules. Others crafted contractual mechanisms prevent or defeat such claims.
  • COURSES: AML High-Risk Transactions - Identify, Manage, Resolve

    Overview This webinar will discuss the techniques for controlling and managing High Risk Transaction. The Instructor will discuss the parameters for identifying and qualifying transactions as high risk and process and communication to be followed. He will also discuss how to resolve the end result.
  • COURSES: The Top Ten Excel Functions Everyone Should Know

    Overview Excel functions can greatly enhance your ability to perform tasks in day to day activities in Excel. While there are hundreds of functions in available, there are 10 functions that all Excel users should know. Whether you are an office worker, or a small business owner using Excel to keep track of your finances or just the casual user, these Excel functions can be very important time savers and enhance your ability to create better performing spreadsheets!
  • COURSES: Effective Records Management & Document Control for Medical Devices

    Overview The document management system for medical device industry should help companies have control over critical activities such as: Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes Conducting Risk Assessment, Root Cause Analysis and Impact Assessment where appropriate Creating Action Plans, and verifying their effectiveness Improving efficiencies over the QMS tasks Reducing the risks of manual error Ensuring compliance to 21 CFR Part 11 and immutable audit trail Avoid observations, 483 letters and fines Taking the resource burden out of creating dashboards/ periodic reports
  • COURSES: A Second Life for SPC: From Control to Management

    In this presentation we will show how SPC can have a major impact on our businesses if we start using it as a managerial tool, Statistical Process Control (SPC) is one of the fundamental techniques in quality management, And This webinar will show you why and what you can do about it, The purpose is no longer to control a technical process but to manage your business processes in a much better way.
  • COURSES: Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions

    The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.
  • COURSES: Medical Device Software Validation Meeting FDA Regulations

    Overview: This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the testing that is required in addition to functional tests to produce a validated software product.
  • COURSES: Managing Complaints, Small Business Perspective

    This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received. You will learn about the key components in managing complaints such as tracking the complaint from time of receipt to completion, initiating and performing a complaint investigation, evaluating the complaint for medical device reporting, final review of the complaint and investigation and preparing a response to the complainant.
  • COURSES: The 7 Habits of Highly Effective Project Managers

    Overview: Too often Project Leaders and Managers fall into the role due to demonstrated technical competence. After all, if you're competent enough to create great technical output, certainly you can figure out how to run a project on schedule and within budget, right? And even when you get an opportunity to attend training to become a better Project Manager, the focus is on the "hard" or technical aspects of project management rather than the "soft" skills or habits that typically only come with experience.
  • COURSES: Electronic Records & Electronic Signatures; 21 CFR Part 11

    Today, more than 15 years after introduction, compliance with the requirements of Part 11 (as the regulation is now commonly referred to) continues to challenge the industry. As with any regulation, understanding the basic requirements is key to achieving compliance. This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements, and electronic signatures requirements.
  • COURSES: Deciding When to Submit a 510(k) for a Change to an Existing Device

    Overview: This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the "when to submit" decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision. Why should you Attend: Case Study Examples will be provided for each session to further assist the attendees in understanding how to decide when to submit a 510(k) for a change to an existing device.
  • COURSES: EU ISO 13485:2016 Medical Device Quality Management System

    This webinar will examine the changing focus of medical device regulation, similarities and differences between ISO 13485 and 21 CFR 820 (FDA's Device CGMPs), We will establish the correct definition of "risk", tied to ISO 14971 which has led to some major issues with companies selling to both the US and the EU.
  • COURSES: The Future of Quality Tools

    Several trends will influence business. For this presentation we are looking at three specific ones, and their impact on quality management and quality tools. The first trend is digitization, not just of business processes but also of society at large. A second trend is speed of change and reduced product life cycle time and linked to this a reduced time to improve a product after it has been released to the market. The third trend is the continuous increase of intelligent automation through Artificial Intelligence (AI) and self-learning systems.
  • COURSES: Conducting An Effective Recall (Managing Internal and External Customers)

    This webinar will provide you knowledge to establish a plan for conducting recalls, The knowledge you gain will sharpen your recall management decisions and strategy, And You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business.
  • COURSES: Audit Trail Generation and Review

    Computerized systems are used throughout the life sciences industry to support various regulated activities,which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA's 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions. One of the requirements for such compliance is the generation and review of audit trails. Thousands of audit trail records can be generated on a daily basis.
  • COURSES: 21 CFR Part 11 - Compliance for Electronic Records and Signatures

    This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
  • COURSES: HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

    The webinar provides a comprehensive overview of the mechanics of clean room HVAC, It is important that a clean room's HVAC system is fully understood, properly designed and properly validated, The webinar then provides valuable information on differential pressure, air velocity , flow rates, and air pressure balancing, Finally, a full set of requirements for HVAC system validation is detailed.
  • COURSES: Strategies to Prevent Manufacture and Distribution of Substandard Medications

    Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product. Yet, many companies pay too little attention to these problems, preferring short-term gain over long-term reputation and profitability. Within companies, it is common to hear the argument that quality is a cost center and does not directly contribute to the company's profits.
  • COURSES: Implementing Effective CAPA Systems

    The content of the webinar will focus on the practical and how to best thoroughly accomplish an effective CAPA system, also this webinar highlights the various regulations governing CAPAs, how CAPAs are successfully initiated and managed, how CAPA is an integral part of the quality system, and how an effective failure investigation and root cause analysis is accomplished.
  • COURSES: Quality Management Systems for Medical Devices

    This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU. Prior to engaging the process of establishing and certifying a QMS for medical devices or enhancing the QMS to the newly introduced requirements, a review of those requirements and how to approach them is important.
  • COURSES: Method Validation for the Detection of Microbial Pathogens in Foods and Feeds

    The presentation further describes evaluation criteria for methods to detect, identify and quantify all microbial analytes that may now be, or have the potential to be associated with foods and feeds, i.e. any microbiological organism of interest (target organism) or the genetic material i.e. DNA, RNA, toxins, antigens or any other product of these organisms.
  • COURSES: Practical Training & Employee Competency Management

    Training management is often focused only on aligning standard operating procedures with job titles, and tracking whether employees have been "trained" to the latest versions. But, quality standards and regulations actually focus on employee competence and awareness of their impact on quality. This webinar will help attendees to better understand the actual intent of the standards and regulations, how to better establish requirements for each employee, and how to confirm that employees are truly competent.
  • COURSES: Project Management for FDA-Regulated Companies

    This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.

Vendor Details

39658 Mission Boulevard, Fremont, CA 94539, USA.
Fremont, CA 94539
US
18004479407

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