Hi, Our website is - one of the largest training portals in the USA and Europe for the past 10 years. We organize industry expert-driven training seminars / webinars for all industries. Our Trainings are meant for : All Corporate Decision makers (CEOs, CTOs, CMOs, All purchase managers, all department heads ) Risk management officers Process engineers Quality officers/assurance managers Documentation/Records department officials Financial officers and all related to risk and compliance in companies. HR Managers OSHA compliance officers /managers. Business Development Professionals Consultants


Showing 1051-1075 of 1075 results
  • COURSES: GMP Requirements for Validation and Re-Validation of Analytical Procedures by Kim Huynh-Ba

    Upon completion of this session, attendees will understand cGMP and ICH validation requirements for analytical procedures and learn key factors that would affect validation process of analytical procedures. It will help scientists develop process for evaluation method validation, review changes, and determine when re-validation would need to take place. It will discuss observations and infractions related to method validation.
  • COURSES: Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation by Jessica Czamanski

    Areas Covered in the Webinar: Concept of quality management system All clauses in ISO 13485 Auditable clauses of ISO 13485 All parts of the FDA’s QSR Who is responsible for complying with QSR Differences between ISO 13485 and QSR Role of management in quality Exclusions from specific parts of the regulation or standard Internal audit requirement Who Will Benefit: Medical device manufacturers R&D teams for medical devices Personnel involved in the packaging of medical devices and packaging engineers Inventory control personnel in a medical device company Quality personnel and quality engineers Suppliers to medical device companies Biomedical engineers Manufacturing engineers
  • COURSES: Analyzing Financial Statements for Fraud by Craig L Greene

    Areas Covered in the Webinar: Definition of Financial Statement Fraud Common Reasons for Financial Statement Fraud Red Flags to Look for in Fraudulent Financial Statements Basic Understanding of How Financial Statement Fraud is Committed Analysis used to Detect Financial Statement Fraud Other Methods of Vetting Financial Statements Who Will Benefit: Investors and their brokers, money managers, etc. Lending officers Credit and collection department personnel M&A personnel Financial institution compliance personnel Banking compliance personnel Internal auditors External auditors
  • COURSES: Verification vs. Validation in Regulated Industries by John Chapman

    Areas Covered in the Webinar: Verification & validation types. Definitions. Design control. Process control. Application. Consequences of poor verification & validation. Why verification & validation makes good business sense?
  • COURSES: Schedule M-1/M-3 and Schedule UTP Reporting and Companies Requirements By:Cherie J. Hennig, Ph.D, CPA

    Learning Objectives: Gain a practical understanding of the Schedule M-3 reporting and disclosure requirements. Learn about changes to Schedule M-3 reporting requirements for 2014 tax year. Learn about how to complete Schedule M-3 for a parent-subsidiary consolidated group. Understand how to identify and substantiate uncertain tax positions on the Schedule UTP. Learn why it is important to “get the numbers right” when completing Schedules M-3 and UTP.
  • COURSES: Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency by Dr. Harvey Rudolph, HRRM, LLC (Ex-FDA Official, ISO 14971 S

    Learning Objectives: To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle To demonstrate the requirements of ISO 14971, how they reflect FDA concerns To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012 To provide attendees with the Dos and Don'ts for an effective and efficient risk management system.
  • COURSES: Statistical Analysis for Product Development by Steven Walfish, President of Statistical Outsourcing Services

    Learning Objectives: Learn the technical details and rationale for selecting and analyzing well designed statistically based experiments. Develop the confidence to design and execute experiments that maximizes information in your day-to-day activities. Participate in discussions with other course attendees to increase your confidence and proficiency in statistical hypothesis testing. Determine the most robust settings in your process to minimize the different sources of variability.
  • COURSES: Business Continuity and Scenario Planning By:Richard Barr, Operational Risk & Back Office Specialist

    The vital role that financial intermediation plays in facilitating and promoting national and global economic activity by providing the means for making and receiving payments, for borrowing and lending, for effecting transactions, for insuring risks, and for raising capital and promoting investment The increasing complexity and operational risk across financial systems. The concentration of clearing and settlement processes in most financial systems. Deepening interdependencies among financial industry participants within and across jurisdictions. The recurring pattern of natural disasters or extreme weather conditions. The possibility of terrorist or other malicious attacks targeted, directly or indirectly, at the infrastructure of the financial system. A strong interest in maintaining public confidence in financial systems. The objectives of this course is to provide professionals in the banking and financial sector with a sound foundation in the area of business.
  • COURSES: How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach: One and a Half day In-Person Seminar

    The FDA inspection is one of the critical measures of your quality system and your organization as a whole. Since a perfect quality system is usually not implemented, the preparation for and management of an FDA inspection is critically important. A well-established quality system provides a solid foundation for passing FDA inspections; however, if you don’t proactively examine your quality system from the perspective of a FDA inspector, you can still have difficulties. Note: Use coupon code 232082 and get 10% off on registration.
  • COURSES: Managing an Effective AML Compliance Program By:Laura H. Goldzung, President and Founder of AML Audit Services, LLC

    Regulatory frameworks surrounding anti-money laundering Objectives of an effective AML compliance program Risk assessing your institution Developing robust internal controls Training for appropriate personnel Expectations and duties of the appointed compliance officer Effective audit program to ensure adequacy of your AML compliance program.
  • COURSES: Risk Assessment, Assessing Internal Controls and Financial Statement Audit

    Learn how to conduct a risk assessment Be able to design internal controls Be able to evaluate and assess internal controls Know what are key preventive and detective controls Learn how good internal controls can reduce audit costs.
  • COURSES: FDA's New Import Program for 2019 - Strict Precision:2-Day In-Person Seminar by Ex-FDA Official

    You will be able to answer the following questions with this course without saying, “I don’t know?” What are the FDA’s import legal requirements and policy? How do you deal with the FDA and the U.S. Customs and Border Patrol procedures? What happens when your product is detained? What happens if a foreign manufacturer is in trouble with the FDA? How do you inter-act with the FDA to work out problems? Why are import and export rules different or does it even matter? Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent 32 years in FDA and his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.
  • COURSES: Comprehensive Training Workshop: Risk Based Internal Auditing (RBIA)

    Learning Objectives: By using the RBIA approach, the organization’s internal audit should be able to conclude that: Management has identified, assessed and responded to risks within and beyond the organization’s risk appetite That the responses to risks are effective but not excessive in managing inherent risks within this risk appetite Where residual risks are not in line with the risk appetite, action is being taken to remedy this Risk management processes, including the effectiveness of responses and the completion of actions, are being monitored by management to ensure they continue to operate effectively Risks, responses and actions are being properly classified and reported.
  • COURSES: FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy

    Learning Objectives Upon completing this course participants will understand: Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k) When to file for a new device, a change in the intended use or a change in the technology of a cleared device What is contained in a traditional, abbreviated and special 510(k) submission package The submission package, user fees and making an eCopy What is substantial equivalence and what’s required to show substantial equivalence What’s required on the labeling and IFU Which performance tests should be conducted and how to present the data to the FDA The requirements for a risk management plan and report Understand the FDA’s Refuse to Accept Policy What is required in a submission for software controlled devices How and when to use third party reviews When clinical data may be required.
  • COURSES: Operations Risk Management and Mitigation - from Assessment to Implementation

    Recently, a series of headline-grabbing operational risk incidents at banks, other financial institutions and even regulators have again brought the issue of operational risk management to the forefront of the agendas of CEOs, CROs, risk managers and internal and external auditors alike. These incidents are wide ranging and flow from bank ATM collapses, bank operating system failures, regulatory settlements in the ongoing US sub-prime mortgage saga, rogue traders and the connected risk managers who either missed or were willfully blind to all the warning signs. Key objectives and learning outcomes The aim of the course is to provide: Illustrate risk in all its facets What the Basel Accords say about operational risk and its mitigation Listing operational risk techniques for assessing, managing and mitigating operational risk Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • COURSES: Manufacturing and Marketing Cosmeceutical* and Homeopathic OTCs: Complying with FDA's Rules for Drug Products that do not require FDA Pre-App

    Understand FDA rules and policies regarding manufacturing and labeling of low risk OTC drugs not covered by approved New Drug Applications. Learn the definitions of drug, cosmetic, dietary supplement. Understand how labeling other than labels and advertising can define a product and cause it to be misbranded or considered a new drug. Differentiate cosmetic “puffery" claims from claims that FDA would likely consider drug claims. Understand the differences between allopathic (conventional) drugs and homeopathic drugs. Recognize ways to manufacture low health risk products at minimum cost, yet still meet the intent and basic requirements of GMP regulations. Learn how to minimize the regulatory risk of a Warning Letter or other FDA action.
  • COURSES: HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer

    With the recent implementation of new HIPAA regulations in the HIPAA Omnibus Update of 2013, healthcare organizations are reviewing their compliance and making sure they have the proper policies, procedures, and forms in place. HIPAA Privacy Officers have been renewing their compliance activities and reviewing their documentation to make sure they can meet the challenges of the new rules and avoid breaches and penalties for compliance violations. Who will Benefit This seminar will provide valuable assistance to all personnel in medical offices, practice groups, hospitals, academic medical centers, insurers, business associates (shredding, data storage, systems vendors, billing services, etc.). The following personnel will find this session valuable: Compliance director CEO COO CFO Privacy Officer Security Officer Information Systems Manager HIPAA Officer Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • COURSES: Conflict Minerals 2014: Looking Back and Looking Ahead

    Understand the SEC disclosure requirements based on new information and the 2013 filings Apprehend key definitions and applicability Be able to clearly delineate between RCOI and due diligence Identify weaknesses in supplier data and ways to improve its reliability and credibility Understand various CMR approaches and implications Identify cost savings opportunities related to the IPSA Recognize where they stand in relation to peer companies based on 2013 filings.
  • COURSES: Quality Management, GMP and Regulations - Impact on Food, Seafood and Nutritional Supplements

    Understand the importance of food and nutritional supplement GMPs in protecting the public See the impact of poor GMP performance Become a HACCP subject matter expert Understand the impact on product quality and on business success Know how facility design affects product quality Understand the dos and don’ts of product promotion, websites and social media Learn about GMP validation – when is it required? Understand how cleaning agents work and the best way to choose a cleaning agent See the impact of proper documentation and record keeping Understand why cleanliness is the key to success.
  • COURSES: Enterprise Risk Management

    How to determine the risks for your organization – how to get started on the ERM journey. How to weight risk to determine the key risks – not all risks are created equal. How to develop a common risk language – ERM has a language that needs to be customized for your organization. How to determine risk appetite – learn the steps for establishing your organization’s risk appetite. Which is the appropriate risk framework for your organization – evaluate the different risk frameworks. How to develop and prioritize a risk portfolio – develop an ERM heat map. How to develop your management’s risk tolerance – a tactical consideration for your ERM journey. Who is responsible for the risk – what are the roles of the Board of Directors, Executive Management, Chief Risk Officer and Internal Audit How to decide to avoid, accept, reduce or control a risk – how do you respond to the risks identified. The appropriate risk monitoring and reporting processes .
  • COURSES: Biotech/Biosimilar Products: Current and Emerging Analytical CMC Expectations

    Learning Objectives: Recognize the system of worldwide regulatory guidance applicable to biotech and biosimilar product CMC requirements Understand why requirements for biotech products are so different from those of chemical products Find exactly ‘where it is written’ for current and emerging CMC expectations for biotech/biosimilar products, and get copies of those regulatory documents See how to implement a staged approach to establishing specifications for release and stability testing Learn the current analytical technologies used for establishing biotech/biosimilar product characteristics and assessing comparability Select the appropriate methods for release and stability testing Design suitable qualification and validation exercises for method intended uses Establish stage-appropriate ICH stability protocols Learn the tiered approach for managing product reference standards Recognize how much R&D data are exposed to regulatory scrutiny
  • COURSES: Post-Market Compliance for Medical Devices and Evolving Reporting Requirements: Complaint Handling, MDR/eMDR and Recalls including UDI update

    This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years’ experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions. Learning Objectives: Understand how to comply with complicated Compliant Handling, MDR and Recall requirements. Firms MDR reporting and FDA's handling of reports. Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA. Who will Benefit: This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting. Regulatory Affairs QA/QC Project Managers Regulatory Professional Risk Managers Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • COURSES: Fundamentals of Operational Risk Management - from Assessment to Implementation

    The aim of the course is to provide: An understanding of risk in all its facets What the Basel Accords say about operational risk and its mitigation An understanding of operational risk techniques for assessing, managing and mitigating operational risk A link between ORM theory & practice A clear "road-map" on how to implement an ORM structure in practice in a banking organization.
  • COURSES: Fundamentals of Antitrust and Competition Law: What you need to know to identify issues, mitigate risk and maximize flexibilit

    Learning Objectives: Understand the kinds of business activity the antitrust laws absolutely prohibit, the kinds it permits if properly justified, and the kinds it does not apply to at all. Learn the broad goals and objectives of the antitrust laws, Possess a sensitivity to the specific business practices that can be considered anticompetitive, Be able to communicate to others the reasons a particular practice could raise risk and should be brought to the attention of counsel or upper management, Have a better ability to evaluate whether your company is the victim of an antitrust violation or unfair business practice, Learn specific strategies for reducing the risks of communications with competitors, Understand and reduce the risks of joining trade and professional organizations, of conducting surveys and participating in benchmarking studies, Understand the significance to your business of antitrust decisions and enforcement actions reported in the press.
  • COURSES: Smart Tax and Accounting Solutions for Small Business:

    If you are looking for answer of these questions, you would certainly benefit by attending this seminar: Are you a new or current small business owner who would like to ensure your business is organized to protect your assets and maximize your potential financial returns? As a non-accountant, are you unsure how your books should be kept? Do accounting concepts seem like a foreign language? Do you want to save on taxes, and make sure you are in compliance with tax laws? Do you want to understand what you should expect from the person that prepares your income tax returns and plans your tax strategies?

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