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 1463 results
  • COURSES: Root Cause Analysis to Meet FDA Expectations - 2017

    Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. Why should you Attend: A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that such effective and repeatable failure investigation and root cause analysis is still not the industry norm.
  • COURSES: Guidelines for New FDA Transfer of Analytical Methods - 2017

    Overview: When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Areas Covered in the Session: Four approaches for analytical method transfer and testing Responsibilities of the transferring and receiving laboratory Developing a transfer plan and a pre-approval protocol
  • COURSES: Medical Device Employee Training - 2017

    Overview: This is especially true for start-up and other small medical device companies, or rapidly growing companies. Specific FDA training requirements will be presented. Why should you Attend: This presentation will provide information and tips on best practices for assuring your employees are properly trained and you can demonstrate it. Improperly or inadequately trained employees lead to both product and process nonconformities.
  • COURSES: Phase I GMPs clinical trials - 2017

    Overview: Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Why should you Attend: Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
  • COURSES: FDA Scrutiny of Promotion and Advertising - 2017

    Overview: DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. The days of looking at text alone for a magazine insert are long gone. Why should you Attend: That is expensive and leaves you with a cloud over your name at the FDA. That is never a good thing. You must know what you are doing with DTC advertising, not just hope you do. You will probably earn a Warning Letter by "Winging it."
  • COURSES: How FDA Trains its Investigators to Review CAPA - 2017

    Overview: In this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.
  • COURSES: Implementing a Technology Transfer Process - 2017

    Overview: It will cover the concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help capture the knowledge. Why Should you attend: However execution of that transfer is complex involving the interactions of many disciplines across an organization.
  • COURSES: Excel Spreadsheets - Step-By-Step Instructions - 2017

    Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Areas Covered in the Session: Develop spreadsheet applications that are GxP compliant. Learn how to use Excel’s built in 21 CFR Part 11 features. Validate your application with minimal documentation.
  • COURSES: Understanding International ACH - 2017

    Overview: Instructor will cover customer benefits and value proposition regarding International ACH and why it may be preferred over wire transfers. Why should you Attend: This webinar will explain what International ACH is, how it works and more about an organization that is creating global standards to make it even easier. It will discuss the rationale for choosing International ACH and how it differs from US domestic ACH.
  • COURSES: Tools for Human Error Reduction - 2017

    Overview: Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Areas Covered in the Session: Background on Human Error Phenomena and measurement. Importance of Human Error Prevention/reduction. Quantitative and qualitative information gathering.
  • COURSES: FDA current recommendations on using electronic health records - 2017

    Overview: This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination product.
  • COURSES: Good Deviation Practice - CAPA Process - 2017

    Overview: This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. Why you should attend: The attendee will learn the best practices for the deviation process and the important points from a regulatory standpoint.
  • COURSES: Review process on Advertising & Promotional material compliance - 2017

    Overview: You will hear about the opportunities for input from regulatory agencies at critical stages and on key promotional materials and you will hear strategies for implementing review process and procedures to facilitate high compliance standards. Why should you Attend: This webinar will address issues of compliance in the creation of advertising and promotional materials and the appropriate internal assurances that compliance of materials is appropriately assessed, evaluated, and documented.
  • COURSES: How to Meet FDA QSR and ISO 13485 Requirements - 2017

    Overview: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.
  • COURSES: Webinar on How to Conduct a HIPAA Risk Assessment

    This webinar will cover concepts involved in a security risk analysis and overall risk management. Sample assessment questions will be reviewed and guidance provided on how to make risk level determinations based on responses. Documenting the results of the risk assessment will covered. If your healthcare practice or business needs to understand how to conduct a HIPAA Risk Assessment, please join us for this informative and interactive session.
  • COURSES: 2017 Webinar on HIPAA Compliance for Dental Practices

    Training Options Duration: 90 Minutes Tuesday, May 2, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: This webinar will cover the implementation specifications pertaining to administrative, technical and physical safeguards that must be in place under the Security Rule along with overall best security practices for PHI. The HIPAA Privacy Rule as it pertains to patient's rights, access to medical records, disclosures and best practices to safeguard personal health information will be covered. The webinar will explain how HIPAA breaches occur and look at specific dental practice case examples. Suggestions will be provided on how to create a culture of compliance within your practice. If your dental practice needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive session.
  • COURSES: Webinar on Off-Shore Business Associates

    The global Internet of Things and the HIPAA Privacy and Security Rules allow Protected Health Information (PHI) created by Covered Entities in the United States to be transmitted and stored outside the United States - and outside the reach of U.S. government regulators. Risks for Covered Entities, patients and Business Associates may lurk anywhere in a world where identity theft is rampant and medical identity is the Golden Egg for identity thieves.
  • COURSES: Webinar on New HIPAA Compliance Audit Program

    In this session we will discuss the HIPAA audit and enforcement programs and how they work, and discuss the areas that caused the most issues in prior audits. We will explore what kind of issues and what kind of entities had the most problems, and show where entities need to improve their compliance the most. We will also explore the typical risk issues that lead to breaches of health information and see how those issues may be a target for auditors in the nxt round of audits.
  • COURSES: Webinar on Claims Adjustment Reason Codes

    Claim denials results in nonpayment, which in return results in a lack of cash flow. This impacts all healthcare providers, but may significantly impact smaller practices. Denials also affect practices, as additional resources and cost may be required to address denials. Even after much effort it may be too late to appeal a denial, resulting in a permanently denied claim. Attendees will learn how to better identify denials, understand CARC and RARC's and their impact on denials.
  • COURSES: Webinar on Managing Risks Under HIPAA

    This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.
  • COURSES: Webinar on 2017 Principles of IRB Review

    IRBs have the complex task of reviewing research in compliance with human subject regulations and conducting an ethical review of the research. This webinar will help organizations complete both of these functions.
  • COURSES: Webinar on HIPAA Enforcement Activity

    Now that the HIPAA rules have been in place for more than a dozen years, the days of advice and counseling have been replaced by a hard-nosed enforcement attitude, where HHS OCR is ready to make health care organizations that violate the rules feel some pain for their actions. If your organization is not ready, the HIPAA rules have new, significantly higher fines, including mandatory minimum fines of $10,000 for willful neglect of compliance. In addition, HIPAA enforcement has taken on a new importance at HHS; officials have publicly stated that enforcement is now a priority, and that means being ready for an audit or compliance review is more important than ever.
  • COURSES: Webinar on CMS CERT "Comprehensive Error Rate Testing"

    Compliance, billing and healthcare operations will benefit by understanding how the CERT program works and how it affects your organization and reimbursement. Attendees will learn how to respond to CERT requests and how to implement prevention strategies to improve compliance
  • COURSES: Webinar on Recognizing and Responding to Personality Disorders in College Students

    As the number of students with personality disorders continues to increase on our college campuses, administrators, faculty and staff are hard pressed to respond effectively to their special needs. Providing these students with a quality education requires commitment, education and training, and an in-depth and operational understanding of the special needs of these individuals. This webinar will provide participants with the knowledge and skills they need to effectively meet the needs of this unique and growing population.
  • COURSES: Webinar on HIPAA Audits

    I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I’ve been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017.

Vendor Details

161| Mission Falls Lane| Suite 216, Fremont| CA 94539
Fremont, CA 94539
US
18004479407

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