Data Integrity: FDA, WHO and EMA's Requirements

  • 1299.00 Dollar US$
  • Published date: August 27, 2021
    • san Jose, california, United States

Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed within the United States. A lack of Data Integrity hints of a Company being outside of compliance and questions the quality of the product being produced.

Often the initial "hint" of an off-shore problem occurs within FDA "circles" when one first observes an "Import Alert". These Import Alerts don't offer much information other than the country, the Company and the product. However, this becomes a tell-tale signal that a Warning Letter will most likely be issuing within three to four months.

Data Integrity issues may represent very simplistic issues that any auditor may readily observe to those that are so complex that only someone very skilled in the art of auditing can readily find them. During this two day seminar various examples of Data Integrity issues will be reviewed to include how and where to locate them during audits. In addition, breakout sessions will be held to learn from each other and other teams as they review the same data and compare their findings. Interestingly, conclusions developed by the various teams often differ from each other.

Several documents have recently been published by the FDA, MHRA and WHO. The FDA Guidance for Industry, "Data Integrity and Compliance with CGMP" was published as a DRAFT guidance in April 2016. This Guidance was issued to clarify the role of Data Integrity in CGMP for drugs. In March 2015, the MHRA published a Guidance entitled "MHRA GMP Data Integrity Definitions and Guidance for Industry" which mirrored the 2016 FDA document. Other documents include ‘GXP’ Data Integrity Guidance and Definitions” in March 2018 and “Data Integrity and Compliance With Drug CGMP, Questions and Answers in December 2018”. Various source documents to include 21 CFR 210/211, FDA Guidances for Industry, Standard Industry Practices and other International sources will be used to support the conclusions developed by each team during this two day seminar.

The objective of this two day ComplianceOnline seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program and how to maintain Quality Systems that minimize these issues. This seminar is designed to assist in assuring that your organization is maintaining itself within cGMP compliance. Case studies to include Warning Letters will be discussed to illustrate the wide array of issues that continue to arise and how to find them within your organization and your vendors before the regulators find them for you. This seminar represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.

Result 0 votes
Ashutos Swain
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • How to Prepare a Standard Operating Procedure (SOP)?

    How to Prepare a Standard Operating Procedure (SOP)?

    Laboratory Equipment and Instrumentation san Jose (california) May 23, 2021 199.00 Dollar US$

    Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance diffi...

  • Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

    Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

    Laboratory Equipment and Instrumentation san Jose (california) May 22, 2021 1699.00 Dollar US$

    The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. This new upcoming regulation is also stronger connected to the EN ISO 13485:2016. The understanding of this changes and how to implement last minut...

  • Fundamentals of EU MDR and IVDR – Level 1

    Fundamentals of EU MDR and IVDR – Level 1

    Laboratory Equipment and Instrumentation san Jose (california) May 22, 2021 1499.00 Dollar US$

    This 2 day seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Device Regulation (IVDR), provide case studies and share lessons learned so your organization can benefit from the mist...