Webinar on Auditing Testing Laboratories for FDA Compliance – ResearchAndMarkets.com | Nation/World


The webinar “4-Hour Virtual Seminar on Auditing Testing Laboratories for FDA Compliance” has been added to the ResearchAndMarkets.com offering.

There are two phases in this subject. The first is the audit itself. Good audits are well structured. They must take into account the reasons for the audit, the regulatory requirements as well as the nature of the audited laboratory. We will discuss the considerations that need to be made when auditing a laboratory. The social interactions to be expected, the nature of regulatory requirements, and the nature of the work performed by the laboratory will be discussed.

The second phase examines what needs to be taken into account during the audit itself. Audits conducted by inexperienced or ignorant auditors are often worthless, wasting time and money for the auditors and the audited laboratory. Auditors familiar with laboratory operations are necessary because it is easy to be fooled into thinking that a non-compliant laboratory is operating normally. Different types of labs will require different auditors/specialists. We’ll discuss the pitfalls auditors can fall into and questions labs can expect to face.

Why should you attend

It is necessary for a business to know whether a testing laboratory is capable of operating in accordance with GMP or other regulations. This is especially critical if the laboratory is a quality control laboratory whose test results will be used to support the release of a product to the public or to support an application for authorization to market a product. Non-compliance with regulations by a quality control laboratory can lead to the failure of a marketing authorization application for a product or the forced recall of a marketed product.

In extreme cases, a revocation of the authorization to market a product may result. In all cases, failure to comply with regulations will result in loss of confidence in the manufacturer’s ability to manufacture a product that meets quality and regulatory requirements, and, in turn, will lead to a refusal to purchase. ‘a product.

It is essential that the laboratory audit is conducted in a professional manner, as a poor audit will waste money and lead to false confidence in the capabilities of the laboratory being audited, whether internal or external to the company.

Who should attend:

  • Potential listeners
  • Supervisors who must initiate audits
  • Supervisors and lab workers
  • Quality assurance and control supervisors and key workers
  • Supervision management should select contractors
  • Managers
  • Directors
  • Vice presidents who oversee quality assurance
  • Quality control
  • Regulatory Affairs Groups

Main topics covered:

  • Choose who should be audited
  • Decide on regulatory requirements
  • Audit team selection
  • Contact the laboratory and request the audit
  • Initial interactions
  • Constitution of the audit file
  • Set audit dates
  • Organization of travel and accommodation
  • The opening meeting
  • The actual verification. Be sure to cross the lab
  • Talk to the technicians
  • Evaluate instruments
  • Follow the path of a sample and the test results
  • Data integrity is an issue to consider
  • Assessment of data integrity issues
  • Test reports and certificates of analysis
  • The team meeting
  • The closing meeting. All potential issues and observations should be discussed
  • The thank you letter. Be sure to give a date for the audit report
  • Responses to the audit report
  • Closing of the audit

For more information on this webinar, visit https://www.researchandmarkets.com/r/9mpkcn

See the source version on businesswire.com: https://www.businesswire.com/news/home/20220914005713/en/

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SOURCE: Research and Markets

Copyright BusinessWire 2022.

PUBLISHED: 09/14/2022 11:14 AM/DISC: 09/14/2022 11:14 AM


Copyright BusinessWire 2022.