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EVENT DATE
Oct 2017
M T W T F S S
02030405060708
EXPO DATE
Oct 2017
M T W T F S S
02030405060708

Venue

Venue TBD
Oakland , CA 94577
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Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2015/2016)

Venue TBD
B2B 30

EVENT DESCRIPTION

 

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.

Who Will Benefit:

Those that will benefit from this program include anyone involved in the incoming materials, manufacturing, laboratory and packaging process within a non-sterile/aseptic pharmaceutical environment.

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality Control
  • Microbiology
  • Document control specialists

 

Note: Use coupon code REFERRAL10 and get 10% off on registration.

For Registration:

http://www.complianceonline.com/data-integrity-fda-who-ema-cgmp-seminar-training-80397SEM-prdsm?channel=eventsinamerica

If the Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2015/2016) is important to your business, act now and make the appropriate connections. See the contact information below.

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EVENT DETAILS

Primary Industry:
Sciences
Other Industries:
Business, Sciences
Audience:
Quality professionals
Regulatory professionals
Compliance professionals
Manufacturing engineers
Quality engineers
Quality auditors
Quality Control
Microbiology
Notes:
Show Owner:
ComplianceOnline
Sponsorship:

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Show Owner
ComplianceOnline

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