The latest approach for complying with 21 CFR Part 11

Speaker

Instructor: Sam Mistretta
Product ID: 700664

Location
  • Duration: 60 Min
This 21 CFR Part 11 training/webinar will provide valuable assistance to all regulated companies that need to comply with 21 CFR Part 11.
RECORDED TRAINING
Last Recorded Date: Oct-2007

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$500.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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Why Should you Attend:

Organizations must first develop an interpretation of 21 CFR Part 11 compliance particular to that organizations IT infrastructure, operations, and procedures. From this a targeted re-useable training and validation model can be established. Part 11 can be thought of as a common thread that is weaved throughout the organization touching all aspects of GMP compliance where hardware and software applications are utilized. Configuration Management of complex laboratory and manufacturing systems plays a key role in identifying risk within a given process. Giving end-users the proper tools and training ensures effective monitoring and change management can occur.

Areas Covered in the seminar:

  • Defining the scope of 21 CFR Part 11.
  • Interpreting the rule.
  • Applying the rule.
  • Road to compliance.
  • Validation considerations.
  • Training for part 11.
  • Monitoring for compliance.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to comply with 21 CFR Part 11 including companies in the Pharmaceutical, Biopharmaceutical, and Medical Device field. The employees who will benefit include:

  • Regulatory Affairs
  • Quality Assurance
  • Information Technology
  • Laboratory Managers
  • Validation Manager

Instructor Profile:

Sam Mistretta, is the founder and CEO of CyberVal Pharma, Inc. a consulting firm that specializes in technical, regulatory, and scientific services for the pharmaceutical, biopharmaceutical, and medical device verticals. Sam is a Microsoft Certified Systems Engineer degreed in Interdisciplinary Natural Sciences with bench experience in the microbiology and chemistry laboratories for QC & R&D GMP environments. One central focus has remained complying with 21CFR Part 11 and all the challenges this presents.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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