Alfonso Fuller
President of Fuller Compliance, INC
Alfonso Fuller is the President of Fuller Compliance, Inc., a consulting firm that specializes in FDA quality system, software validation and software quality for pharmaceutical, biotech and medical device, nutraceutical and food manufacturers. He is a consultant, writer, and frequent presenter nationwide on quality system and software quality issues. His speaking appearances have included numerous national and statewide conferences.
Upcoming Webinar
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Recorded Webinar
FDA Warning Letter - Consent Decree Software Validation
This training on FDA software validation related warning letters will discuss what to do to avoid additional software related compliance issues along with the response steps where the citations directly or indirectly include automated system.
Recorded Session Get life time access for one participant with download option!

Spreadsheet Validation: Understanding and Satisfying FDA Requirements
Many companies struggle with spreadsheet compliance. Some are still using invalidated spreadsheets. Many companies lack an understanding of how to satisfy FDA technical validation requirements as applied to spreadsheets. Most organizations lack a clear spreadsheet compliance strategy. An unplanned 'emergency' spreadsheet validation project could paralyze the organization. This webinar will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements.
Recorded Session Get life time access for one participant with download option!

Software Validation and 21 CFR Part 11 Remediation Planning: FDA Inspection Strategies
All computer systems which store data which is used to make quality decisions or data which will be reported to the FDA must be compliant with 21 CFR 11. In laboratory situations, this includes any laboratory results used to determine quality, safety, strength, efficacy, or purity. In clinical environments, this includes all data to be reported as part of the clinical trial used to determine quality, safety, or efficacy. In manufacturing environments, this includes all decisions related to product release and product quality.
Recorded Session Get life time access for one participant with download option!

Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance
Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases.
Recorded Session Get life time access for one participant with download option!

21 CFR Part 11 compliance for Electronic Medical Records
This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.
Recorded Session Get life time access for one participant with download option!

Spreadsheet Validation: Understanding and Satisfying FDA Requirements
Many companies struggle with spreadsheet compliance. Some are still using invalidated spreadsheets. Many companies lack an understanding of how to satisfy FDA technical validation requirements as applied to spreadsheets. Most organizations lack a clear spreadsheet compliance strategy. An unplanned 'emergency' spreadsheet validation project could paralyze the organization. This webinar will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements.
Recorded Session Get life time access for one participant with download option!

FDA Warning Letter - Consent Decree Software Validation
This training on FDA software validation related warning letters will discuss what to do to avoid additional software related compliance issues along with the response steps where the citations directly or indirectly include automated system.
Recorded Session Get life time access for one participant with download option!

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