Referral R - Academic Profile at OpenHigherEd.com

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Referral R

Basics

Name:
Referral R
Location:
California, United States
Area of Interest:
Arts and Architecture
(School) Network:
Academy of Art University
HigherEdSpace Profile:
http://www.openhighered.com/profile/15321147

Interests

Bank secrecy act	BSA training
BSA compliance	BSA rules and regulations
BSA violations	BSA best practices
comprehensive risk assessments	BSA monitoring program
AML compliance	anti-money laun
GMP requirements	raw materials
warning letters	raw material management
GMP regulations	risk management
vendor selection	validation
FDA inspection	quality control
Certificates to foreign governments	export certificates for medical devices
sections 801(e)(1) fd&c act	802 fd&c act
cdrh export certification and tracking system	cecats
UDI	unique device identification
implementation planning	GUDID
device labelling requirements	medical device reporting
QSR quality system regulations	global unique device identification database
Biologics Stability Programs for Biopharmaceuticals	Forced Degradation Studies
BLA registration	stability study for biologics
WCP stability study	hr audit documentation
hr audit process	transformational human resources
Human resource process management	human resource audit design
hr audit considerations	Data breach
data breach legal implications	risk management best practices
risk of data breach	cost of data breach
preventing data breach	data breach legal responsibility
CGMPS for combination products	combination product regulations
21 CFR Part 4 requirements	FDA regulation of combination products
combination product CGMPs	combination product good manufacturing p
Failure investigations	out of specification investigations
OOS investigations training	viable excursion limits
non-viable excursion limits	alert limit
action limit	OOS investigation documentati
Harmonized tariff schedule	harmonized codes
pharmaceutical classification	chemical classification
harmonized tariff schedule chapter 30	harmonized tariff schedule chapter 29
import and export un	Supplier Evaluation and assessment
medical device quality requirements	medical device supplier evaluation
medical device supplier	quality system regulation
ISO 13485 requirements	medical device
Behavioral interviewing	applicant interview best practices
interviewing strategies	behavior-based interview
reference checking	employment laws
recruitment interviewing	GAMPÂ® 5 training
GAMPÂ® software validation	FDA software validation
FDA validation	FDDA software validation
successful validation	FDA software validation requirements
FDA regulations	Standard Operating Procedures
SOPs	Code of Federal Regulations
Title 21	Title 493
regulatory errors	SOP validation
risk-based approach	Personnel records management system
records retention	personnel records audit
personnel	Quality & Regulatory Professionals
Manufacturing & Design Engineers	Marketing Product Managers
Corporate & Operations Executives	Validation specialists
21 CFR Part 11 Compliance	Annex 11 Compliance
Avoid 483s	Warning Letters
10-step risk-based validation approach	COTS software validation
Failure investigations	out of specification investigations
OOS investigations training	viable excursion limits
non-viable excursion limits	alert limit
action limit	OOS investigation documentation
OOS investigation actions	OOS
out of specification	medical device manufacturing
manufacturing process	Pet food labeling
FDA standards for animal feeds	FDA pet food labeling guidelines
AAFCO Pet Food Regulations	Ingredient List
Label Requirements for Pet Foods	pet feeding directions
animal food	FDA Compliant CAPA
FDA Expectations for Root Cause Analysis	Failure Investigation Methodology
GMP Audit	Non-conformance
OOS resolution	Complaint Handling
Adverse Event Reporting and Resolution	Verification and Validation activities
Global regulatory plan	global regulatory affairs
reimbursement issues	intellectual property issues
Canada regulations	US regulation
EU regulations	regulatory strategy
21 CFR Part 11	excel spreadsheet validation
FDA requirements	Excel spreadsheet validation
21 cfr part 11 compliance	develop and validate excel spreadsheets
gxp compliant excel spreadsheets	excel for audit trails
spreadsheet security features	data entry verification
Cloud computing	service level agreement
assessments of cloud hosting facilities	cloud computing regulatory challenges
computer validation and electronic records	cloud provider assessments

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Basics

Interests