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Name:
John Robinson
Location:
California
,
United States
Area of Interest:
Health
(School) Network:
Not Specified
Website:
Visit my website
HigherEdSpace Profile:
http://www.coursepedia.com/profile/82214805
Interests
online training
Excel Spreadsheet Validation
Eliminate 483s
21 CFR Part 11
GxP environments
online training
FDA 483 Observations
Laboratory controls
sampling plans
test procedures
online training
Investigational Medicinal Product Dossier
IMPD
Cross-Agency Interactions
EU vs. US Treatment
online training
Change Control Management
Design Change Control
URS
FRS
Design Specifications
online training
Statistics in Quality Control
SPC
Basic Statistics
online training
U.S. FDAs Strategic Priorities
FDA's Life Cycle
FDA Clearance
Global Supply Chain
online training
FDA's Revised
Draft Guidance
510(k)
FDA's K97-1
Decision Tree
online training
Portfolio Optimization
Global Drug Development
Portfolio planning
strategic portfolio planning
online training
Key Steps for Risk Assessment
ICH Q9 Process
QRM tools used
online training
Dietary Supplement
Regulatory Compliance
Labeling
Product Claims
Supplements vs. Pharmaceuticals
OTC Drugs
Conventional Foods
DSHEA
GMP Requirements
FDA vs. FTC
online training
ISO 14971
FDA-ICH Q9
Risk Management
ICH Q9
Hazard Analysis
FMECA
FTA Templates
online training
Supplier Audit Program
Hot Buttons
COA
COC
remote audits
online training
Risk Analysis
Drug Development Programs
portfolio planning
portfolio selection
capacity planning and risk management
risk mitigation strategies
online training
Computer System Validation
risk-based validation approach
link requirements
specifications
risk management
testing
online training
Residual Moisture Testing
Proven Techniques
spectroscopy method
residual moisture testing
Volumetric Karl Fischer titration
Coulometric Kark Fischer titration
sealed vials
online training
Risk Assessment
Compliance
hazard analysis
Traceability
establish mitigations
india seminars
USFDA
Pharma covigilance
Inspections and Audits
Signal Detection
ICH
Steve Jolley
Pharma Consulting
mumbai seminars
online training
Risk Control Strategy
RCS
QRM stakeholders
QRM's success factors
validation services
online training
Pharmacovigilance
Project structure
Business Process Management
compliance
safety perspectives
Business Process Optimization
clinical trial
regulatory environment
online training
South Korea Healthcare System
ICH
online training
Importing and Exporting Medical Devices
Regulatory Strategy
FDA references
Import Alerts
FD&C Act
online training
FDA Compliance
Medical Device Labeling
Off Label Promotion
off-label information
FDA's current recommendations
online training
Title 21
Code of Federal Regulations
Good Laboratory Practice
GLP
Investigational New Drug Application
IND
Investigational Device Exemption
IDE
online training
Product Complaint Investigations
CAPA
FDA hot buttons
closed loop investigations
complaint management system
online training
Standard Operating Procedures
SOPs
Guarantee FDA Compliance
FDA Form 483s
Warning Letters
EU requirements
SOP revisions
seminar delhi
Angela Bazigos
21 CFR Part 11 Compliance of Computer Systems
Validation Systems
FDA
Validation Plan
Laboratory Information Management System
seminar Bangalore
Angela Bazigos
21 CFR Part 11 Compliance of Computer Systems
Validation Systems
FDA
Validation Plan
Laboratory Information Management System
Seminar Pennsylvania
DHF
DMR
DHR and TF
Regulatory Documents Explained
FDA and ISO regulations
Jeff Kasoff
seminar San Francisco
Angela Bazigos
21 CFR Part 11 Compliance of Computer Systems
Validation Systems
FDA
Validation Plan
Laboratory Information Management System
seminar San Diego
Steven S Kuwahara
GMP
Regulatory Expectations
IND Products
ICH Q8
Pre IND Studies
CMC requirements
IND Meetings
Boston Marriott Long Wharf
8 AM to 5 PM EDT
seminars
Risk Management
Medical Devices Industry
application of risk management
Hazard latency issues
Mitigation strategies and priorities
Critical software issues
seminar Washington DC
Statistics for the Non-Statistician
Hypothesis Testing
Excel - SAS
FDA requirements
OOS results
Regression analysis
Design of Experiments
Validate Testing Methods
Trending Analys
seminar Pennsylvania
A to Z’s of Microbial Control
Troubleshooting of Pharmaceutical Water Systems
Trouble Free Water Quality
Validated System
Controlling Endotoxin
seminar San Francisco
Process Analytical Technology
PAT
process validation
Steven S Kuwahara
online training
ISO 14971
Risk Management for Compliance
Proper Documentation
FMEA
Factors regulatory
risk management tools
standards compliance
online training
Curtailing Microbial Excursions
Pharmaceutical Water Systems
Water system dilemma
outlet flushing
online training
Water System Biofilm Control
Microbial Monitoring Myths
c-GMPs
Microbial Enumeration Myths
TOC
Microbial Count Correlates
online training
Device Changes
510(k)
U.S. FDA device clearance
EU's emphasis
FDA Decision Tree
K-97-1
online training
DHF
DMR
DHR
Technical File
Design Dossier
EU's MDD
TF or DD Expected Contents
NB Audit Focus
online training
Validation of Analytical Methods
FDA Compliance
USP Chapters
ICH Guides
FDA regulations
SOP for method validation
online training
Clean Room Qualification and Operation
Interlocks and Pass Throughs
clinical
QA
india seminars
GMP
CGMP Requirements
Streamlining Quality Assurance
FDA Compliance
US Drug Regulation
CAPA
DMF
NDA and BLA
ICH Q8
Q9
and Q10
online training
Risk Assessment
Compliance
hazard analysis
Traceability
establish mitigations
online training
Risk Management
Design Validation
process Validation
regulatory requirements
validation plan
validation protocol
online training
Manufacturing Contamination Control
microbiology lab
ontamination control support
contamination correlations
online training
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Medical Device Supplier Quality Agreements
Quality System Regulation
QSIT
13485 2003
FDA Quality System Inspection Technique
Warning Letters
online training
Residual Moisture Testing
Lyophilized Products
Gravimetric methods
dried products
Volumetric Karl Fischer titration
CoulometricKark Fischer titration
online training
Lyophilized Products
Lyophilization cycle
freeze-dryers
Dryer configuration
choked flow conditions
Scale-up strategy
online training
Postmarketing Vigilance Reporting
MEDDEVs
Global Harmonization Task Force
European vigilance system
online training
Bullet Proof 510(k)
FDA
risk device
De Novo process
Quality System
21 CFR 807
Submission Methods
online training
Corrective and Preventive Actions
CAPA
ISO and regulatory agencies
CAPA process
online training
Market Corrections in Compliance
FDA
ISO Requirements
QSR
Regulatory
ISO 13485-specific requirements
CMD-specific requirements
online training
Lean-Agile Project Management
cGMP Environment
FDA
Formal Project Management
Gantt
CPM
PERT
Failing Fast
india seminars
GMP and Regulatory Expectations
IND Products
regulations and guidelines
R & D activities
GLP requirements
Animal Rule and Orphan Drugs
Steven Kuwahara
Mitigation architectures
Residual risk
Hazard domains
Risk Management Medical Devices Industry
Markus Weber
india seminars
System validation
mitigation validation
india seminars
Risk Management
Pharmaceutical Industry
QRM
Risk Identification
QRM Tools
QRM
QMS
QRM Audit
Computer System Validation
21 CFR Part 11
avoid 483s
Spreadsheet Validation
seminar San Francisco
Compliance for Electronic Records
Signatures
FDA Draft Guidance
Risk Based Approach
Compliance Training
Clinical Investigation
Good ClinicalPractices
ICHE6 guidelines
CFR 21 Part 11
tag along audits
FDA
ERES
RAC recertification
Warning Letters
IEC 62304
Medical Device Software Development
software lifecycle standard
requirements specification
integration testing
real-time systems
FDA Inspection Process
SOP to 483
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FDA guidance documents
Regulatory Management
Statistical Pitfalls
Method Validation
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API
CMO
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testing protocols.
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Documentation
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Software Validation
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audit trails.
CAPA
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Quality Tools
Team Effectiveness
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problem solving tools
management tools.
Receipt to Trending
Management
closed-loop investigations
investigations
product complaint management system.
21 CFR Part 11
EU Annex 11
FDA's New Enforcement Practices
DHF
DMR
DHR
Lean Documents
Lean Configuration
Quality System Regulation
online training
Water System Validation
insurance policy
Micro Test Method
honeymoon
online Training
GXP requirementsTMF
DMF
Regulatory chronology
Regulatory master files
GMP documents
online training
Regulatory Complaint
MDR's & Recalls
FDA's Complaint
Part 803
Medical Device Reporting
Part 806
Warning letters
online training
Benchmark validation
Sterilization
kinetics of lethality Pre-validation
Post-validation
sterilization validation
online Training
cleanroom cleaning methods
Controlled Environments
cleanroom management.
online training
Drug Development Process
R&D
Commercialization
Pre-clinical studies
Drug Commercialization
Code of Federal Regulations
ICH.
online training
GMP Phase 1 Products
21 CFR 211
types of phase 1 products
Regulatory Affairs
Quality control
online training
Validating Excel
EU MDD Software V&V Expectations
Risk Allocation of Scarce Resources
Warning Letters indicating
online Training
483 Warning Letters
FDA Inspections
Form 483 audit
Remediation
online training
Software Validation
21 CFR Part 11
GAMP
SOPs
electronic signatures
avoid 483
Warning Letters
online training
CE Marking
Vitro Diagnostic Devices
European Union
EU
MDD
AIMDD
IVDD
online training
Pharmacovigilance Practices
Marketing Authorization Holders
Pharmacovigilance Risk Assessment
Drug Reaction Reporting.
online training
Hazard Analysis
FMECA
Probabilistic approaches
design process
documentation formats
Regulatory
online training
Life Sciences manufacturing
Lean Documents
Lean Configuration
QMS
Quality Management System
21 CFR Part 820
ISO 13485
online Training
Behavior in Cleanrooms
Controlled Environments
cleanroom contaminants
online training
Navigating
510(k)
PMA Submission
IDE
Approval Process
Substantial Equivalence
Predicates
PMA.
online training
Pharmaceutical Filings
Registration Procedures in EU
Clinical Trial Directive
GCP
GMP
EU Licensing Plan
EUCTD
ICH compliant
online Training
Clinical Management Systems
CTMS
General Principles of Software ValidationQuality Management System
online training
Tumor Bioenergetics
Lab Bench
Clinical Trials
FDA Guidelines
FDA regulation
nanotechnology
cancer chemotherapeutics
online training
Excel Spreadsheets
Regulated Environments
HIPAA
Sarbanes Oxley Act
FDA's GxP
21 CFR Part 11
ad hoc spreadsheet
online training
Water System Sanitization
Purified Water systems
Purified Water systems
microbial control measures
online Training
CDRH
21 CFR 11 compliance Validated Computerized System
Project Management
online training
Device Corrections
Part 806 FDA
QSIT inspection
Removal under Part 806
potential 510k submissions
draft guidance
online training
Adverse Event
Medical device manufacturers
Medical device vigilance
Report adverse events
online training
Management Controls
QSR
ISO 13485
internal audit program
quality plan
FDA
Quality System
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HIPAA Privacy Rule Principles
Breach Notification Compliance
HIPAA Audits
HIPAA Regulations
HIPAA Compliance
Risk Management
ISO14971
IEC62304
IEC60601
FDA compliance issues
Mitigation Risk
Hazard Source
510K submissions
510k Premarket submissions
CDRH
FDA
Preamendment Devices
FDA Guidance Documents
predicate device
FDA Trends
Regulatory Compliance
Dietary Supplements
FDA Structure
FTC jurisdiction
Labeling Considerations
GMP compliance
Microbial Control
Pharmaceutical Water Systems
Microbial Validation
Microbial Troubleshooting
Water System Validation
Controlling Endotoxin
online training
Postmarketing Vigilance Reporting
MEDDEVs
Global Harmonization Task Force
European vigilance system
online training
Water System Investigation
Case Studies
product contaminations
kernels of water system
Recognizing red herrings
online training
FDA BIMO Inspection
GLP
GCP
Good Laboratory Practice
Good Clinical Practice
ICH GCP guidelines
online training
Statistical Procedures
Compliance
Process Validation
FDA
validation reports
Quality assurance
Auditors
online training
Alligator Farm
Root Cause Analysis
RCA
Shutting Alligator Farm
online training
Life Science Products
Clinical Trials
Supply Chain Considerations
Regulatory Structure in China
online Training
QSIT
closed-loop CAPA
FDA cGMP compliance
compliance / enforcement
online Training
EU Medical Device
EU Council Directive 93/42/EC
EU
online Training
cGMP Regulations
cGMP Inspections
QMS
FDAs cGMP regulationsSix Systems Inspection Model
online Training
Validation Master Plan
VMP
creation of vmp
implementation of vmp
online Training
Six Sigma DMAIC
CAPA
Design History Files
DHF
Device Master Records
DMR
Device History Records
DHR
online training
Hazard Analysis
IEC60601
ISO14971
hazard evaluation strategies
online Training
development of Therapeutics
Companion diagnostic
draft guidance
FDA
online Training
complaint handling system
CAPA
QSR and ISO 13485
investigation complaint handling
online Training
21 CFR Part 11
FDA Inspection
Part 11 inspections
Part 11 regulation
online training
Device Identifier
Device Manufacturers
unique device identification
medical device identification
UDIs
National Drug Code
online Training
EU regulations
regulatory expectation
deviation management process
online Training
EU regulations
regulatory expectation
deviation management process
online Training
FDA Guidance
Clinical Trials for Foods
Dietary Supplements
online Training
Dos and Donts of FDA
FDA inspection
SOP for FDA inspection
online training
Water System Biofilm Control
Microbial Monitoring Myths
c-GMPs
Microbial Enumeration Myths
TOC
Microbial Count Correlates
online training
Successful 510k submission
FD&C Act or the Act
510k premarket submission
PMA
21 CFR 807
online training
ISO 13485
Operational Qualification
OQ
ISO 14971
Statistical Concepts
Risk Management
Quality Control Assurance
QCA
pharmaceutical quality systems
FDA
statistics for qca
india seminars
Microbial Control
Pharmaceutical Water Systems
Water System Validation
Validated System
Water Microbial Excursions
Endotoxin
Online Training
Construct
Manage
Design Dossier
CE Mark
Medical Device Directive
Online Training
Pharmaceutical
Biologics Facility Design
FDA
Regulatory Aspects
/index.php/myinterest/network/tagid/7412
Online Training
21 CFR Part 11
Predicate RuleComplying
Part 11 Regulation
Online Training
Clean Room
Operation
Aspects
Acceptance Criteria
Online Training
Key Factors
SOP
Work Instructions
FDA
RAC recertification
Online Training
Pharmaceutical
Water System
Chemical testing
Online Training
Avoiding
FDA Warning
CAPA Program
Quality System Regulation
Online Training
Design History File (DHF)
Device Master Record (DMR)
Technical File (TF)
FDA
OEM relationships
Online Training
Investigational
IMPD
EU CTA
FDA IND
Agency ExpectationsFDA
Online Training
Investigational
IMPD
EU CTA
FDA IND
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Online Training
Design
Control
CE marking
Design plans
FDA's design regulations
Validation
Verification
Online Training
Implementing
Medical Device
Handling Systems
CAPA(s)
Complaint
Online Training
DHF
DMR
DHR
Design Dossier
USFDA
EU MDD Requirements
Online Training
/index.php/myinterest/network/tagid/7477
Management
US FDA
EU
RAPS
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FDA's
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Introduction
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regulatory
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Statistical Procedures
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FDA
validation reports
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Lyophilization
Process Development
Cycle Design
DSC
FDM
freezing
primary
Online Training
Process Validation
Protocols
Medical Devices
IQ
OQ
PQ
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Process Validation
Protocols
Medical Devices
IQ
OQ
PQ
online Training
FDA Guidance
Clinical Trials for Foods
Dietary Supplements
Online Training
Device Exemption
FDA Investigational
21 CFR 812
Research
Medical Device
Add-On Inspections
FDA Requirements
CSV
computer systems validation
21 CFR 11
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Records Management
FDA Records
Creating RFPs
RAPS
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Deviation Practice
CAPA processes
Quality System
regulatory
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Dos and Donts of FDA
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online regulatory compliance
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Ensuring Integrity
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/index.php/myinterest/network/tagid/7562
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standards
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FDA QSR
ISO 13485
Cost-Effective
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21 CFR Part 11
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Preparation
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Change Control
cGMP Compliance
Document Control
Filing a New 510
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Excel Spreadsheets
Compliance
21 CFR Part 11
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warning letters
regulatory inspection
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Root Cause Analysis
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System Thinking
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regulatory requirements
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Recalls
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Complaint Handling
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FDA 483s
FDA regarding
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recent FDA 483s
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documentation
21 CFR 11
computer systems validation
CSV
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Compliance Training
regulatory training
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compliance training
Device History File
Iso 13485
Medical Compliance
Fda Guidance
compliance webinar
Good Documentation Practices
Iso 13485 Design
Sox Compliance Training
Design History File
C
US Seminars
US Conference
2013 Pharma Seminar Mastering Biofilm Control
Pharmaceutical Water Systems
USP
Conferences and Seminars
San Francisco Seminar
Compliance Training
microbial test
US Seminars
US Conference
Conferences and Seminars
Compliance Training
Washington Seminars
Excel Spreadsheet Training
David Nettleton Seminars
computer systems validation
Validation Plan
Software Validation
India Seminar
Mumbai Seminar
New FDA Inspections
Lalit Hotel Seminar
Mumbai Conferences
Mumbai Seminar 2013
HIPAA Seminar
21 CFR Part 11 Seminar
Computer System Validation
health care reforms
health care
health
US Seminars
US Conference
Conferences and Seminars
Compliance Training
Los Angeles
Statistics Seminars
Steven Walfish Seminars
Medical Device Training
Statistical Process Control
US Seminars
US Conference
Conferences and Seminars
Compliance Training
David R. Dills Seminars
Boston Seminars
computer systems validation
FDA Requirements
Add-On Inspections
Risk Assessment
US Seminars
US Conference
Conferences and Seminars
Compliance Training
21 CFR 11
San Diego Seminars
practical Risk Management
ISO 14971
IEC 62304
FDA Requirements
Add-On Inspections
US Seminars
US Conference
Conferences and Seminars
Compliance Training
Chicago Seminars
HIPAA Privacy
HIPAA Security
HIPAA compliance
FDA Regulations
Jim Sheldon Dean
HIPAA Regulations
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