- Freelancer services
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- Recorded Webinar: Construct and Manage the Technical File and Design Dossier
- Recorded Webinar: DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
- Recorded Webinar: The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND
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- Generic Pharmaceuticals
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- Innovative Pharmaceuticals
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- Readability User Testing (RUT) in Croatia
- Reformating CTD Dossier from pdf to NeeS or eCTD format
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- ISO Training
- Recorded Webinar: Better Alternatives to Sampling Plans
- Recorded Webinar: ISO 13485: 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation
- Recorded Webinar: CAPA - Current Expectation of ISO 13485 and FDA Auditors
- Recorded Webinar: Introduction to SPC (Statistical Process Control)
- Medical Device
- Recorded webinar - Management Review: The Complete Requirements
- Recorded Webinar: 21CFR Part 58 - The Good Laboratory Practices (GLP) Regulation
- Recorded Webinar: Biocompatibility Testing of Medical Devices in the US and Use of ISO-10993
- Recorded Webinar: Designing Alarms in medical Devices to Address the Hospital Concerns
- Recorded Webinar: Laboratory-Developed Tests: Why does FDA think they can regulate them, and why do others think they cannot
- Recorded Webinar: Medical Device Design Control
- Recorded Webinar: Medical Device Supplier Quality Agreements
- Recorded Webinar: New Requirements for the Medical Device Directive (MDD)
- Recorded Webinar: U.S. FDA's Strategic Priorities for 2013 and Beyond
- Recorded Webinar: Webinar on Medical Device Tracking
- Recorded Webinar: 21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
- Recorded Webinar: 510(k): Format and Contents
- Recorded Webinar: Batch Production Record and Device History Record Review and Quality Assessment
- Recorded Webinar: CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
- Recorded Webinar: Cleaning Validations Using Extraction Techniques
- Recorded Webinar: Compiling the Design History File, and Technical File / Design Dossier
- Recorded Webinar: Current Good Manufacturing Practice for Medical Devices Including IVDs
- Recorded Webinar: Design Controls - Requirements for Medical Device Developers
- Recorded Webinar: Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration
- Recorded Webinar: Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements
- Recorded Webinar: Designing Medical Devices with Cleanliness in Mind
- Recorded Webinar: Device Changes, FDA Changes, and the 510(k)
- Recorded Webinar: Device Corrections and Removals
- Recorded Webinar: Device Master Record & Device History Record
- Recorded Webinar: Human Behavior in Cleanrooms and Controlled Environments
- Recorded Webinar: IEC 62304 for Medical Device Software Development: Steps to Compliance
- Recorded Webinar: Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
- Recorded Webinar: Key Concepts to Develop and Manage your MDR Program
- Recorded Webinar: Medical Device Complaint Handling Systems
- Recorded Webinar: Medical Device Complaint Handling Systems
- Recorded Webinar: Medical Device Complaint Handling: MDR, Reports of Removals and Corrections
- Recorded Webinar: Meet the U.S. FDA's Tougher Requirements for the 510(k)
- Recorded Webinar: Mobile Medical Applications: Trends and Regulations in US & Globally
- Recorded Webinar: Obtaining an FDA Investigational Device Exemption
- Recorded Webinar: Practical Water System Design and Operation Issues Impacting Biofilm Control
- Recorded Webinar: Process Validation Principles and Protocols for Medical Devices
- Recorded Webinar: Purchasing and Supplier Controls in the Medical Device Industry
- Recorded Webinar: Regulatory Complaint Handling, MDR's & Recalls
- Recorded Webinar: Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
- Recorded Webinar: The FDA Electronic Submission Gateway (ESG)
- Recorded Webinar: Tougher FDA cGMP Compliance Audits and Enforcement
- Recorded Webinar: Unique Device Identification (UDI): Upcoming FDA Rules, Requirements and Timelines for Industry and Hospitals
- Recorded Webinar: Water System Investigation "How-To's" and Example Case Studies
- Meetings with Authorities
- Recorded Webinar: FDA's 21 CFR 11 Add-On Inspections - Recent Updates
- Recorded Webinar: How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
- Recorded Webinar: Meeting FDA requirements for OTC Drug Labeling
- Recorded Webinar: 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection
- Recorded Webinar: Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations
- Recorded Webinar: Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process
- Recorded Webinar: Current Companion Diagnostic Regulatory Framework in the EU & US
- Recorded Webinar: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
- Recorded Webinar: FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
- Recorded Webinar: Meeting Annual U.S. FDA CGMP Training Requirements
- Recorded Webinar: Prepare for Tougher cGMP Compliance Audits
- Recorded Webinar: Responding to FDA 483's
- National market access support
- National pharmacovigilance
- Periodic Safety Update Reports
- Phase I clinical study
- Recorded Webinar: Electronic Informed Consent for Clinical Trials: Why, What and How
- Recorded Webinar: ICH GCPs and the Clinical Research Process (Including Phase 0,1,2,3 and Phase 4 trials)
- Recorded Webinar: Project Management for Phase l & ll Clinical Trials
- Recorded Webinar: Good Documentation Practices for Clinical Trials and Studies
- Recorded Webinar: South Korea: Navigating the Clinical Trial and Regulatory Environment
- Project Management
- QA Policy Development
- Local Audits in Croatia, Serbia, Bosnia & Herzegovina
- Recorded Webinar: CAPA Challenges and FDA Expectations
- Recorded Webinar: Complaint Handling and Management: From Receipt to Trending
- Recorded Webinar: Meet FDA Expectations for a Tougher Supplier Audit Program
- Recorded Webinar: Understanding Analytical Test Results: Comparing Two Sets of Data
- Recorded Webinar: Webinar on Specification Mapping
- Recorded Webinar: 21 CFR Part 11: Complying with Part 11 Regulation - Understanding the Predicate Rule
- Recorded Webinar: Bullet-Proof CAPA
- Recorded Webinar: Change Control - The Achilles Heel of cGMP Compliance
- Recorded Webinar: Clean room Design, Certification & Validation
- Recorded Webinar: Common Sense Water System Validation
- Recorded Webinar: Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean Documents and Lean Configuration
- Recorded Webinar: Current Concepts & Challenges in Cloud Compliance
- Recorded Webinar: Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
- Recorded Webinar: Deviation Management System
- Recorded Webinar: Disinfection and Clean room Cleaning in a FDA Regulated Environment
- Recorded Webinar: Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner
- Recorded Webinar: Effective and Compliant Change Control Management - Before, During and After Validation
- Recorded Webinar: Facilities Cleaning in Cleanrooms and Controlled Environments
- Recorded Webinar: FDA Guidance Regarding Software Validation for Clinical Trial Management Systems
- Recorded Webinar: Fundamentals of Process Validation
- Recorded Webinar: GMP Perspectives on Working with Contracting Laboratories
- Recorded Webinar: Good Deviation Practice: what you need to know
- Recorded Webinar: Good Documentation Practices for GMP Operations
- Recorded Webinar: IEC62304 - Development and Maintenance of Critical Software
- Recorded Webinar: Key Concepts in Successful Water System Sanitization
- Recorded Webinar: Key Factors to Improve Regulatory Information Management Policies and Procedures
- Recorded Webinar: Laboratory Water Systems: Necessary Water Specifications and Validation Challenges
- Recorded Webinar: Lyophilization Process Development and Cycle Design with a Case Study
- Recorded Webinar: Software Verification and Validation Planning and Documentation
- Recorded Webinar: Statistical Procedures Needed for Compliance with the Guidance on Process Validation
- Recorded Webinar: The Master Validation Plan - The Unwritten Requirements
- Recorded Webinar: Validation and Use of Excel® Spreadsheets in Regulated Environments
- Recorded Webinar: Water System Biofilm Control and Microbial Monitoring Myths
- Qualified Person for BR
- Readability User Testing
- Regulatory submissions
- Recorded Webinar: Auditing Analytical Laboratories for FDA Compliance
- Recorded Webinar: Biosimilar (Generic) Biologics In The USA: Approval Pathway
- Recorded Webinar: Excel Spreadsheets and FDA Device Regulations
- Recorded Webinar: FDA Regulation of Medical Devices : Rules, Expectations and Needed Submissions
- Recorded Webinar: FDA's New Enforcement of 21 CFR Part 11
- Recorded Webinar: GMP for Phase 1 Products
- Recorded Webinar: Good Documentation Practices in a Regulated Environment
- Recorded Webinar: Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
- Recorded Webinar: U.S. FDA's Strategic Priorities - 2014 and Beyond
- Recorded Webinar: Avoiding Statistical Pitfalls during Method Validation
- Recorded Webinar: Biopharmaceutics vs. Medical Devices: Similarities and Differences in the FDA Regulatory Paths
- Recorded Webinar: Bullet-Proof Closed-Loop CAPA
- Recorded Webinar: Calibration and Qualification in Analytical Laboratories
- Recorded Webinar: Change Control - Key to Successful cGMP Compliance
- Recorded Webinar: Change Control and Configuration Management for Computer Systems
- Recorded Webinar: China: Compliance Processes for Life Science Products: Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations
- Recorded Webinar: Clinical Trial Applications in Canada, and Comparison to the US and Europe
- Recorded Webinar: Comparison of GCP, GLP and GMP; FDA's Three Major Regulation
- Recorded Webinar: Computer System Validation: Step-by-Step
- Recorded Webinar: DHF, DMR, DHR and TF - Regulatory Documents Explained
- Recorded Webinar: Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner
- Recorded Webinar: Effective Training Practices for FDA Compliance
- Recorded Webinar: Ensuring Integrity and Security of Electronic Records for FDA Compliance
- Recorded Webinar: Establish and Maintain an Effective Supplier Qualification Program
- Recorded Webinar: FDA 483 Observations in the Laboratory. What went wrong? How can they be avoided?
- Recorded Webinar: FDA Acceptance of Foreign Clinical Studies Not Conducted Under An IND
- Recorded Webinar: FDA Inspections - Do's and Don'ts
- Recorded Webinar: FDA Inspections - How Investigators Typically Process the Results
- Recorded Webinar: FDA's New Breakthrough Therapy Designation Program and Other FDA Expedited Programs
- Recorded Webinar: FDA-Compliant Medical Device Reporting (MDR)
- Recorded Webinar: FDA’s Enforcements for Mobile Medical Applications
- Recorded Webinar: Good Documentation Practice for GxP Environments
- Recorded Webinar: Good Documentation Practices for Laboratory Operations
- Recorded Webinar: Good Laboratory Practice Regulations - Introduction and Strategies for Implementation
- Recorded Webinar: How to Bullet Proof your Documents from Most Commonly Cited GDP Violations
- Recorded Webinar: How to Prepare for a Tag Along Audit of CFR 21 Part 11
- Recorded Webinar: How to Prepare for, Manage, and Follow-up to an FDA Inspection
- Recorded Webinar: How to Select Software for a Regulated Environment
- Recorded Webinar: How to submit a 510(k) and get it cleared from FDA
- Recorded Webinar: Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
- Recorded Webinar: Lipid Based Formulations and Targeting Tumors - FDA Considerations of Nanotechnology in Drug Manufacturing, Drug Delivery and Drug Products
- Recorded Webinar: Medical Device Adverse Event Reporting in EU, US and Canada
- Recorded Webinar: Medical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers
- Recorded Webinar: Navigating the 510(k), IDE and PMA Submission and Approval Process
- Recorded Webinar: Outsourced processes and ISO 9001:2008
- Recorded Webinar: Outsourcing Management - Effective Contract Manufacturers, Supplier Evaluation, Approval and Monitoring
- Recorded Webinar: Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
- Recorded Webinar: Pharmaceutical Manufacturing Batch Record Review
- Recorded Webinar: Process Validation to Meet U.S. FDA Requirements
- Recorded Webinar: Quality System Regulations for Medical Devices and In Vitro Diagnostic Devices
- Recorded Webinar: Setting Up and Running a Tougher Supplier Audit Program
- Recorded Webinar: Statistics for Quality Control and Process Validation: Basic Factorial Designs
- Recorded Webinar: Statistics for Quality Control and Process Validation: Statistical Process Control (SPC) for Attribute Data
- Recorded Webinar: Statistics for Quality Control and Process Validation: Statistical Process Control (SPC) for Variable Data
- Recorded Webinar: Strategic Importing of FDA Regulated Products
- Recorded Webinar: Successful 510(k) submission: Contents and Format
- Recorded Webinar: Supplier and Internal Auditing
- Recorded Webinar: The 510(k) Submission: Requirements, Contents, and Options
- Recorded Webinar: The FDA Inspection Process
- Recorded Webinar: The U.S. FDA's Tougher Supplier Controls
- Recorded Webinar: Using Statistical Methods for Effective Outlier Detection
- Recorded Webinar: Using Statistics to Determine Sample Size
- Recorded Webinar: Validating Excel and Word
- Recorded Webinar: Validation Master Planning and Regulatory Expectations
- Validation of Bioanalytical Methods and Procedures for FDA Compliance
- Risk Managment Plan
- Recorded Webinar: A CAPA Primer - Elements of a CAPA Program and Uses of CAPA Data
- Recorded Webinar: FDA Device Software Regulation
- Recorded Webinar: Leadership in Manufacturing Contamination Control
- Recorded Webinar: Risk Management for Medical Devices - ISO 14971
- Recorded Webinar: Statistical Concepts of Process Validation
- Recorded Webinar: 21 CFR Part 11 - Compliance for Electronic Records and Signatures
- Recorded Webinar: Auditing a Validation Program - a Risk-Based Approach
- Recorded Webinar: Avoiding FDA Warning Letters with a Strong CAPA Program
- Recorded Webinar: CAPA - The Heart of Your Quality System
- Recorded Webinar: Creating Effective Master Validation Plans
- Recorded Webinar: Development and Audit of Complaint Handling and MDR Processes
- Recorded Webinar: Effective Application of CAPA using a Risk-Based Approach
- Recorded Webinar: EU Medical Device Classification
- Recorded Webinar: Introduction to ISO 14971: Risk Management
- Recorded Webinar: Leadership in Manufacturing Contamination Control
- Recorded Webinar: Master V&V Planning to Meet FDA, ISO 13485 and 14971:2009 Requirements
- Recorded Webinar: Medical Device Cleanliness: When and How to adjust LIMIT VALUES
- Recorded Webinar: Risk-based Software Verification and Validation
- Recorded Webinar: Root Cause Analysis: Key to an Effective CAPA System
- Recorded Webinar: Statistical Process Control and Trending Analysis
- Recorded Webinar: Understanding the New USP Chapter 1224 for Transfer of Analytical Methods
- Recorded Webinar: Webinar on Supplier Risk Management
- Scientific advice
- Social Media Communications
- Translations
- Validated PV database
- Validation Protocol Development
- Recorded Webinar: 2011 FDA Guideline on Process Validation
- Recorded Webinar: Equipment Validation, Tracking, Calibration, and Preventive Maintenance
- Recorded Webinar: FDA Inspections: What to Expect and How to Prepare
- Recorded Webinar: Understanding and Preparing for FDA's on-going Part 11 Inspection Program
- Freelancer projects
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- Regulatory Affairs Support Required in Turkmenistan
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- National market access support
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