Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings Seminar training classes conferences & workshops presented by ComplianceOnline register for training on FindaSeminar.com

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Training Course Syllabus:

Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.

In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.

Learning Objectives:

Seminar Summary:

In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors. (see full course description)

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•  ACCOUNTING
  • Accounting and Bookkeeping Best Practices: 2-Day Workshop
•  Compliance
  • 21 CFR (Código de Regulamentos Federais) Parte 11 conformidade para a validação de software e SaaS (Software como Serviço)/Cloud
  • 21 CFR Part 11 Compliance for SaaS/Cloud Applications
  • 21 CFR Part 11/Annex 11 compliance for software validation and SaaS: In-person Seminar
  • 4th Annual ComplianceOnline Medical Device Summit 2018
  • A Comprehensive View of FDA Regulations for Medical Devices: 2 - Day In-Person Seminar
  • A risk based approach to GxP Compliant Laboratory Computerized Systems
  • A Risk Based Scientific Approach to Analytical Methods Development and Validation Activities for FDA Regulated Industries
  • Account Payable Best Practices: One and a Half Day In-Person Seminar
  • Accounts Receivable/Consumer Debt Collection - From Delinquency to Bankruptcy
  • ACH Risk Management: 2-day Workshop
  • Advanced Risk Management Seminar – Maximising Value from Your Organization’s Investment in Risk Management
  • Advertising and Promotion of Dietary Supplements: 2-Day In-Person Seminar by Ex-FDA Official
  • Aerospace Program Management - It's More than Scheduling and Delivery
  • AML/BSA Boot Camp
  • Analytical Instrument Qualification and System Validation
  • Analytical Methods in Development and Manufacture of Drugs and Biologics
  • Analyze Safety In The Workplace:  Inspections, Management Techniques & Training Methods: In-person Seminar
  • Applications of Statistics to Pharmaceutical Operations with Explanatory Statistics and Sampling Software
  • Applied Statistics for Scientists and Engineers
  • Applying ISO14971 / IEC62304 / IEC62366-1 - A Practical Guide On How To Implement Risk Management
  • Aseptic Processing Overview and Validation: 2-Day In-Person Seminar
  • Associate in Human Resources Generalist Certificate Program
  • Auditing for Medical Device and Pharma Companies
  • Australian Regulatory Guidelines for Medical Devices (ARGMD): Government Reimbursement, Requirements, Fees and Turnaround Time to Product Approval: 2-Day Workshop
  • Bad Things Happen, But It Can Get Worse - Understanding FDA Post Market Regulations
  • Behavioral Based Safety and OSHA 10-HR General Industry Outreach Course
  • Best in Class Wage & Hour Compliance: The Federal Labor Standards Act (FLSA)
  • Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices
  • Bioanalytical Methods and Good Laboratory Practices (GLP) - Essential Elements for Pre-Clinical Studies during development of Drugs
  • Biocompatibility Testing for Medical Devices
  • Biopharmaceutical Test Method, Methods from Cradle to Grave - Technical, Regulatory & Business Considerations
  • Biostatistics for the Non-Statistician: 2-Day In-Person Seminar
  • BSA/AML/OFAC Risk Assessments - Are You Doing Them Correctly
  • Building a Fair and Equitable Pay Program – 3-Day In-person Seminar
  • Building a Vendor Qualification Program for FDA Regulated Industries: One and Half Day In-Person Seminar
  • Business Continuity Auditing Plans Using ISO 22301
  • CA&PA for Medical Devices
  • Case Management Boot Camp: Best Practice Strategies For Success
  • Case Management Boot Camp: Strategies for Success in the Acute Care Setting and Beyond!
  • CDISC Mapping and Strategies Implemented: 2-Day In-person Seminar
  • CGMP Quality Principles for the FDA Regulated Industries: 2-Day In-Person Seminar
  • Change Control Best Practices - Avoiding Unintended Consequences of Changes: 2-Day In-Person Seminar
  • China & Pacific Rim Markets : Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations
  • CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA
  • Common Compliance Issues in a Quality Control Laboratory - Data Integrity, Out of Specifications (OOS), Corrective and Preventive Actions (CAPA)
  • Complete 1099, TIN Matching, B-Notice, FATCA and Nonresident Alien 1042-S Compliance Update: 2-Day In-Person Seminar
  • Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
  • ComplianceOnline Pharma Summit 2016 – Risk Control and Compliance
  • Computer System Validation - Reduce Costs and Avoid 483s
  • Confined Spaces for General Industry. Lockout/Tagout
  • Confined Spaces in Construction. Silica in Construction
  • Corrective and Preventative Action Topics: Investigation Phase, Action Phase and Verification of Effectiveness Phase
  • COSO Framework for Internal Controls, Risk Assessment and Financial Statement Audit: 2-Day In-Person Seminar
  • Creating Reader-Focused Technical Documents in FDA Regulated Industries
  • Criminal Background Checks in the Hiring Process - What Every Employer Needs to Know -EEOC, FCRA, FACTA & Negligent Hiring and Vicarious Liability
  • Critical Vendor Risk Management
  • Cyber Security Incident Response Program (CSIRT) and Plans
  • Data Breaches, Cyberfraud, Identity Theft and Associated Frauds: 2-Day In-Person Seminar
  • Data Integrity, Good Documentation Practices and Electronic Data Governance
  • Data Integrity: FDA, WHO and EMA's Requirements: 2-Day In-person Seminar
  • Data Integrity: FDA/EMA Requirements and Implementation
  • Data Integrity: FDA/EU Requirements and Implementation
  • Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration
  • Designing and Sustaining New and Existing Product Stability Testing Program
  • Detecting and Preventing Internal and External Fraud
  • Developing Documents and Records to meet the Requirement of ISO 17025
  • Drug Dissolution Testing and Establishing Plasma Drug Levels in Humans
  • Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation
  • eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
  • Effective Design, Validation and Routine Maintenance of Pharmaceutical Gases: 2-Day In-Person Seminar
  • Effective Design, Validation and Routine Maintenance of Pharmaceutical Water
  • Effective Financial Compliance: How to Defend SEC and Financial Regulatory Enforcement Actions and Examinations: 2-Day Workshop by Former SEC Inspector
  • Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
  • Effective Risk Management Strategies for the Department and the Enterprise
  • Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues
  • Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices
  • Employment Laws Certificate Program: 2 Days in person Seminar
  • Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices: 2-day In-person Seminar
  • Essential Skills Crash Course for the HR Professional: 3-Day Certification Program
  • Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters: 2-Day In-Person Seminar
  • Expense Reporting Best Practices: One and a Half Day In-Person Seminar
  • Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2018/2019)
  • FDA Audit, Quality Assurance Practices, Responsibilities and Expectations
  • FDA Compliance and Clinical Trial Computer System Validation: 2-Day In-person Seminar
  • FDA Import, Export and Foreign Operations for Medical Devices and Pharmaceuticals: 2-Day Workshop
  • FDA Penalties for Non-Compliance in Pharma - 2017 case studies and Readiness for 2018
  • FDA Recalls - Before You Start, and After You Finish
  • FDA Regulations for Dietary Supplements Manufacturers (21 CFR Part 111, GMP and QMS)
  • FDA Requirements for Food Defense Planning and Implementation
  • FDA Scrutiny of Promotion and Advertising Practices
  • FDA Scrutiny of Purchasing/Supplier Controls
  • FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
  • FDA's Import Program for 2016 - New Pathways and Pitfalls: 2-Day In-Person Seminar by Ex-FDA Official
  • FDA's Medical Device Software Regulation Strategy
  • FDA's New Import Program for 2019 - Strict Precision
  • FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy
  • FDA's Regulation of Implantable and Wearable Sensors: 2-Day In-Person Seminar
  • FMLA and ADA Compliance Certificate Program: Everything You Ever Wanted to Know
  • FMLA, ADA and PDA Certificate Program : 2-Day In-Person Seminar
  • Focus Four Construction: Top 4 Life Critical Safety Issues to Avoid
  • Food labelling and advertising requirements for foods sold in Australia and New Zealand
  • Food Safety and Defense: Key Factors to Safely Manufacture, Package and Handle Food Products
  • Forensic Auditing: 2-Day Workshop
  • Fostering Employee Engagement
  • Fundamentals of Operational Risk Management - from Assessment to Implementation
  • GMP Compliance for Quality Control and Contract Laboratories : 2-Day In-Person Seminar by Ex-FDA Director
  • Good Corporate Governance: 2-day Workshop
  • Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
  • Healthcare Privacy and Security Regulations: Satisfying HIPAA, GDPR, 42 CFR Part 2, FERPA, and State Laws Protecting Health Information
  • HIPAA - The Requirements for a Compliance Program
  • HIPAA - Time to get Serious
  • HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
  • HIPAA Security and Breach Rule Compliance- Understanding Risk Analysis, Policies and Procedures and Managing Incidents
  • How to apply ISO 62304 standard in a medical software development project?
  • How to build and validate Excel spreadsheets for GxP compliance
  • How to Conduct a Workplace Harassment, Bullying & Violence Investigations Training
  • How to Create Excel Dashboards Using Pivot Tables: In-Person Seminar
  • How to Develop an Effective Enterprise Risk Management Program
  • How to Implement a Quality Management System According ISO 13485?
  • How to Minimize FCPA Exposure and Conduct Comprehensive Internal Investigations
  • How to Navigate and Manage Employee Leave Issues under the FMLA, ADA and Workers' Comp Laws
  • How to Pass the Customs Broker Exam
  • How to Perform a Cognitive Load Assessment for Human Error Reduction: 2-Day In-Person Seminar
  • How to prepare a 510(k) Notification and a Technical File for the CE Mark
  • How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings
  • How to Write Error Free Procedures and Instructions: 2-Day In-Person Seminar
  • HR Metrics and Analytics 2019
  • Human Error Reduction Program: How to investigate, predict, prevent, correct & recover from Human Error in the manufacturing floor and GMP environments
  • Human Factors and Predicate Combination Products
  • Human Resource Essentials - HR Compliance Certification Program
  • Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11: 2-Day In-Person Seminar
  • Implementing an Effective Regulatory and Policy Change Management Process: 2-Day Workshop
  • Incorporating Risk Management in your HR policy
  • Insurance Fraud Investigation: 2-Day Workshop
  • Integration of Human Factors into Medical Device Design: FDA and European Commission - 2-Day In-person Seminar
  • Internal Audit, Fraud Risk Assessment and Risk Management Annual Plan
  • Internal Controls to Detect and Prevent Corporate Fraud: 2-day Workshop
  • International Trade Finance
  • Introduction to Antimicrobials in Veterinary Medicine
  • Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings
  • Is your Medical Device Software 510(k) Ready?
  • ISO 13485, ISO 14971, Quality Document Management, and Risk Management for Medical Devices
  • Keeping Secrets beyond HIPAA: How to Maintain and Dispose of Patient Medical Records and Keep Client Confidentiality in Mental Health
  • Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines
  • Latest International Financial Reporting Standards (IFRS) Updates: 2-Day In-person Seminar
  • Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
  • Life Sciences Risk Management A to Z - Best Practices for Effectiveness and Efficiency
  • Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer
  • Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
  • Managing Vendor Risk: The Cybersecurity Perspective
  • Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection
  • Managing Your FDA Inspection: Before, During and After
  • Mastering International Customs - INCOTERMS, NAFTA, TPP, TAA, 19 CFR 152 and more: In-person Seminar
  • Mastering Risk Based Internal Auditing (RBIA): 2-day Comprehensive Workshop
  • Medical Device Architecture - Design for Safety: 2-Day In-Person Seminar
  • Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency
  • Medical Device Single Audit Program (MDSAP) - How to implement MDSAP in an existing Quality Management System (QMS)?
  • Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
  • Meeting ILAC Requirements for Measurement Traceability to the SI through NIST and other National Metrology Institutes: 2-Day In-Person Seminar
  • Method Development and Validation for Assays Supporting Testing of Biologics
  • Metrics & Predictive Analytics in Human Resources-Reducing Risk and Improving Productivity
  • Modern HIPAA Compliance - Managing Privacy, Security, and Breach Notification in a World of New Technologies, New Threats, and New Rules
  • Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits
  • Negotiating the Labor Agreement
  • New Hazard Communication & Global Harmonized System, and OSHA Record Keeping
  • NIR Spectroscopy in the Life Science Industries (Pharma and BioPharma)
  • Operations Risk Management and Mitigation - from Assessment to Implementation
  • Overview of clinical drug development from final preclinical selection, marketing approval, all phases of clinical trials, new strategies, challenges and solutions: 2-day In-person Seminar
  • Packaging and Labeling in Pharmaceutical Production: 2-Day In-Person Seminar
  • Payroll Best Practices: 10 Areas You Must Handle Correctly to Ensure Compliance
  • Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations)
  • Pharmaceutical Supply Chain Integrity - Good Distribution Practices (GDP)
  • Preventing Root Cause and Conduct Analysis for Corrective Action after an Incident or Non-conformance
  • Principles and Application of Hazard Analysis Critical Control Point (HACCP)
  • Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
  • Project Management for Banks and Financial Institutions
  • Project Management for Human Resources
  • Project Management in Accounting: 3-Day Workshop
  • Project Management in Clinical Research
  • Project Management in Human Resources - 3-Day Certification Program
  • PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
  • Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
  • Quality by Design: A New Paradigm for the Development and Commercialization of Biopharmaceuticals
  • Quality Control Laboratory Compliance - cGMPs and GLPs
  • Radiation Sterilization of Medical Products - Beyond the Basics
  • Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
  • REACH and RoHS Compliance: Gain a Deeper Understanding
  • REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
  • Recognizing and Investigating Payments Fraud
  • Recordkeeping and Documentation in a GLP Laboratory (US FDA, US EPA and OSHA Focus)
  • Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
  • Regulatory Requirements and Principles for Cleaning Validation: 2-Day In-person Seminar
  • Risk Management in Medical Devices Industry
  • Roadmap of California Medical Leaves - Ultimate Guide to PDL, FMLA, FEHA, SDI, CFRA, PFL, ADA and Workers Compensation and Handling Performance Management Challenges
  • Roadmap to Advanced Human Resources and Employment Law Essentials
  • Robust Quality System Approach to Pharmaceutical Products: Scientific Basis and Implementation of Current Regulations
  • Root Cause Analysis and CAPA using 8-D Problem Solving Method
  • Sales and Use Tax - Compliance and Best Practices
  • Sample Size Justification & Statistical Analysis for Performance Qualification (PQ) Studies
  • SOP Writing, Training and Compliance in the Pharmaceutical Industry
  • SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
  • Statistical Analysis for Process and Product Development
  • Statistical Analysis for Product Development: 2-day In-person Seminar
  • Statistical Process and Quality Control
  • Statistical Techniques for Medical Device Manufacturers: 2-Day In-Person Seminar
  • Statistics for Quality Engineering
  • Strategic Human Resources Management Program for HR Professionals
  • Strategic Supply Stream - Developing perspective- C-TPAT, ISA, Trusted Trader SRM/SSRM
  • Supplier and Contractor Qualification and Control for Life Science Industry
  • Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar
  • Supplier Quality Agreements - Essential for suppliers of most outsourced processes
  • Systematic Operating Procedures (SOPs) – What’s Really Required
  • The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products
  • The Benefit/Risk Ratio: Pharmacovigilance, Medical And Regulatory Converge: 2-Day Workshop
  • The Challenges of an Effective Change Control Program and How to Address OOS Results
  • The Complete Payroll Law Seminar - Red flags, Most Recent Case Studies affecting Payroll, Overtime Pay, Comp Time, the FMLA, the ACA and Many More
  • The Development and Implementation of a Robust Food Safety, Defense and Quality Assurance System
  • The Internal Audit Function
  • The Life Cycle Approach to Cleaning Validation
  • The New OSHA Recordkeeping Rule & Surviving An OSHA Audit: In-Person Seminar
  • The Regulations of OTC Drugs
  • The Unthinkable: Violence in Healthcare - From Bullying to an Active Shooter
  • The Veterinary Drug Approval Process and FDA Regulatory Oversight
  • Trade Compliance Seminar - Harmonized Tariff Schedule/Schedule B and Import Documentation and Procedures
  • Trade Compliance Seminar - Harmonized Tariff Schedule/Schedule B and NAFTA Rules of Origin and Documentation
  • Understanding and Implementing a Quality by Design (QbD) Program
  • Understanding and Implementing the New ICH/USP Elemental Impurity Guidelines
  • Understanding Developments in Employment Law, be ''Best in Class'' - EEOC Focus, EEO-1 Report Changes and Key Court Decisions
  • Understanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies
  • US and Canada Customs Brokerage - A Thorough Analysis: 2-Day In-person Seminar
  • US GCP Fundamentals for Pharmaceutical and Biologic Companies
  • US Good Clinical Practice (GCP) Regulations and ICH GCP Guidelines
  • US Immigration Compliance Training & Defense Strategies in the TRUMP Era
  • Using Process Failure Mode & Effects Analysis (FMEA) to Identify and Manage Risks to Internal and External Customers
  • Validation and Part 11 Compliance of Computer Systems and Data
  • Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
  • Vendor and Supplier Qualification Program for FDA Regulated Industries
  • Why is FDA at my facility, and what do I do during an inspection?
  • World Class Cyber Incident Response Plans: Strong Responses to Attacks
  • World Class Risk Management - What The Best International Standards Say About Risk - ISO 31000, ISO 14971 and ICH Q9
  • Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)
•  EMPLOYMENT LAW
  • Wage and Hour Law Under the FLSA: 2-Day In-person Seminar
•  EXECUTIVE EDUCATION
  • The Job of the Corporate Controller in Today's Environment
•  FINANCE INVESTING
  • Basel III, IV and Beyond - Effective Risk Data Management and Reporting
  • Credit Risks and Risk Mitigation Techniques: 2-Day In-person Seminar
  • Financial Reporting Disclosure Statements: 2-Day In-person Seminar
•  HUMAN RESOURCES MANAGEMENT
  • A+ PHR/SPHR Certification Review Program
  • A+ PHR/SPHR/PHRca Certification Review Program
  • CA HR 101 - HR Generalists and CA Supervisors Too
  • How To Conduct Workplace and Employee Relations Investigations: 2-day Workshop
  • Human Resources and Employment Law Essentials: 2-Day In-Person Seminar
  • I-9 and Immigration Enforcement Bootcamp: Employer Best Practices & Compliance
  • Roadmap to Human Resources and Employment Law Essentials: 3-Day In-person Seminar
•  LAW
  • Clinical Data Management (FDA E6 GCP Guidelines): 2-Day In-Person Seminar
•  MANUFACTURING OPERATIONS
  • Process Validation for Medical Devices: 2-day In-person Seminar
•  ORGANIZATIONAL DEVELOPMENT
  • Driving Operational Excellence Through The Organization using Quality Tools and Processes : One and a Half-day In-Person Seminar
•  PROJECT MANAGEMENT
  • Project management tools to improve productivity and compliance in Analytical laboratories: 2-day Workshop
•  SOCIAL MEDIA
  • Social Media Crisis Management: 2-Day Workshop