Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter
Date
Tue, Jan 25, 2011 at 10:00 am to 11:00 am PST
Palo Alto, CA
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Tue, Jan 25, 2011 at 10:00 AM PST
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EVENT NAME
Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter
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2600 E. Bayshore Road Palo Alto, CA, United States-94303
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Tue, Jan 25, 2011 at 10:00 am to 11:00 am PST
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Training Option
Tue, Jan 25, 2011 at 10:00 am to 11:00 am
Event Details
Why You Should Attend:
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
Areas Covered in the Seminar:
How to prepare for an FDA inspection.
Development and contents of an SOP for FDA inspection.
Personnel training before inspection.
How to behave during an inspection.
Limitations of scope of inspection.
Response to investigation findings.
FDA guidance documents used by their inspectors.
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Product Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know
Understanding the New USP Chapter <1224> for Transfer of Analytical Methods
HACCP Webinar: Setting up HACCP Plans for Small Companies
Confined Space Entry Permit Program - OSHA Regulation 29 CFR 1910.146
21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s
Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.
Social Media: Using The Legal Guideposts to Create Social Media Success (for Healthcare/Lifescience Companies)
Personnel Practices and Microbial Control in Pharmaceutical, Biotech, and Medical Device Manufacturing
FLSA Pitfall to Avoid - Overtime and Wage Compliance
OSHA Fall Protection Program: 29 CFR 1926.500 - 503
Preparing for FDA's Unique Device Identification Rule
Throwing the Data Over the Wall: Why No One Knows the Quality of the Clinical Data
Understanding Expanded Access for Medical Devices
SOX Compliance for IT Companies - Implementing Corporate Governance and Internal Controls
How to Write a Safety Plan that Complies with OSHA Requirements: Evacuation, Fire, Hazard Communication and Others
Laboratory Inspection Readiness - Implementing GMPS for the Pharmaceutical Laboratory
NLRB Effects on Social Media, Non-Union Employers and Other Changes
Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan
Statistics in Quality Control: Critical Decisions - Risks & Basics
Immunogenicity to biologics: processes, impact on efficacy and safety, and management strategy
Roadmap of California Medical Leaves: Ultimate Guide to PDL, FMLA, FEHA, SDI, CFRA, PFL, ADA and Workers Compensation
Deviations: What are they? Do you need to report?
Selection and Use of (Certified) Reference Material in Analytical Laboratories
Reducing eDiscovery risk for Pharmaceutical Companies
Patient Reported Outcomes (PROs): Overview and Guidance for clinical trials and medical product labeling
The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?
Internal Controls in Purchases, Accounts Payable and Payment
Food Recalls - Planning and conducting a Food Recall and Crisis Communication
Modifications to a Cleared Device - FDA's 510(k) Guidance
FDA Enforcement and Your Compliance Program
How to Obtain a Canadian Medical Device License
Procurement Cards (P-Cards) - Fraud Detection, Prevention, and Deterrence
Healthcare Data Breach Prevention - Securing Patient Datas
Sampling Plans for (FDA) Quality Audits
Negotiating Clinical Trial Contracts in a Minefield: The Stark Rule, Anti-kickback Statute (AKS), False Claims Act (FCA) and Medicare Secondary Payer Rule (MSPR)
Gluten-Free Labeling Under the Current Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 and Beyond
Mitigating the Risk of Wage Claims: Workers misclassification and IRS Audit
3-hr Virtual Seminar: Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry
Essentials of Sterilizing Grade Filter Validation
Effective Discipline and Lawsuit-Proof Termination: How to Remedy Performance and Conduct Problems While Minimizing Your Legal Risks
Fraud in Social Media and How to Protect Yourself and Your Organization
Optimal Clinical Supply Planning for Global Drug Development
Project Management in Human Resources - Human Resource Project Management Training
Financial Training for Human Resource Professionals - Financials for HR
Food Safety: After Disaster Strikes
Implementing Risk-based Verification for Pharmaceutical Manufacturing Companies
Preparation And Review Of Standard Operating Procedures
Effective OSHA Auditing - Creating Audit Documents for a Successful OSHA Audit
SOX Compliance for Foreign-based Public Companies : Implementing US Corporate Governance and Internal Controls
21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s
Bad Debt Forecasting: Two Methods to Accurately Calculate Future Trade Credit Losses
Superiority, Non-inferiority, or Equivalence Trials: How, Why and When
3-hr Virtual Seminar: OSHA Compliance Strategies for Auditing and Training Programs
cGMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products
IFRS and U.S. GAAP Classification Inconsistencies in the Statement of Cash Flows
2013 Mandatory Food Safety Control Guidance for Retail Establishment
The Customs-Trade Partnership Against Terrorism (C-TPAT)
Regulatory Compliance for Food Supplements in the EU - Registration, Labeling, Acceptable Marketing Claims
CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment
Complying with the Rules & Regulations Pertaining to Letters of Credit: OFAC, Anti-Boycott, and the USA PATRIOT Act
How to Achieve CMDCAS Certification (For Medical Device Companies That Want to Sell in Canada)
How to Build an Anti-Fraud Culture - Going BEYOND Just Ethics
Foreign Material Control in Food Processing
Environmental Monitoring and Contamination Control Plan
The Psychology and Law of Workplace Misconduct: From the Manipulative to the Mentally ill
Reformulating IFRS and US GAAP Statements of Cash Flows for Financial Analysis
Reformulating IFRS and US GAAP Statements of Cash Flows for Financial Analysis
3-hr Virtual Seminar: South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam
Basic Statistics for Microbiological Sampling
How to Comply with Title 14 Code of Federal Regulations (CFR) Part 21, Subpart K Parts Manufacturer Approvals (PMA)
Workable HACCP: Developing and Implementing an Integrated Food Safety Management for Food Businesses
Risk-based Software Validation for Quality System software and Medical Device Data Systems (MDDS)
Knowing Your Risk-Impact Quotient (for Healthcare Organizations)
Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms
Designing Effective and Efficient Extractables/Leachables Studies for Biologics
HIPAA Business Associates - 2013 New Requirements and Responsibilities for Compliance
Engineering Change Management for Pharmaceutical Capital Projects
Understanding Disinfectant Qualification Studies - How to avoid errors
Social Media Compliance for Healthcare Organizations
Podiatry Coding and Billing
Seeking Evidence in Clinical Trials in Hemoglobinopathy
3-hr Virtual Seminar: Affirmative Action and the OFCCP - An In-depth Primer
Practical Tips for Human Resource Recordkeeping/ Documentation Professionals
Dispelling the Myths About Clinical Standardization
Operating vs. Non-operating Items in the Statement of Comprehensive Income under IFRS and U.S. GAAP
3-hr Virtual Seminar - The Interface Between Medicare and Medicaid, Anti-kickback Statute (AKS), Stark II and the Federal Civil False Claims Act (FCA): Is your Organization at Risk?
Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
3-hr Virtual Seminar: Understanding Biofilm and Controlling It in Pharmaceutical Water Systems
OSHA Process Safety Management (PSM) Compliance Directive (CPL) and Interpretations
OSHA Inspections - Avoiding the 10 Most Common Mistakes
Roadmap of California Medical Leaves: Ultimate Guide to PDL, FMLA, FEHA, SDI, CFRA, PFL, ADA and Workers Compensation
Gaining and Re-Establishing Control of Your Cleanroom
Food Recall Insurance: Companies in the United States' Food Supply Chain Should Pay Attention!
Full-day Virtual Seminar : Navigating the Japan Regulatory and Clinical Trial Environment; Conducting Clinical Studies in Japan
BSA Training - Tips & Tools
Construction Fraud - Ways to Identify them and Prevent them
FDA Warning Letter Closeout Program
(Medical Staff) Fair Hearings From a Hearing Officer's Perspective - Is Your Process Lawsuit-proof?
Meet the Tougher U.S. FDA CGMPs
Fraud Awareness Programs
Medical Device Reporting for Manufacturers, Importers and Medical Device User Facilities
Auditing Privacy Companies - Implementing Internal Controls
Gaining and Re-Establishing Control of Your Cleanroom
Emergency Response Preparedness: Creating a Plan That Works
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