FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar Seminar training classes conferences & workshops presented by Online Compliance Panel register for training on FindaSeminar.com

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Training Course Syllabus:

FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar

Description:

This session will provide the participants with best practices regarding policies and procedures for mitigating workplace violence and hostility. Attention will be devoted to current trends (U.S), civil/legal expectations and necessary policies. Further, the impact that a hostile environment has on productivity and the organizational bottom line will be discussed along with easy remedies to mitigate this impact.

Why Should you Attend

The current thinking of the FDA regarding the use of the Limulus Amoebycyte Lysate (LAL) test for endotoxins in lieu of the rabbit pyrogens test has changed. As a result, the last guidance document, Guideline on Validation of the Limulus Amedocyte Lysate (LAL) Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, which was published in 1987, has been withdrawn by the agency.

Objectives of the Presentation:

• Provide a review of the current testing requirements


• Understanding what happened to the old 87/91 LAL Guidance for industry document


• Learn what has replaced it and why


• Learn common issues, misunderstandings and misinterpretations


• Determine who comprised the agency guidance team involved with in this new proposed Guidance


• Learn the documents supporting this new Guidance


• Learn about sampling, storage, handling and pooling


• How does one transition from one bacterial endotoxin test to another—understand the RPT (Rabbit Pyrogen Test)


• Learn about the Monocyte Activation Test (MAT). Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL


• Understand the FDA´s expectation for screening of therapeutic products.

Seminar Summary:

Learn current testing requirements, what happened to the old LAL Guidance for industry document, documents supporting this new Guidance, more. (see full course description)

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  • Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans Webinar
  • Understanding HTSUS and Schedule B Code Classifications
  • Understanding the CMS' Merit-based Incentive Payment System (MIPS): Are you ready for performance-based Medicare reimbursements?
  • Understanding the Newly Implemented New York State Department of Financial Services’ AML Requirements Webinar
  • Understanding USP 1058 Classification for Equipment Systems in the Pharmaceutical Industry Webinar
  • Unemployment: How to Fight Unemployment Claims and Win Webinar
  • Update on Global UDI Initiatives and Post-Submission Responsibilities
  • Using Business Tax Returns to Analyze Lending Requests Webinar
  • Using Metrics to Monitor and Improve Quality Management System Webinar
  • USPAP Issues & Best Practices for Residential Appraisal Reviewers: Avoiding Violations Webinar
  • Validation of Complex Cell- Based Potency Methods Webinar
  • Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program?
  • Wage and Hour Law - California Style Webinar
  • Waste Management in Healthcare: Tips for Managing Your Waste Streams More Effectively Webinar
  • What Accounts Payable Needs to Know about the FCPA
  • What Every Employer Needs to Know about Proposed Immigration Changes in the Trump Era
  • What Federal Contractors Need to Know About Recruiting and Applicant Tracking Systems Webinar
  • What the Bank's Board Must Know about the Bank Secrecy Act Webinar
  • What the DOL New Overtime Rules Mean to Your Organization Webinar
  • What to Do When You are Sued Webinar
  • What to Expect in 2017 and Beyond for Immigration Law for Employers under Trump Administration
  • When the OSHA Inspector Visits - Will you be Ready? Webinar
  • Why Drug & Dietary Supplement Companies Get Warning Letters: How to Handle and Avoid Them
  • Workplace Civility-Respectful Habits Lead to Increased Productivity, Decreased Liability Webinar
  • Writing Effective Audit Observations Webinar
  • Writing Effective Credit Memos and Loan Narratives Webinar
  • Writing High-Profile Evaluation Reports Webinar
  • Your Sanctions Program and How to Clear True Hits and False Positives Webinar
•  COMPUTERS INFORMATION SYSTEMS
  • Excel - Business Intelligence with Power Pivot Webinar
•  ENGINEERING
  • ISO 9001:2015 Key Concepts – How to perform Internal Audits of Quality Management Systems based on ISO 9001 Webinar
•  ENVIRONMENT
  • The Development and Implementation of a Hands on Day to Day EHS Plant Operating Manual Webinar
•  FINANCE INVESTING
  • Accounts Payable Theft and Fraud: Preventive Techniques to Avoid Loss of Revenue Webinar
  • Benchmarking Your Credit Card Program - How Do We Stack Up? Webinar
  • Cash Flow Analysis Webinar
  • Designing and Using KPIs and Performance Dashboards Webinar
  • Investor Relations for Start Ups: Communication, Transparency, Engagement, Advocacy, Success
  • Invoice Automation - How do you make companies and their suppliers happy? Webinar
•  FOOD INDUSTRY
  • Food Labelling : A Practical Guide for Unambiguous Labelling Information & Compliance with Regulatory Requirements Webinar
•  GOVERNMENT
  • Audit Committee Best Practices
  • Auditing For Internal Fraud
  • Fundamentals of Writing RFPs Webinar
  • How to Assess the Effectiveness of Your Institution's Internal Audit Function Webinar
  • How to Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities Webinar
  • Service Level Agreements (SLAs) - Preparation Guidelines for Effective SLAs Webinar
•  HEALTH CARE
  • 2018 CMS Nursing CoP Standards for Hospitals: Proposed Changes and Updates
  • An Update on Discharge Planning Rules and Regulations for 2018 Webinar
  • Case Management's Role in Managing Third Party Payer Denials Webinar
  • Conducting Highly Effective FMEA to Address the Joint Commission Requirements Webinar
  • Counterfeit Medicine Webinar
  • Developing a Peer Review System Webinar
  • HIPAA Internal Audit Process and Policies: Your 1st Line of Defense Webinar
  • IRBs and the changing landscape Webinar
  • Medical Staff Fair Hearings from a Hearing Officer's Perspective - Is Your Process Lawsuit-Proof Webinar
  • Medicare Beneficiary Identifier (MBI): Transitioning to the New Medicare Card Successfully and Avoiding Costly Denials
  • Promotions from Within: A Potential Source of Liability Webinar
  • Understanding the Decision Points of Self-Disclosures and Repayment Obligations Webinar
•  HUMAN RESOURCES MANAGEMENT
  • ADA Alcoholism and Addiction: How Employers Can Stay Compliant
  • California's Mandatory Paid Sick Leave - Recordkeeping, Anti-Retaliation Requirements and More
  • Changes To California Employment Law Regulations: Updates Effective From Jan 2018 Webinar
  • Conducting Background and Credit Checks Webinar
  • Critical Thinking and Creative Problem Solving for a better Decision Making Webinar
  • Current Legal and Regulatory Challenges for HR Webinar
  • Employee Handbooks: Critical Issues in 2018 Webinar
  • How to Handle Tricky Employee Absenteeism Problems Webinar
  • HR 101 for Non-HR Leaders Webinar
  • HR Metrics: Measuring the Strategic and Tactical Value of an Organization's Human Capital Webinar
  • If It Isn't Written, It Didn't Happen! How Can Employers Create Litigation Proof Decisions!
  • Impact of New California Law on Sexual Harassment Training, Plus Laws and Impact in Other States Webinar
  • Issues, Terminations and Exits: Legal Compliance Webinar
  • Legal Issues Concerning Employees with Psychiatric Illness
  • LGBT Rights and the Workplace Webinar
  • Management Skills: How to Get good Results from Bad Behavior
  • Managing Multiple Priorities for the Front Desk Webinar
  • New AB 450 Obligations Effective January 2018: California Immigration and I-9 Compliance Challenges for Employers Webinar
  • Payroll Benchmarking : Cut Costs, Improve Efficiency Webinar
  • Performance Management: An Opportunity to Motivate Employees & for the Success of an Organization
  • Service Animals, Comfort Animals & Pets in the Workplace: How to Make it work and What you need to Know Webinar
  • Status Classification: Exempt vs. Nonexempt - How to Find and Fix Misclassification Mistakes Webinar
  • Team Effectiveness: The Five Dysfunctions of a Team, Another Look at Patrick Lencioni's Concept Webinar
  • Volatile Termination: Be Prepared to Handle Terminations with Employees Who Are Aggressive, Own Weapons, Have Mental Illness and Other Issues You Are Not Aware They Have!
  • What Hiring and Recruiting Trends Affect Recruitment Process? Trends and Legal Requirements
  • Working In a No-Drama Workplace
  • Workplace Discrimination & Harassment: Personnel Policy & Complaint Procedures Webinar
•  INSURANCE
  • The California Fair Claims Settlement Practices Regulations Webinar
•  MANUFACTURING OPERATIONS
  • Manufacturing Quality Agreements- Qualifying Suppliers & Managing Quality in FDA-Regulated Industries Webinar
•  MARKETING
  • Duty Drawback in Canada - What you need to Know Webinar
•  MEDICINE_NURSING
  • Applying Human Factors and Usability Engineering Throughout the Medical Device Development Lifecycle
  • Best Practices to Prepare for and Manage EU Notified Bodies Audits and FDA Inspections Webinar
  • Developing a Validation Master Plan Webinar
  • DMF under GDUFA - Drug Master Files: New Requirements under GDUFA Webinar
  • Effective Records Management & Document Control for Medical Devices
  • FDA Regulations for Importing and Exporting Medical Devices Webinar
  • FDA's Off-label Promotion in Social Media
  • Hazard Analysis Following ISO 14971
  • How to Break Into Brazilian Market - A Regulatory Overview for Cosmetics and Personal Hygiene Products Webinar
  • Intelligent Approach to Risk-Based Monitoring to Improve Clinical Trial Quality Webinar
  • New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines
  • OSHA Fatal Four - Why Compliance with 'Regulations' Will Not Prevent a Workplace Fatality Webinar
  • Risk Based Clinical Trial Monitoring
  • Special Considerations during Medical Device Design: Dos and Don'ts Webinar
  • Specifications for small-molecule drug products Webinar
  • Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements Webinar
  • Technical Writing in the Pharmaceutical Industry Webinar
  • The Interdisciplinary Chart: How can this affect your reimbursement? Webinar
  • Understanding the Brazilian Regulatory Environment for Medical Devices
•  TECHNICAL ENGINEERING
  • Advanced Googling: How to Stop Searching Like a Google Zombie and Transform Google into your Backup Brain, Robot Assistant and Ambient Sidekick