Particulates in Biological products. Why test them and what are the new reporting requirements
Date
Tue, Jan 31, 2012 at 10:00 am to 11:30 am PST
Palo Alto, CA
Date, Time and Location
Starting
Tue, Jan 31, 2012 at 10:00 AM PST
Ending
Tue, Jan 31, 2012 at 11:30 AM PST
Location & Address
Online Event
2600 E. Bayshore Road
Palo Alto, CA
United States-94303
Maps
Weather
Tweet
Share with friends
Share/tag this page
Your Name
*
Your Email
*
84
+
3
=
*
Subject
*
Recipients
*
Message
*
(
see sample format
)
Hello,
I was on eventsbot website and noticed that you might be interested in this event. Click on this link to take a look
http://www.eventsbot.com/events/eb992624899
[YOUR MESSAGE]
EVENT NAME
Particulates in Biological products. Why test them and what are the new reporting requirements
LOCATION
2600 E. Bayshore Road Palo Alto, CA, United States-94303
DATE OF EVENT
Date
Tue, Jan 31, 2012 at 10:00 am to 11:30 am PST
Add to My Calendar
Register Now
Ticket Types
Price
($)
Fee
($)
Qty
Paid
(more)
299.00
5.98
USD
1
27078
299.00
5.98
Paid
N/A
1
Sale Ended
Ticket :
Paid
Price :
$299.00
Fee :
$5.98
Sale Ended
More Details :
Training Option
Tue, Jan 31, 2012 at 10:00 am to 11:30 am
Event Details
Why Should You Attend:
Particulates in Biologics injectibles can arise from the aggregation of the protein product. It has been suggested that the aggregated material presents a safety concern because it increases the possibility of formation of anti drug antibodies. The FDA has therefore requested BLA sponsors to present sub-visible particulate data at the clinical and commercial stage and has identified the 0.2 - 10 micron as a range where there is a lack of suitable techniques for testing particles. Whether the aggregates in protein therapeutics truly increase the immunogenicity of the product is not completely clear and continues to be debated in the industry. Nevertheless this debate has increased the scrutiny of reviewers on the testing and reporting of particulates in Protein Therapeutics.
This webinar addresses recent discussions in the industry related to testing sub-visible particulates in Biologics injectibles. Recent FDA expectations for reporting data will be discussed. Methods for characterization and routine testing of particulates, their advantages and limitations will be discussed. Case studies where the various methods have been used for characterization of the sub-visible particles will be discussed.
Areas Covered in the Seminar:
Why test for sub-visible particulates in protein therapeutics.
Current expectations for testing for particulates in protein therapeutics.
USP method for particulate testing in injectibles.
Commonly used 'work-horse' methods for particulates: SEC and SDS-PAGE.
AUC and FFF.
Light scatter methods.
Imaging methods.
Electronmicroscopy.
For More Details:
http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=701600?channel=eventsbot
Event Hosted By
ComplianceOnline
Get trained on regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands.
Contact the Organizer
Send an Email
Your Name
*
71
+
3
=
*
Your Email
*
Message
*
View other events hosted by
ComplianceOnline
Medical Device Changes and The 510(k)
Project Management for FDA-Regulated Companies
Integrating Clinical Evaluation and Risk Management (ISO 14971)
How to Investigate Water System Contamination with Example Case Studies
Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137
Recalls of Medical Devices in the US
Controlling Change to meet GMP Requirements
Establishing Global Drug Substance and Drug Product Specifications - What the Guidelines Don't Tell You
Wellness Programs - Ethics and Engagement issues - Going beyond legal requirements
Change Control Systems for Medical Devices Current Best Practices for FDA-Compliant Systems
W-2's?, 1099's?, Independent Contractors? Protect Yourself with Proper Classification
Clear as Mud: Obtaining and Marketing Your 510(k) With Today's FDA
How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
Clear as Mud: Obtaining and Marketing Your 510(k) With Today's FDA
Eliminate the Confusion -Annex 13 GMP guide
Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter
Assessing FDA's Proposed Changes to the 510(k) Process in 2011
Full Day Virtual Seminar - Understanding Biofilm and Controlling It in Pharmaceutical Water Systems
Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge
Trial Master File for Research Sites: Can You Pass FDA Inspection?
Ethics, Standards and Identifying Risks in Clinical Research
Making Correct Employee- Contractor Classifications
Maintaining an Effective Safety Program - No Matter the Cost
3 hr Webinar on - Garnishments: Complete and In-Depth
Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements
Form W-4: Best Practices for Efficiency, Customer Service and Compliance
Payment Changes in Health Care are coming - Are You Prepared
How to transfer QC procedures for commercial products in pharma industry - ICH and USP guidelines
Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations
Inexpensive Food Safety and Traceability Solutions Using Process and Quality Control Concepts
Understanding and Implementing FDA'S 21 CFR Part 11
Webinar on Applicant Background Investigations
Compliance with The European Medicines Agency reflection paper on e-source data
Risk-Based Verification and Validation Planning to Meet U.S. FDA, ICH Q9 and ISO 14971
Webinar on Medical Device Tracking
China - Compliance Processes for Life Science Products: Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations
Clinical Trial auditing - Identifying risks and building a more compliant and successful trial
PPACA - Employer Notifications and Reporting Requirements
CE Marking: Obtaining and Maintaining EU Compliance Under the Medical Device Directive - ComplianceOnline
21 CFR Part 212: Quality Systems to Ensure cGMP Compliance
Workplace Hostility: Myths and Realities
Responsibilities of a Principal Investigator in Clinical Trials: What you Must Do to Ensure Trial Compliance
Don't RISK to ignore RISKS. Understanding ISO 14971
ComplianceOnline Virtual Seminar - Auditing and Administrating Human Resource Policies and Practices
Alternative Food Preservation: Sterilization
Techniques of Hazard Recognition
Stability Program to support Shipping and Distribution of Drug Products
IFRS and Effective Fraud Prevention Strategies
Writing effective Risk Assessments to meet BRC Certification Requirements
Software Verification and Validation Planning and Execution
Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance
Social Networking a cause of Concern for HR Professional: Complying with Employment and Labor Laws
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
How to secure GCP compliance in Clinical Trials: The complete overview of the critical parameters
IFRS VS GAAP: Essential Knowledge & Understanding - 4 hrs Webinar
Integrating a Quality Management System and Risk Management for Medical Devices
How to Deal with the IRS and other Governmental Agencies
Bioanalytical Methods Validation
Implementation of Rapid Microbiological Methods
Last changes in Canadian ethics regulations for clinical trial
PPACA - Large Employer Penalties Overview
Basic and Meaningful Human Resource Metrics
How to reduce EO residuals in medical devices
Integrating a Quality Management System and Risk Management for Medical Devices
How to prepare for Increased OSHA penalties in 2011
21 CFR Part 11 Compliance; specifics needed to eliminate 483s
Introduction to ISO 13485 Quality Management System for Medical Devices
Responsibilities of a Clinical Research Coordinator managing clinical trial/s under the supervision of a Principal Investigator
How to Pay Overtime Correctly under the Fair Labor Standards Act (FLSA)
Webinar On IFRS Fixed Assets
Alternative Food Preservation: Pasteurization
The Hero of Manufacturing Contamination Control -- The Microbiology Lab
Dealing With Harassment in the Workplace
Internal Control for Smaller Entities - A Practical Cost - Effective Guide to Strengthening Internal Controls
COSO ERM Simplified - Implementation for Government and small businesses
Design Control Explained
PPACA - Health Insurance Exchange Basics
Webinar On Differences between ICH-GCP and FDA regulations
How to Write SOPs: Tips on Writing the Perfect Document to Impress the FDA
FDA's Proposed Rule Regarding Device Establishment Registration and Listing
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?
Full Day Virtual Webinar : Medical Device Process Validation - FDA Inspectors are Checking - Are You Prepared?
Disinfectant Validation and Cleanroom Cleaning for all FDA and EMEA regulated companies
Reduce COTS Software Validation using the risk-based approach
Identifying and managing unplanned protocol excursions and adhering to GCP
Benford's Law Basics and Application
Understanding and Implementing USP <1058>: Analytical Instrument Qualification
An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
IFRS Financial Instruments - how to comply with changing requirements
Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products
PPACA - Financial Essentials for Employers Overview
10 Major Differences Between Federal RCRA and California Hazardous Waste Regulations
Designing effective and efficient Extractables/leachables studies
Presenting the real GCP handbook: Build solid knowledge of GCP by learning the rules exactly as they appear in the official text
Safety Reporting in Clinical Trials: Are you Ready for the New FDA Rules Effective from 28 March 2011?
IFRS vs. US GAAP
Why and How - Verification of Compendial Methods - USP <1226>
FDA's 2011 Revised 510(k) Premarket Notification Process
How to investigate environmental monitoring excursion limits
Hazardous Waste Regulation: 10 Major Differences Between Federal RCRA and California Hazardous Waste Regulations
Failure Investigation and Root Cause Analysis - Simple Tools, Powerful Results
Critical Pharmaceutical Deviation Handling Practices - Establish a stringent deviation handling system
Going Global: Best Practices for Integrating Business Development and Regulatory Compliance
Trade compliance Seminar - Harmonized Tariff Schedule/Schedule B and NAFTA rules of origin and documentation
FDA's DDMAC Compliance: Current Issues and Emerging Perspectives
Do you have a GCP compliant Trial Auditing System/Process in place? - Risks & Rewards
Construction of the European Drug Master File (EDMF) for Regulatory Agencies
Full Day Virtual Seminar: Reliability Engineering Fundamentals for Medical Devices
Validation of Bioanalytical Assays for Biologicals
Documentation and Discipline: Solutions to Successful Outcomes
The GCP/ICH Obligations of Sponsors, Monitors, and Investigators - Barriers and Solutions
FDA Warning Letter - Consent Decree Software Validation
5-hr Virtual Seminar: GMP Requirements for Combination Products for the Medical Products Industry
CAPA Details, Implementation and Q&A in Medical Device Setting
Sterile Product Assurance - Building a Data Package that Convinces Agencies your Product is Good
Fundamentals of Clinical Research - Key players and roles for a successful and compliant research team
Incorporate FDA's New Process Validation Principles into Company Verification and Validation Planning
New Dietary Ingredients in the Regulatory Scheme
Form W-2 Compliance: Step by Step and Box by Box
The Hidden, Long Term Impact of Layoffs - Alternatives Explored
Clinically-Related 483's and Warning Letters: Getting through the Maze
Draft Guidance for Device Industry and FDA - Postmarket Surveillance
Preventing Device Maintenance Related Recalls
Cat's Paw Theory - The latest threat to employers and how to avoid it
Collection of Applicant Flow Data, Data on Hiring Process Flow, and Use of it in an Affirmative Action Plan
Accounting of Disclosures under HIPAA: What the Rules Require Today and What's Changed by the Proposed Rule
Risk Management in (FDA) Quality and Manufacturing Areas - Understanding What the Regulators Expect
Complying with Legal Interviewing and Hiring
FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program
3-hr Virtual Seminar - Child Support: Complete and In-Depth
New Changes to the HIPAA Regulations - What's about to go into effect and what else is on the way
Major CGMP Issues for 2012 - Webinar By ComplianceOnline
Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees
OSHA Record Keeping Compliance
How Doctors of Chiropractic can Bill Medicare For Durable Medical Equipment and Stay Legally Compliant
How to Audit remotely using Online Auditing Techniques
3-hr Virtual Seminar - IFRS: Financial Instruments
Preparing for FDA GCP Inspections - Essentials for Sponsors and Clinical Sites
OSHA Subpart Z (or IH) Regulations: Everything you Always Wanted to Know About It
FDA's New Food Safety Law - What does It mean for everyone in the Global Food Chain?
SOPs for Clinical Trials - Regulatory Requirement and Key to Effective Management
SOPs for Clinical Trials - Regulatory Requirement and Key to Effective Management
The Odds are Against Auditing: Statistical Sampling in Audit
Validation and use of Access Databases in FDA regulated environments
Implementation of the USP GMP Potency Bioassay Suite
Full Day Virtual Seminar - China: Compliance Processes for Life Science Products
3-hr Virtual Seminar: Introduction to the Electronic Common Technical Document
Pre-Demolition Engineering Survey
3-hr Virtual Seminar - Boot Camp: Untangling the FMLA, ADAAA, GINA, and Workers Compensation Laws
3-hr Virtual Seminar - HIPAA Security Rule Compliance and Risk Analysis: Finding the best ways to reduce security risks and prevent breaches
Full Day Virtual Seminar: Understanding and Effectively Controlling Biofilm in Pharmaceutical Water Systems
How to prepare for and survive a CLIA inspection - Clinical Laboratories Improvement Act
Prepare for Tougher U.S. FDA cGMP Compliance Audits
4-hr Virtual Seminar - Latin America: Regulatory Compliance Requirements for Life Science Products
4-hr Virtual Seminar - Legal and Practical guidelines for Dealing with Psychiatric Disabilities at Work
Life Cycle Validation of GMP Potency Bioassays
Managing OSHA Inspections and Accident Investigations
3-hr Virtual Seminar - HIPAA Privacy and Security Audits and Enforcement: What the new program is about, how it works, and what happens if a violation is found
3-hr Virtual Seminar - OSHA Asbestos and Mold Awareness: All-in-One Session
Implementation of Pharmacogenomics into the Routine Clinical Laboratory
Conducting Reference Checks, Background Checks, and Alcohol and Drug Testing - Webinar By ComplianceOnline
Submission Documentation for Sterilization Process Validation - A Comprehensive View of Content for an Approvable CMC Section
Accelerating Bioassay Transfer in a GMP Environment
The Regulation of Pet Food in the United States
International Trade Finance Payment Methods
Global Data Transfer Solutions - Complying with EU Laws & Regulations
OSHA Recordkeeping: Recent Recordkeeping Interpretations
Defending Against an OFAC Investigation
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Solutions to the Challenges of Phase I and FIM Studies in Today's World
Full-day Virtual Seminar - South Korea: Navigating the Regulatory and Clinical Trial Environment
SSAE 16 (formally known as SAS70), SOC1 to SOC 3 Reporting Demystified
Basics of Testing Associated with Sterilization Validation and Routine Processing
Advanced Methods of Root Causes Analysis for ISO 14971 Risk Reduction
3-hr Virtual Seminar: Project Management in Human Resources
Audit/Inspection Preparedness for Clinical Research/Site Coordinators
When FMLA ends and ADA begins. The FMLA/ADA Crossover: Coordination, Management, and Compliance Strategies
Software Verification and Validation Planning and Implementation
3-hr Virtual Seminar- Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada
Webinar: When Do You Need a 510K?
Method Validation in Drug Development Process - Common Mistakes and Issues
Social Media in a Regulated Environment (for Financial Services)
Managing Immunogenicity Risk in Biopharmaceuticals
FDA's Rules for Financial Disclosure in Clinical Trials Clarified: New Guidance, Practical Application
Managing the Risk of Discrimination Litigation with a Compensation Review
Reduce the Risks of Foreign Material Contamination - A Manufacturer's Guide in Creating a Foreign Material Control
Dress Codes for the Workplace - Legally Compliant Policies and Guidelines
Validation of Bioanalytical Methods and Procedures for FDA Compliance
Ethical Hotlines, Whistleblowers and Compliance with the EU Data Privacy Laws & Regulations
Full Day Virtual Seminar - US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection
Doing Business Despite Embargoes and Sanctions: OFAC Licensing
Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment
Setting up an Effective Risk Management Program
OSHA Inspections - Avoiding the 10 Most Common Mistakes
How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices
Project Management To Meet CGMP Requirements
How to Survive a DEA Audit
Foreign Corrupt Practices Act (FCPA) Webinar
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
Implementation of Pharmacogenomics into the Routine Clinical Laboratory
Archiving GLP Records: How Archiving Makes or Breaks the Audit
Medical Device Risk Management Using ISO 14971
Elegant Quality Assurance Practices for Device Efficacy and Efficiency Requirements
Environmental Monitoring and Contamination Control Plan
The HR Practitioner's Guide To Adverse Impact Analysis
Transportation of Food Products: Temperature Control Compliance and Vicarious Liability
HPLC Method Development and Validation
DMR & DHR - What Is Really Required
Laboratory Investigations for Out of Specification Results
21 CFR Part 11 compliance for Electronic Medical Records
FDA's Oversight of Mobile Medical Applications ("apps") for Use on Smartphones and Similar Mobile Devices
Foreign Manufacturing Facilities - Avoiding Problems with FDA
How To Respond To A FDA Inspection And Warning Letter
Full-day Virtual Seminar - Quality Agreements with Pharmaceutical/ Biologic Manufacturers and the Use of Drug Master Files
INCOTERMS - International Commercial Terms
Complying with Legal Interviewing and Hiring
Best Practices for Maintaining an IND and IDE Application with FDA
California Environmental Regulations - Differences Between Federal EPA and State Requirements
Validation and Use of Excel® Spreadsheets in Regulated Environments
You have a Sterility Failure or Bioburden Excursion - Now What?
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer
CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps
Full-day Virtual Seminar: How to Establish A Medical Device Quality System
HIPAA and EHRs: How to Comply with the New Regulations and What to Ask of your Vendor
System Based Inspections - Laboratory Controls
Effective & Legal Documentation : If It Wasn't Documented, It Didn't Happen
Making All Data Count: FDA Acceptance of non-US Clinical Trials
Making Risk-Benefit Decisions - Preparing for the New FDA Guidance Documents
Understanding Disinfectant Qualification Studies - How to Avoid Errors
Good Documentation Practices for GXPs
Fraud - A Lightning Overview
Modeling and Optimizing Process Behavior using Design of Experiments
Issue Detection and Escalation in Clinical Trial Settings
Off Label Product Use Discussions in Social Media
Life Cycle Validation of GMP Potency Bioassays
HR for Financial and Senior Management and CPAs: How to Reduce Risk and HR costs
Handling Supplemental Pay Under the FLSA
21CFR Part 11 - Predicate Rules Compliance
Third Party Audit and Certification for Food Manufacturers
Acceptance Activities in FDA QSR - Regulations and Warning Letters
Pharmaceutical Water System Use & Monitoring
Uniform Customs and Practice for Documentary Credits
Avoiding Discrimination When Recruiting With Social Media Tools
Container Closure Systems for Liquid and Lyophilized Products
Principles for the Management of Operational Risk
Is Food from Chain Safe? Complying with the New Perishable Food Import Requirements
Conducting EU Studies from a US Virtual Biotech Company
HPLC Outside the Box: How to Think Like a Chromatographer
3-hr Virtual Seminar: FDA Medical Device Regulation for the Beginner
Full-day Virtual Seminar: Critical Factors and Complexities in Payroll 201
Complying with the EU Cookies Law Ecosystem
Setting up an Effective Supplier Management Program
FDA 21 CFR Part 11 for techies
Lean Project Management For U.S. FDA-Regulated Industries
DEA, Your Registration and How to Lose It
Designing Effective and Efficient Extractables/Leachables Studies for Biologics
Laboratory Investigation Out-of-Specification Results
The Hero of Manufacturing Contamination Control -- The Microbiology Lab
How to Organize and Conduct Product Complaint Investigations
Global Supply Chain Finance - Today and Tomorrow
Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements and Existing State Requirements?
Trends in Audit, Risk, and Compliance: Integrating your "ARC"
OSHA - 10 Major Differences between Federal OSHA and California OSHA Compliance and Enforcement
Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues
How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities
Calibration and Qualification in Analytical Laboratories
FDA Software Validation Self-Check - plan an effective Internal Audit program
The National Labor Relations Act - Not Just for Union Companies
Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation
Lyophilization Technology: Pre-Formulation and Formulation Development of a Sound Bio Pharmaceutical Formulation that is cGMP Compliant
Developing and Updating a "Compliant" Lab Compliance Plan (Medicare and Medicaid Focus)
Equipment Calibration in FDA QSR - Regulations and Warning Letters
Logical Water System Validation
Statistics in Pharmaceutical Quality Control
IT Risk Management - EU Laws and Regulations
How to Survive the FDA Design Control Inspection: Common Problems and Risk mitigation
FDA Concerns on Alarm Standards and Safety
Why and How - Verification of Compendial Methods - USP <1226>
Cosmetics - How Are they Regulated?
Designing Medical Device Alarms to Mitigate New FDA Concerns
Why and How - Verification of Compendial Methods - USP <1226>
Cosmetics - How Are they Regulated?
Analytical Test Methods Validation: FDA, ICH and USP Requirements
Basic and Meaningful Human Resource Metrics
Supplier Controls to Meet Tougher U.S. FDA Requirements
FDA Warning Letter - Consent Decree Software Validation
Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance
Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals
Pre-Approval Statements and Representations by Pharmaceutical Manufacturers
An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials
3-hr Virtual Seminar - Affirmative Action Compliance and Your Recruiting Strategy: Pulling it together
Election Year Legal and Compliance 2012
Election Year Legal and Compliance 2012
Risk-Based Validation Equipment Validation
How do I Keep FDA Happy with my Contract Manufacturer
What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness?
GLP or GMP: A Comparison in Terms and Application for Drugs and Biologics
3-hr Virtual Seminar: GMP Compliant Stability Program for Pharmaceuticals
Device Corrections and Removals
Service Level Agreements (SLAs) - Preparation Guidelines for Effective SLAs
ICH Q10; moving from GMPs to a Pharmaceutical Quality System
The 21 Elements of a 510(k)
Verification and Validation (V&V) of Software in the Medical Devices
Making All Data Count: FDA Acceptance of non-US Clinical Trials
CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment
Full-day Virtual Seminar: Legal Issues Impacting Human Resource Management
FDA Warning Letter Closeout Program
Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection
REMS Update: Risk Evaluation and Mitigation Strategies - what do you need to do now?
Medical Device: Risk Assessment and Mitigation through FMEA
The U.S. FDA's New Global Engagement Initiative
Understanding and Implementing ISO 17025
Acceptance Sampling by Variables Using Z1.9
FDA's new enforcement initiative - Strategic Software Validation Planning for Executives and Managers
Full Day Virtual Seminar: Understanding and Effectively Controlling Biofilm in Pharmaceutical Water Systems
Understanding and Effectively Controlling Biofilm in Pharmaceutical Water Systems
Telecommuting: Effective Policies, Practices, and Programs
FDA's Regulation of Veterinary Regenerative Medicine: What Industry Needs to Know to Market and Sell a Stem Cell Product for Use in Dogs, Cats, Horses and other Animals
Affirmative Action and Recent Trends within the OFCCP
Risk Management for Human Resources
GAMP® 5 as applied to FDA software validation - strategies to avoid warning letters
Verification of Compendial Methods According to the Revised USP Chapter <1226>
Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial
Supplier Management for FDA Compliance
Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP
Cleanroom Management - From a Microbial Perspective
Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment
Specialized Formulations - Biomolecules
Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies
Making Sense of FDA's (proposed) Rules for the Development and Approval of Biosimilars
Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry
An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials
Strategic Selection and Development of Immunogenicity Binding Methods
Best Practices in Document Approval, Control, and Distribution
How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices
Powerful Closed-loop CAPA - Meeting FDA Expectations
Pharmaceutical Water System Use & Monitoring
Spreadsheet Validation: Understanding and satisfying FDA requirements
Biomarkers for Drug Development: The Emerging Regulatory Landscape
Container Closure Systems for Liquid and Lyophilized Products
Updating Compliance for Design History Files of Older Products
Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA
Design Controls: What to know when it comes to FDA regulated industry?
Process Verification and Validation Planning and Execution
Disinfectant Qualification and Cleanroom Disinfection
The 6 Most Common Problems in FDA Software Validation & Verification
Addressing Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents and Elemental Impurities
Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees
The 510(k) Submission: Requirements, Contents, and Options
Strategies for Preparing and Submitting Successful Citizen Petitions and Suitability Petitions to FDA
Laboratory Water Quality: More to it than you think!
(QMS) Competence and Training Requirements per FDA QSR and ISO 13485
Reducing Ethylene Oxide (EO) Sterilization Costs While Maintaining Regulatory Compliance
Validation and use of Excel spreadsheets in FDA regulated environments
How to Investigate Environmental Monitoring Excursion Limits
QbD Approach to Analytical Method Lifecycle Design, Development, Validation, Transfer Goals and Objectives
Eliminate the Confusion - Analytical Method Qualification and Validation
How to Implement Parametric Release in EO Sterilization - A Practical Approach
Risk Assessment-Compliance Using Easy To Fill Out Documentation
To Validate or Not To Validate: A Daily Question for the Pharmaceutical Scientist
Effective Corrective And Preventive Actions (CAPA): 10 Steps to Success
The Hero of Manufacturing Contamination Control - The Microbiology Lab
Post Market Surveillance for Medical Devices
Writing Effective and compliant SOPs
Clinical Trial Billing - Building a Compliant Process that Works!
Good Distribution and Storage Practices for Life Science Products
How to Decommission a Medical OEM Molding Operation and Transfer it to a "World Class" Medical Contract Manufacturer
CDISC - Insight, Impact and Implementation
Design Controls: What to know when it comes to FDA regulated industry?
Fit for Purpose Validation for Biomarker Methods
Surviving an OSHA Inspection - Dos and Don'ts
Supervisors and Their Role in OSHA Compliance and Safety
Designing Effective Emergency Workplace Plans
Freeze Drying in the Pharmaceutical, Biological and Food industry
How Can I Be a Successful CRC? What I Need to Do? What I Shouldn't Do?
10 Tips for Submitting Human Subjects Protocols
Applying Quality Systems Concepts to Clinical Research Activities
Auditing the Microbiology Laboratory
Mobile Medical Applications for Devices: Trends, Bills and Guidance
Stability Studies for Vaccine Products
FDA's Current Thinking for Industry cGMPs for Phase 1 INDs
3-hr Virtual Seminar: Good Laboratory Practices - A Comprehensive Overview
Low Voltage for Qualified Person
You have a Sterility Failure or Bioburden Excursion - Now What?
You have a Sterility Failure or Bioburden Excursion - Now What?
Risk-based Supplier Control: How to Meet FDA and your ISO 13485 Notified Body's Expectations and Reduce your Own Risk
Gaining and Re-Establishing Control of Your Cleanroom
Gaining and Re-Establishing Control of Your Cleanroom
3-hr Virtual Seminar: IND Applications for Phase I Studies
Ensure Compliance to FDA's Design Control Requirements by using Requirements Management Techniques
Effective Management of Intellectual Property Records
Documentation and Investigative Report Writing
Basic and Advanced Quality Tools: What Every Quality Professional Should Know?
Non-Clinical Studies for Implantable and Interventional Medical Devices - How to Get Started, What to Expect All Along the Way, and How to Avoid Disasters
Effective Use of Validation and Verification to Improve your Food Safety Management System
Monitoring Impurities in Pharmaceutical Products - ICH Q3 requirements
Introduction to Biotechnology Analytical Methods
Current Concepts & Challenges in Cloud Compliance
Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
Interpreting FDA's New Guidance Document on Risk-based Monitoring
Drafting 510(k) Submissions Under New FDA Policies - 2012 & Beyond
Hazardous Waste Operations and Emergency Response - 29 CFR 1910.120
Adjusting your Compliance Program to Meet new FDA Requirements
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
Design History Files and Technical Files / Design Dossiers Required Under the U.S. FDA CGMPS and the EU's MDD
3-hr Virtual Seminar: OSHA National Emphasis Program (NEP) - Anhydrous Ammonia Refrigeration Specific Review
3-hr Virtual Seminar: Learning the OSHA Recordkeeping Analysis
Sanitation and Chemical Safety Training for Food Manufacturing
Personnel Practices and Microbial Control in Pharmaceutical Manufacturing
Are you a New Clinical Monitor Assistant (CMA)? Your Roles and Responsibilities and Tips for Getting you Organized
Preparing for FDA GCP Inspections - Essentials for Sponsor Companies
Study to Support Shipping and Distributing Pharmaceutical Products
Non-inferiority Trials: Practical Issues and Current Regulatory Perspectives
Respirator Protection Program - 29 CFR 1910.134
Quality Risk Management Overview for Pharma and Biopharma, ICH Q9/ISO 14971
Safety Committees - How they Help with OSHA Compliance and Improve Safety
4-hr Virtual Seminar: 21 CFR Part 11 - Complete Manual for Compliance and Success
Succeed with the Tougher U.S. FDA cGMP Compliance Audits
Long-term Preservation of Records Needed for Drug Regulatory Compliance
SOX Compliance: Accounts Receivable Risks and Controls
Dispelling the Myths About Clinical Standardization
Project Management for Computer Systems Validation
3-hr Virtual Seminar: Strategies for Preparing a Successful 510(k) Premarket Notification for FDA Submission
High Voltage for Qualified Person
Importing Electronic Records & Electronic Signatures; 21 CFR Part 11
Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers
Quality Assurance During a Clinical Trial
Records Management Applied To FDA Regulatory Compliance
Practical strategies to Improve Productivity in the Pharmaceutical Laboratory
Establishing Effective Employee Training Programs for Medical Device Companies: What Works and What Doesn't
Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA
Re-examining Sarbanes Oxley for SMEs (Accounts Receivable)
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
Subscribe to feed
powered by
This web page was published using
www.eventsbot.com
–
Online Event Registration and Management Service
. If you have any issues/queries related to this event then please contact event organizer directly. You can also Register, Publish, Manage and Promote your events using eventsbot.
©2013 eventsbot. All rights reserved.