Software Verification and Validation Planning and Implementation

Compliance Online

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View other events hosted by Compliance Online

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

W-2's?, 1099's?, Independent Contractors? Protect Yourself with Proper Classification

Change Control Systems for Medical Devices Current Best Practices for FDA-Compliant Systems

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

Safety Reporting in Clinical Trials: Are you Ready for the New FDA Rules Effective from 28 March 2011?

Presenting the real GCP handbook: Build solid knowledge of GCP by learning the rules exactly as they appear in the official text

IFRS vs. US GAAP

FDA's 2011 Revised 510(k) Premarket Notification Process

Why and How - Verification of Compendial Methods - USP <1226>

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

Documentation and Discipline: Solutions to Successful Outcomes

Validation of Bioanalytical Assays for Biologicals

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

Cat's Paw Theory - The latest threat to employers and how to avoid it

Preventing Device Maintenance Related Recalls

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

Complying with Legal Interviewing and Hiring

Risk Management in (FDA) Quality and Manufacturing Areas - Understanding What the Regulators Expect

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

Major CGMP Issues for 2012 - Webinar By ComplianceOnline

New Changes to the HIPAA Regulations - What's about to go into effect and what else is on the way

OSHA Record Keeping Compliance

Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees

How to Audit remotely using Online Auditing Techniques

How Doctors of Chiropractic can Bill Medicare For Durable Medical Equipment and Stay Legally Compliant

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

SOPs for Clinical Trials - Regulatory Requirement and Key to Effective Management

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

The Odds are Against Auditing: Statistical Sampling in Audit

Implementation of the USP GMP Potency Bioassay Suite

Validation and use of Access Databases in FDA regulated environments

Full Day Virtual Seminar - China: Compliance Processes for Life Science Products

Pre-Demolition Engineering Survey

3-hr Virtual Seminar: Introduction to the Electronic Common Technical Document

3-hr Virtual Seminar - Boot Camp: Untangling the FMLA, ADAAA, GINA, and Workers Compensation Laws

Particulates in Biological products. Why test them and what are the new reporting requirements

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

Life Cycle Validation of GMP Potency Bioassays

4-hr Virtual Seminar - Legal and Practical guidelines for Dealing with Psychiatric Disabilities at Work

4-hr Virtual Seminar - Latin America: Regulatory Compliance Requirements for Life Science Products

Managing OSHA Inspections and Accident Investigations

3-hr Virtual Seminar - OSHA Asbestos and Mold Awareness: All-in-One Session

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

Implementation of Pharmacogenomics into the Routine Clinical Laboratory

Accelerating Bioassay Transfer in a GMP Environment

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

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

When FMLA ends and ADA begins. The FMLA/ADA Crossover: Coordination, Management, and Compliance Strategies

3-hr Virtual Seminar- Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada

Audit/Inspection Preparedness for Clinical Research/Site Coordinators

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

Managing the Risk of Discrimination Litigation with a Compensation Review

FDA's Rules for Financial Disclosure in Clinical Trials Clarified: New Guidance, Practical Application

Dress Codes for the Workplace - Legally Compliant Policies and Guidelines

Reduce the Risks of Foreign Material Contamination - A Manufacturer's Guide in Creating a Foreign Material Control

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

Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment

Doing Business Despite Embargoes and Sanctions: OFAC Licensing

Setting up an Effective Risk Management Program

OSHA Inspections - Avoiding the 10 Most Common Mistakes

How to Survive a DEA Audit

Project Management To Meet CGMP Requirements

How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices

Implementation of Pharmacogenomics into the Routine Clinical Laboratory

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

Foreign Corrupt Practices Act (FCPA) Webinar

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

HPLC Method Development and Validation

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

DMR & DHR - What Is Really Required

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

Laboratory Investigations for Out of Specification Results

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

Complying with Legal Interviewing and Hiring

INCOTERMS - International Commercial Terms

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

System Based Inspections - Laboratory Controls

HIPAA and EHRs: How to Comply with the New Regulations and What to Ask of your Vendor

Making All Data Count: FDA Acceptance of non-US Clinical Trials

Effective & Legal Documentation : If It Wasn't Documented, It Didn't Happen

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

HR for Financial and Senior Management and CPAs: How to Reduce Risk and HR costs

Modeling and Optimizing Process Behavior using Design of Experiments

Off Label Product Use Discussions in Social Media

Issue Detection and Escalation in Clinical Trial Settings

Life Cycle Validation of GMP Potency Bioassays

Handling Supplemental Pay Under the FLSA

Third Party Audit and Certification for Food Manufacturers

21CFR Part 11 - Predicate Rules Compliance

Acceptance Activities in FDA QSR - Regulations and Warning Letters

Pharmaceutical Water System Use & Monitoring

Avoiding Discrimination When Recruiting With Social Media Tools

Uniform Customs and Practice for Documentary Credits

Container Closure Systems for Liquid and Lyophilized Products

Principles for the Management of Operational Risk

HPLC Outside the Box: How to Think Like a Chromatographer

Conducting EU Studies from a US Virtual Biotech Company

Is Food from Chain Safe? Complying with the New Perishable Food Import Requirements

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

Designing Effective and Efficient Extractables/Leachables Studies for Biologics

DEA, Your Registration and How to Lose It

Laboratory Investigation Out-of-Specification Results

How to Organize and Conduct Product Complaint Investigations

The Hero of Manufacturing Contamination Control -- The Microbiology Lab

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

Statistics in Pharmaceutical Quality Control

Logical Water System Validation

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

Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance

FDA Warning Letter - Consent Decree Software Validation

Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals

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

Pre-Approval Statements and Representations by Pharmaceutical Manufacturers

Election Year Legal and Compliance 2012

What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness?

Risk-Based Validation Equipment Validation

How do I Keep FDA Happy with my Contract Manufacturer

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

The 21 Elements of a 510(k)

ICH Q10; moving from GMPs to a Pharmaceutical Quality System

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

Powerful Closed-loop CAPA - Meeting FDA Expectations

How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices

Pharmaceutical Water System Use & Monitoring

Spreadsheet Validation: Understanding and satisfying FDA requirements

Biomarkers for Drug Development: The Emerging Regulatory Landscape

Updating Compliance for Design History Files of Older Products

Container Closure Systems for Liquid and Lyophilized 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

QbD Approach to Analytical Method Lifecycle Design, Development, Validation, Transfer Goals and Objectives

How to Investigate Environmental Monitoring Excursion Limits

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?

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

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

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

Re-examining Sarbanes Oxley for SMEs (Accounts Receivable)

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

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

Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.

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

Laboratory Inspection Readiness - Implementing GMPS for the Pharmaceutical Laboratory

How to Write a Safety Plan that Complies with OSHA Requirements: Evacuation, Fire, Hazard Communication and Others

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

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?

Reducing eDiscovery risk for Pharmaceutical Companies

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

Preparation And Review Of Standard Operating Procedures

Effective OSHA Auditing - Creating Audit Documents for a Successful OSHA Audit

Implementing Risk-based Verification for Pharmaceutical Manufacturing Companies

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

2013 Mandatory Food Safety Control Guidance for Retail Establishment

IFRS and U.S. GAAP Classification Inconsistencies in the Statement of Cash Flows

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

Foreign Material Control in Food Processing

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

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

3-hr Virtual Seminar: South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam

How to Comply with Title 14 Code of Federal Regulations (CFR) Part 21, Subpart K Parts Manufacturer Approvals (PMA)

Basic Statistics for Microbiological Sampling

Risk-based Software Validation for Quality System software and Medical Device Data Systems (MDDS)

Workable HACCP: Developing and Implementing an Integrated Food Safety Management for Food Businesses

Knowing Your Risk-Impact Quotient (for Healthcare Organizations)

HIPAA Business Associates - 2013 New Requirements and Responsibilities for Compliance

Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms

Designing Effective and Efficient Extractables/Leachables Studies for Biologics

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

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?

Operating vs. Non-operating Items in the Statement of Comprehensive Income under IFRS and U.S. GAAP

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

Gaining and Re-Establishing Control of Your Cleanroom

Emergency Response Preparedness: Creating a Plan That Works

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