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Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations
Palo Alto
6/19/13 10AM - 11:30AM
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ComplianceOnline
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.
Events
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations 6/19/13 10AM - 11:30AM 2013-06-19 10:00:00 2013-06-19 11:30:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This training on avoiding FDA 483 observations will address the adequate investigation of deviations, an area that is receiving FDA...
Documenting Performance and Administrating Progressive Discipline 6/19/13 10AM - 11AM 2013-06-19 10:00:00 2013-06-19 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This HR compliance training will discuss the methods for implementing effective discipline policies and setting performance improvement...
The Sunshine Act Reporting for Clinical Trials 6/20/13 10AM - 11AM 2013-06-20 10:00:00 2013-06-20 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of...
Writing Effective Appeals for Orthopedic Denials 6/20/13 10AM - 11AM 2013-06-20 10:00:00 2013-06-20 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This healthcare training will discuss specific issues related to orthopedic claims, writing effective appeal letters, issues related to...
Invoice Automation - How do you make companies and their suppliers happy? 6/20/13 10AM - 11AM 2013-06-20 10:00:00 2013-06-20 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This training on accounts payable (AP) automation will highlight its emerging market specifically the invoice side of the process and it...
How to Protect Your Intellectual Property Overseas 6/20/13 10AM - 12PM 2013-06-20 10:00:00 2013-06-20 12:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This training will review a number of actions exporters should take to protect their patents (inventions), trademarks (words and symbols...
The Role of Lab Data in the Drug Development Process: Adverse Events and Subject Safety 6/21/13 10AM - 11:30AM 2013-06-21 10:00:00 2013-06-21 11:30:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This webinar on the role of lab data in drug development and clinical research safety monitoring will provide tips on how to analyze lab...
Developing and Using HR Audit Tools 6/21/13 10AM - 11AM 2013-06-21 10:00:00 2013-06-21 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This Webinar will discuss the development and use of HR audit tools. The session will cover critical HR audit issues reviewed including...
Clinical Trial Billing - Building a Compliant Process that Works! 6/21/13 10AM - 11:30AM 2013-06-21 10:00:00 2013-06-21 11:30:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This webinar will show how you can devise a clinical trial billing system/ process to manage the billing of clinical trial charges in...
How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws and Regulations 6/24/13 10AM - 11:30AM 2013-06-24 10:00:00 2013-06-24 11:30:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This webinar on FDA social media regulations will discuss the best practices utilized by medical device, drug and other FDA and FTC...
21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s 6/25/13 10AM - 11:30AM 2013-06-25 10:00:00 2013-06-25 11:30:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product...
Vendor Qualification and Validation of Reagents in a GLP/GMP Laboratory 6/25/13 10AM - 11AM 2013-06-25 10:00:00 2013-06-25 11:00:00
This laboratory compliance training will explain how to qualify and validate vendors for reagents in a GLP/GMP laboratory. Why Should You...
OSHA injury and illness recordkeeping compliance 6/26/13 10AM - 1PM 2013-06-26 10:00:00 2013-06-26 13:00:00
This OSHA Recordkeeping training will address the key concepts in understanding the OSHA recordkeeping analysis through recent OSHA...
Foreign Corrupt Practices Act & UK Anti-Bribery 6/26/13 10AM - 11AM 2013-06-26 10:00:00 2013-06-26 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This Foreign corrupt Practices Act (FCPA) compliance training will discuss common red flags for potential breaches of the Act and recent...
Evaluating your Ethics and Compliance Program for Effectiveness: A Checklist and the Business Case 6/26/13 10AM - 11AM 2013-06-26 10:00:00 2013-06-26 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This corporate ethics and compliance training will provide you simple, but powerful, tools to evaluate your organization’s ethics and...
Introduction to Bioequivalence and Therapeutic Equivalence 6/26/13 10AM - 11AM 2013-06-26 10:00:00 2013-06-26 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This webinar on bioequivalence will use a case study approach to explore the regulatory issues relevant to the approval of medications...
Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements 6/27/13 10AM - 11AM 2013-06-27 10:00:00 2013-06-27 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This dietary supplements quality compliance training will review the FDA regulatory requirements for manufacturing and commercialization of...
Food Allergen Control for Food Industry Professionals 6/27/13 10AM - 11:30AM 2013-06-27 10:00:00 2013-06-27 11:30:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This food safety training will provide a comprehensive understanding of food allergens and the risks involved. You will learn how to...
The 6 Most Common Problems in FDA Software Validation & Verification 6/27/13 10AM - 11AM 2013-06-27 10:00:00 2013-06-27 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on...
3-hr Virtual Seminar - Japan: Regulatory Compliance Requirements for Life Science Products 6/27/13 10AM - 1PM 2013-06-27 10:00:00 2013-06-27 13:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This 3 hour virtual seminar on Japan regulatory compliance requirements will explain the country's regulations and processes (including...
Internal Control in Payroll 6/27/13 10AM - 11:30AM 2013-06-27 10:00:00 2013-06-27 11:30:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This webinar highlights the principles and techniques for internal control in payroll. After a general placement into the COSO framework,...
Top 10 Tips When Importing to Ensure Compliance 6/27/13 10AM - 11AM 2013-06-27 10:00:00 2013-06-27 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This U.S. Customs & Border Protection (CBP) compliance training will help you understand best practices when importing products into the...
CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment 6/28/13 10AM - 11:15AM 2013-06-28 10:00:00 2013-06-28 11:15:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated, non-waived laboratories that run...
Environmental Monitoring and Contamination Control Plan 6/28/13 10AM - 11:30AM 2013-06-28 10:00:00 2013-06-28 11:30:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This 90-minute cleanroom contamination control training will review the common mistakes that people make in cleanrooms that lead to...
Legal and Practical guidelines for Dealing with Psychiatric Disabilities at Work 6/28/13 10AM - 11AM 2013-06-28 10:00:00 2013-06-28 11:00:00
Online Webinar 2600 E. Bayshore Road Palo Alto , CA | View map
This 60 minute webinar on how to deal with psychiatric disabilities at work addresses w.r.t. both the legal and psychological issues that...
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