Coming Web-based Seminars

WORKPLACE BULLYING - WHAT YOU NEED TO KNOW Bullying in the workplace is a serious issue that employers need to learn how to prevent. There are many bills pending in states across the country that may soon prohibit bullying in the workplace. Many states have already passed bullying in schools laws. This informative and engaging on-line live HR Webinar will provide the basics on what you need to know to prevent bullying in your workplace.  more...

Software Verification and Validation Planning to Meet FDA Requirements - Webinar By GlobalCompliancePanel The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. Wednesday, October 19, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...f electronic records and electronic signature software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...w: The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable  more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel ...ey are to be performed. Common pitfalls and means of overcoming them at each of the steps will be identified by a review of recent Warning Letters. The structure of an Investigation report which satisfactorily documents the investigation will be discussed. Ample time will be available for Q&A halfway through the webinar and at the end. Why you should attend: FDA inspectors have in the past  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...ning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. Companies are outsourcing more; with some thinking they can also outsource some of their cGMP compliance as well. Thus, the U. S. FDA has indicated that a key area gaining attention is a company's suppliers, for services and products / components. Why needed? FDA expectations? How are successful  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...ning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area for maintaining cGMP compliance is Change Control. Yet it often is a companya ™s weakest link in compliance - proven by recent high-profile failures. Why so? FDA expectations? How are successful companies meeting this challenge? Tools that need to be put in place or enhanced.  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...egulatory Process o Japanese Way of Thinking / Coming to Agreement o Important Cultural Issues for Consideration o The Do's and Don'ts of Regulatory Involvement in Japan * How to Use Regulations / Regulatory Contacts to Your Advantage o Agency Interactions o Business Impact Within and Outside of Japan o Professionalism in  more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions. Auditing API producers and suppliers is an important part of GMP compliance programs. Identifying what approach or process to use is examined and the tools to utilize during an audit is also discussed. Audits at best are  more...

Being Assertive Without Being An Ass Discover the keys to being assertive in the workplace with superiors and colleagues without coming across as a jackass.  more...