Agencies Web-based Seminars

The Interactive Agency Emerging Media and Design - Online Course ...agencies, check out this course at UCSD Extension, Digital Arts Center Today's marketing and advertising worlds are quickly moving to digital with both online and offline campaigns being directly impacted by emerging media channels. Led by Digitaria Interactive Executive Vice President Warren Raisch, this course is intended for creative individuals from digital arts, gaming, and immersive  more...

Effective Corrective and Preventive Actions CAPA 10 Steps - Webinar By GlobalCompliancePanel Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Thursday, June 7, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Webinar By GlobalCompliancePanel This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which  more...

South Korea Navigating the Clinical Trial and Regulatory Environment - Webinar By GlobalCompliancePanel This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceutical Products in South Korea. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in South Korea. Tuesday, March 27, 2012 10: 00 AM PST | 01: 00 PM EST  more...

How to Survive a QRM Audit - Webinar By GlobalCompliancePanel Overview: As QRM tools and techniques become more formalized, regulatory agencies are increasingly requiring companies to establish Quality Risk Management Plans for their operations. Such plans are being used as starting points for regulatory audits.  more...

Documentation Path to Home Health Compliance - Webinar By mentorhealth In the current environment of high deficits and economic instability, home health agencies must constantly be vigilant to ensure they are being good stewards of public dollars. Wednesday, October 19, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Business Analyst Competency Development Program ...ependent consultant hired by Federal and State Government agencies to improve Business Analysis on highly visible, operation critical and time sensitive projects. a Member of multiple organizations including the IIBA and PMI Training Highlights: a Role-Specific Training a Hands-on Mentoring a 40 Hours Of Classes a 4 Live Case Studies a 100 Hours Assignments a Real-time  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...art 11 software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address software that is supporting the company's Quality System and cGMP documentation. It will assist in evaluating software vendor claims to separate  more...

Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors - Webinar By GlobalCompliancePanel This webinar will demonstrate how to implement an effective audit program. Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the firm's responsibility to make sure vendors/ suppliers are meeting specifications for the supplied  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...ptable software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address software that is: * As-Product * In-Product * In Production and Test Equipment and * The Quality System A manufacturer is  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...sources on minor issues, and still satisfy the regulatory agencies? How can line operators' brains be engaged by the use of such simple yet powerful tools? Use RCA to facilitate a closed-loop problem resolution system to reduce a fire fightinga and minimize compliance problems. Why Should You Attend: Expectations for meaningful, results driven root cause analysis that addresses and  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ... with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The billions of dollars spent by industry annually for V&V are not providing  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...tem. Why you should attend: The US FDA, and regulatory agencies around the world, are actively promoting the concept of a Pharmaceutical Quality System. The concept of a Quality System was imposed on the medical device industry through the implementation of a regulation - the Quality System Regulation (QSR), 21CFR820, in 1996. It is not clear when and how the FDA will begin to support its  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...ssues or product problems are increasing among regulatory agencies worldwide. To meet the new regulatory climate and be competitive, companies need to reevaluate their vendors and the methods used in selecting, evaluating, auditing, retaining or cutting adrift such regulatory "partners". Why you should attend: The last few years have seen the U. S. FDA come under increasing negative public  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...ions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...product problems that are increasingly seen by regulatory agencies and consumers worldwide. To meet this new regulatory climate and be competitive, companies need to continually reevaluate their change control system and its impact on all areas of a companya ™s cGMP activities. Why you should attend: The last few years have seen an increase in product recalls. For this and other  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...hey view as a lack of oversight of business by regulatory agencies, including the FDA. "Business as usual" is unacceptable. Recently several once 'model' companies have received multi-million dollar fines, with one facing criminal charges. Don't let you or your company be caught of guard by these major shifts in emphasis. Modify your internal audits to get 'in sync' with the FDA's shift in  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...void product recalls Why you should attend: Regulatory agencies expect manufacturers to periodically demonstrate that cleanrooms and controlled environments perform according to their design specifications. In addition, periodic testing confirms the efficacy of maintenance and process controls. It is the responsibility of the Cleanroom owner to maximize the value of cleanroom testing to  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...ts of CAPA process step as required by ISO and regulatory agencies. In addition, it is represented in a practical and proven manner which can be immediately applied in your organization. Areas Covered in the Seminar: * Module 1 o Introduction and Overview o Correction vs. Corrective Action + Understanding of all elements of CAPA process step  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...ning more effective. Why you should attend: Regulatory agencies around the world require that training on good manufacturing practices (GMP) be conducted on a regular basis for those who are involved in producing pharmaceutical and biological products. Documentation is also needed as evidence that the training occurred. More and more frequently, regulatory agencies and their inspectors are  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...s, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. The current regulatory climate will be discussed in depth and several examples will be  more...

Quality Systems Inspection Technique QSIT and How to use it to Your Advantage GlobalCompliancePanel brings a new webinar on the topic of Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage Webinar will be on March 11, 2010. Webinar will be presented by Jeff Kasoff. Mr. Kasoff is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is  more...

The 510k Submission Requirements Contents and Option GlobalCompliancePanel brings a new webinar on the topic of The 510(k) Submission: Requirements, Contents, and Option. Webinar will be on March 4, 2010. Webinar will be presented by Jeff Kasoff. Mr. Kasoff is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for  more...