Release Web-based Seminars

ITIL v3 Release Control and Validation Capability RCV ...g; v3 Service Lifecycle and processes associated with the Release, Control and Validation of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders of the certificate to apply the  more...

Managing Difficult People Training This Managing Difficult People training course teaches students to address difficult people according to their specific behavior. Students will have the opportunity to meet with several Marketing Department team members to address their difficult personalities, follow the guidelines for managing difficult people to decrease the department ' s turnover rate and meet the release date for a new  more...

Hibernate Training This course develops skills in using the Object/Relational Mapping tool Hibernate ® . The course uses the latest release version of Hibernate, 3.2, which is directly related to the new EJB 3.0 version defined in Java EE 5.0. By the end of the course, students will be prepared to set-up and use Hibernate as the persistence mechanism in Java applications.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1: 2006 and ISO 11137-2: 2006. In this one  more...

Good Documentation Practices for Laboratory Operations Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...tory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory personnel need to be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance.  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...tory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices. According to the FDA, if it isn't written down, it didn't happen. As well, if it isna ™t  more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel Overview: This program will provide the content for pharmaceutical manufacturing sites to establish sound quality management system procedures for the disposition of intermediates, API, drug substances, medical devices, finished product, and in-house manufactured components. It will describe a well-defined Quality role, identify requirements for resources, and outline the expectations for  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel ...r examines critical parts of design control after product release including: design change control, design validation, and the Design History File. The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your released products  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel ... criteria prior to issuing the Risk Management Report and release of the product. Companies have not had methods in place to perform this activity, and although some information appears in ISO 14971, there is not sufficient guidance on how to perform Overall Residual Risk Evaluation. Areas Covered in the Session: * Choosing the Evaluation Team * Determining the Evaluation  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ... and management expectations now demanded by FDA with the release of this standard. Areas Covered in the Session: * Specific discussions include * Background of the original guidance, its history, application, and items covered * FDA regulatory authority * Growth of competing standards and the competing expectations of the medical device industry * The history and  more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel ...tory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success, and avoid those frustrating, embarrassing discussions of missing or doubtful data, employees recognize and must follow Good Documentation Practices (GDP). These practices apply to all pharmaceutical and medical device manufacturing, and  more...

Interfacing Design Verification Process Validation and Design Validation - Webinar by GlobalCompliancePanel There is confusion between the requirements for Design Verification, Process Validation and Design Validation. While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements.  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ...roposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical studies will be  more...

Advancements in Simulation Series Webinar 4 Analysis Optimization Webinar 4: Analysis Optimization Register for this series of complimentary webinars to learn about advancements in software driven product design testing. Engineers will gain insight into how to use the latest FEA software innovations to help meet business objectives such as reducing material costs, time to market and field failures. NEi Software FEA experts will provide specific  more...

Advancements in Simulation Series Webinar 3 Nonlinear Analysis Webinar 3: Nonlinear Analysis Register for this series of complimentary webinars to learn about advancements in software driven product design testing. Engineers will gain insight into how to use the latest FEA software innovations to help meet business objectives such as reducing material costs, time to market and field failures. NEi Software FEA experts will provide specific  more...

ITIL Foundation Bridge Virtual Classroom ...to deliver to business expectations as part of the new v3 release of ITIL. This Bridging Course is designed as an update for candidates who hold Foundation certificates from earlier versions of ITIL to a level of knowledge and understanding in line with the ITIL v3 Foundation Certificate in IT Service Management. This course positions the student to successfully complete the associated exam,  more...