8.00 Registration and Coffee 8.30 Chairman’s Opening Remarks Dr Kai Juergens, Senior Project Manager External Manufacturing, Bayer Pharma AG, Germany 8.40 GMP Expectations After the Implementation of Annex 15 • Requirements of Annex 15 • The status of the EMA guide on process validation in GMP environment • Status of implementation from an inspector´s view Klaus Eichmueller, Wolnzach c/o Regional Council Darmstadt, GMP Inspectorate, Germany 9.30 FDA’s Trending New Validation Strategies • Contents of FDA’s Guidance to process validation • How can a global harmonisation be achieved?
Experienced in working with Offshore/Onsite developers and testing teams, managing Software QA Projects from concept through maintenance and providing on-time deliverables with highest quality to the aggressive deadline.
Excellent communication, presentation, and interpersonal skills. Good team player with the ability to lead, manage and work independently in a timely sensitive environment.
PROFESSIONAL SUMMARYA result oriented, hands-on individual with more than 17 years of IT experience specializing in Software testing and Test Strategy/Planning.
Result-driven Quality Assurance professional with solid knowledge in Manual and Automated software testing, Sales Force Automation (SFA) and extensive experience in software development methodologies including both Agile(Scrum) and Waterfall models.
Master Control offers a seamless, out-of-the-box integration with Share Point that capitalizes on the benefits of Share Point while adding truly robust compliance solutions.
Here are just a few ways that Master Control is helping Share Point users control documents and manage business processes with greater ease and effectiveness: Many companies nested in Share Point find themselves having to use separate software solutions for more advanced business processes that Share Point was not designed to handle such as document control and personnel training.
Risk-Based Approaches for Validating Enterprise Share Point Deployment in FDA-Regulated Environments Speaker: Daniel O’Connor, Innovocommerce LLC Date: Jan.
18, 2011 Description: This Webinar by Daniel O’Connor, Co-Founder, Innovo Commerce LLC, will introduce innovative best practice risk-based approaches to validating enterprise Microsoft Share Point deployments in FDA regulated environments.
Experience in multiple industries including Life science/Pharmaceutical, and Health information technology/Managed Care with Software Development Life Cycle, Agile-Waterfall and RUP Methodology, 21 CFR Part 11 Validation, Technical Writing, Change Control Management, testing and implementation of business applications.
QA/Validation experience in all phases of SDLC, including Good Document Practice, requirements gathering, risk analysis, project planning, scheduling, testing, defect tracking, management, and reporting.
This usually results in processes that are overly complicated and time consuming.