Our goal is to help improve the safety, efficacy, and quality of FDA Regulated products and services, by developing advanced experiential learning opportunities for industry professionals and creating forums with the intent to resolve leading industry challenges. Through strong partnerships with the FDA and our Board of Executive Advisors, we work to foster critical thinking and change management in a way that produces sustainable results.
How have you implemented ICH Q9 in a way that has made a measurable difference?
What is the impact of not implementing a 3rd party auditing strategy in the industry?
Why is supply chain transparency and pedigree so critical?
Does your current training program involve experiential learning?
Do you feel that a product containing known critical defects can be inspected and released?
When do GMP’s start?
Do you and your organization have the leadership and culture necessary to facilitate change that will last?
Articles, Case Studies, Links and Discussions - The Med-XU News & Views page covers all the latest news in the pharamceutical and medical device industries, in one place. Join the Conversation
Risk Management: Applying ICHQ9 To the Pharmaceutical Business
Since the late 1970s, the pharmaceutical industry has been looking for guidance. Before they can release new drugs to consumers, these companies need to know how to maintain compliance with somewhat vague regulations from the FDA. But in an increasingly competitive landscape, they also need to know how to succeed as a business. Med-XU recently tackled the question of how risk management can make--or break--today's pharmaceutical company.
The Med-XU goal for consulting is for you to not need our services. We work to identify the quickest way possible to provide you with sustainable processes and systems so you can be confident in your own compliance and technical abilities.
FDA Readiness Inspections: To ensure an exceptional approval process
Validation support: With expertise in manufacturing, packaging, and laboratory validation
Supply chain management: Full compliance requires full understanding and implementation. We can help.
FDA liaison: Ensure that your your 483 and Warning Letter responses will have the quality the FDA is seeking.
Process Excellence: Process excellence paired with risk management is a critical combination for success. Let us show you how. Learn More.
Come and hear what top level FDA, Field Investigators, and Industry Experts are saying about challenges faced globally across the industry. Targeted for companies of all sizes and employees at all levels, this conference offers separate tracks for Quality, Regulatory, and Clinical Trials.
Join client companies, contract companies and regulatory authorities as they resolve key issues on global outsourcing for the pharmaceutical industry. With a focus on communication, this conference will provide dynamic, interactive forums for participants to engage each other on the industry's top challenges.
Facilitated Learning. Sustainable Growth.
Med-XU’s approach of facilitated learning enables the participant to learn through guided self-discovery, and often involves experiential learning. Our training courses include didactic teaching, live simulations, case studies, discussion/debate, and contemplation that lead to the development of meaningful implementation plans. We foster the critical thinking that allows the participant to create change with sustainable impact.
