Training Doyens

OVERVIEW Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs (standard operating procedures) that accomplish that objective. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well-written SOPs ensure consistent process output and quality results. Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well-written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work. WHY SHOULD YOU ATTEND ...

     FDA Audit for Medical Device Firms FDA audit could be nerve-racking for medical device manufacturers if they are not well prepared. Over the last few years, medical device firms have encountered a significantly heightened number of inspections that resulted in increase in the number of citations. Although difficult, FDA audit is an important aspect of  medical device industry . However, especially for startups, the first audit could be quite difficult to handle as the checklist of FDA could scare away the potential investors or customers, hindering the organization’s goal and efforts. Moreover, FDA sometimes announces their audit beforehand but the regulators may also turn up any time for inspection, without any notice. This implies, being a medical device manufacturer, you always need to be prepared for going through an FDA audit. Here are some of the basic steps that you must follow to stay prepared and confidently survive an FDA auditfor medical dev...

OVERVIEW This webinar will review the current regulations, guidancedocuments for GMP Documentation in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labelling, and documentation requirements will also be reviewed and explored. WHY SHOULD YOU ATTEND Attend this webinar so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for your GMP documentation. Good Manufacturing Practices Training AREAS COVERED IND and NDA Content and Format for CMC Information Vendor Selection and Management for Outsourcing early Manufacturing Raw Material Selections and Considerations Required SOPs and Documentation LEARNING OBJECTIVES Learn the rules and regulations governing GMP Documentation. Also learn about the development and implementation of strategies ...