2 Sections Web-based Seminars

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel Overview: This webinar will cover several recommendations to improve the hospital's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: * DEA Office of Diversion  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the Pharma - it is a good regulation for medical and Pharma companies but it is also a good guideline for other industries. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection.  more...

GMP Expectations for Products Used in Early Phase IND Studies - Webinar by GlobalCompliancePanel FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence  more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA  more...