Thursday, September 12, 2013

Drug Law: Understanding the Essentials of FDA's Authority over Innovative and Generic Pharmaceuticals: 2-day In-Person Seminar

September 11, 2013 at 8:30am to September 12, 2013 at 4pm – Courtyard Philadelphia Downtown Course Description: FDA authority over both innovative and generic pharmaceuticals is not only pervasive, but imposes duties on industry that, if not followed, expose drug companies and their officia… Organized by ComplianceOnline | Type: seminar
The DHF, Technical File and Design Dossier - Similarities, Differences and The Future

September 12, 2013 at 9am to September 13, 2013 at 6pm – United States Overview: One of our most popular subjects, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documen… Organized by John Robinson | Type: conference
Designing Effective and Efficient Extractables or Leachables Studies for Biologics

September 12, 2013 from 10am to 11:30am – Online Event Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study. Why Should You Attend: The FDA industr… Organized by ComplianceOnline | Type: webinar
Understanding the New USP Chapter <1224> for Transfer of Analytical Methods

September 12, 2013 from 10am to 11:15am – Online Event This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective… Organized by ComplianceOnline | Type: webinar
Complaint Handling in Compliance with FDA and ISO Regulations

September 12, 2013 from 10am to 11am – Online Event This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, w… Organized by ComplianceOnline | Type: webinar
Foreign Clinical Trials not conducted under an IND (21 CFR 312.120)

September 12, 2013 from 10am to 11:30am – Online Event This webinar will discuss requirements for acceptance of foreign clinical studies, the guidance for foreign investigator qualification, foreign research facility requirements and study monitoring doc… Organized by ComplianceOnline | Type: clinical, webinar
Validation of Bioanalytical Assays for Biologicals

September 12, 2013 from 10am to 11am – Online Event This webinar will allow you to determine the ideal strategies for validation of bioanalytical assays for biologicals. You will learn the strengths and weaknesses of various techniques and determine t… Organized by ComplianceOnline | Type: webinar
OSHA Process Safety Management (PSM) compliance directive (CPL) and interpretations review

September 12, 2013 from 10am to 11:30pm – Online Event This 90-minute webinar will help you understand the application and requirements of OSHA Process Safety Management and the topics that have been interpreted and reviewed in the compliance guidelines.… Organized by ComplianceOnline | Type: webinar
SNAP Trafficking - Responding to USDA FNS Violations and Civil Money Penalties

September 12, 2013 from 10am to 11am – Online Event This webinar will discuss how to respond to the USDA FNS notice of violations, including reversing violations, avoiding bans from SNAP program, reducing Civil Money Penalties, appeals, and avoiding p… Organized by ComplianceOnline | Type: webinar