CD/Recorded-How It Works:
Who will benefit?
These webinar will be beneficial to the following:
QA/QC, Administrative and Project Managers | Drug manufacturers including prescription, over-the-counter (OTC), active pharmaceutical ingredient (API), homeopathic, and medical gas | Consultants | Principal Investigators and sub investigators | Clinical Research Scientists (PKs, Biostatisticians etc) | Safety Nurses | Clinical Research Associates (CRAs) | Clinical Research Coordinators (CRCs) | Recruiting staff | Regulatory Affairs Professionals | Data managers
Webinars included in the Package:
US Food and Drug Administration (FDA) now requires electronic submission for labeler code requests, drug establishment registrations, drug listings, annual renewals, and updates. The electronic process replaces FDA paper forms 2656 (Registration of Drug Establishment/Labeler Code Assignment), 2657 (Drug Product Listing), and 2658 (Registered Establishments’ Report of Private Label Distributors). To transmit files, companies must use the FDA’s Electronic Submission Gateway (ESG). According to FDA, moving from a paper-based format to an electronic system has improved the timeliness and accuracy of submissions. This webinar will provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA.
Objectives of the Presentation:
Camille Davis Thornton, M.S., RAC is the founder of MACE Concepts, LLC, an independent consultancy specializing in providing innovative regulatory, compliance, and training solutions. Ms. Thornton has an M.S. in Biotechnology from The Johns Hopkins University and certifications from the Regulatory Affairs Professionals Society (RAC-US) and the National Restaurant Association (ServSafe® Food Protection Manager, Instructor, and registered Examination Proctor). Additionally, she has over 15 years of experience in multiple regulated industries and actively teaches at the college level.
This presentation outlines the contents of the FDA's Industry Guidance draft document titled Contract Manufacturing Arrangements for Drugs: Quality Agreements issued in May of 2013. While this was issued as a draft document, we know that while there may be some changes in wording, this Guidance Document is notification of FDA thinking and will be enforced as a cGMP document.
This guidance defines a Quality Agreement, what it should contain and responsibilities of both the product owner and the contract manufacturer. This is information that is critically important to all pharmaceutical manufacturers.
Dr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. During his tenure in the pharmaceutical industry, he was very active in industry groups. He served on the PMA's Validation Advisory Committee and was chairman of the Computerized Systems Advisory committee where he wrote the original guideline on computer validation and negotiated its acceptance with FDA.
When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begi n with "I agree".
Objectives of the Presentation:
Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator esponsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects.Dr. Pierce has served as an advisor to several clinical research organizations.