FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
- Start Date:
- Thursday, 10 August, 2017
- End Date:
- Friday, 11 August, 2017 4:30pm
- Critical Care
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.The following steps to establish the appropriate manufacturing environment for phase 1 investigational drugs should be taken:A comprehensive and systematic evaluation of the manufacturing setting (i.e., product environment, equipment, process, personnel, materials) to identify potential hazardsAppropriate actions prior to and during manufacturing to eliminate or mitigate potential hazards to safeguard the quality of the phase 1 investigational drugReview the FDA recommendations and requirements for implementing a compliant program for the phase 1 clinical program.The following topics will be discussed to provide the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products.Course benefit:This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail.
Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.Learning Objectives:To gain an understanding of the requirements for drugs entering into phase 1 clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing manufacturing and quality strategies to meet FDA requirements.Areas Covered:Day 1 TopicsOverview of GMP requirementsGMP Requirements for a Phase 1 StudyPersonnel documentation and requirementsQC Function procedures and requirementsFacility and Equipment requirementsControl of components, containers and closures - methods and specsManufacturing & Records during phase 1 studies with an eye toward later developmentDay 2 TopicsVendor selection & managementProcess Validation to conduct for phase 1 clinical supply processSpecific requirements for various types of products: biologics, combinations, sterile productsMulti-product facilities considerationsPreparing relevant SOPs for early stage developmentProviding relevant information in the IND applicationWho will Benefit:DirectorsManagerSupervisorsLead workers in Regulatory Affairs Quality Assurance and Quality ControlWorkers who will prepare GMP documents for early phase productsWorkers who will review GMP documents for early phase productsNote: Use coupon code REFERRAL10 and get 10% off on registration.
DoubleTree by Hilton San Francisco Airport,
835 Airport Blvd,
Conference organized by ComplianceOnline
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality, under a code of ethics, and with process discipline to ensure greater shareholder returns.Keeping things simple and straight forward, so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.
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