|
Overview: Because certain requirements in 21 CFR part 211, which implement § 501(a)(2)(B) of the FD&C Act, were directed at the commercial manufacture of products typically characterized by large, repetitive, commercial batch production (e.g., those regulations that address validation of manufacturing processes (§ 211.110(a)), and warehousing (§ 211.142)), they may not be appropriate to the manufacture of most investigational drugs used for phase 1 clinical trials. FDA has issued regulations governing IND products to protect human subjects enrolled in clinical trials. For example, in 21 CFR part 312, sponsors must submit chemistry, manufacturing and control (CMC) information on a drug or biological product as part of an IND application (§ 312.23(a)(7)). FDA reviews the submitted IND to determine whether the phase 1 investigational drug to be used in the clinical trial is sufficiently safe to permit the trial to proceed. This determination is based, in part on whether the investigational product has the identity, strength, quality, and purity, and purported effect described in the IND application. In certain circumstances, FDA also may choose to conduct an inspection (e.g., if there is insufficient information to assess the risks to subjects or if the subjects would be exposed to unreasonable and significant risk). Finally, FDA could decide to place a proposed or ongoing phase 1 clinical trial on clinical hold or terminate the IND. FDA can also take any of these actions if there is evidence of inadequate QC procedures that would compromise the safety of an investigational product. Why Should You Attend :To gain a fundamental understanding of the cGMP strategies for implementation and compliance for Phase I Investigational Drug and Biologic products Areas Covered in the Session Personnel Quality Control Facilities and Equipment Components, Containers, and Closures Recordkeeping Sterility Who Will Benefit: Regulatory Affairs Research and Development Clinical Research professionals Investigators Regulatory professionals working in the medical device field Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia. Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Event Link - http://bit.ly/1joixzR
Related Articles -
Iso 13485 Design, Sox Compliance Training, Design History File, compliance training, Medical Device Training 510(K) Compliance Training, 510(k) Webinar,
|
