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Preparing the CMC Section for NDAs/INDs/CTDs

  January 19, 2018  
CfPIE - The Center for Professional Innovation & Education, Malvern, PA USA
May 21 & 22, 2018

Course Description Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This course includes an overview of the International Conference on Harmonization (ICH) process and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of NDAs and INDs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, and pharmaceutical development reports. It will also discuss the use of Drug Master Files (DMF) and preparation of the CTD Quality Overall Summary (Module 2).

Who Should Attend

This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND and for personnel who are not involved in CMC document preparation but want an overall understanding of what is involved for both the drug substance and drug product.

Please note: This course covers the requirements for synthetic, small molecules and does not address biologics.  Biologics are addressed in our course "CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics"

Organized by: Center for Professional Innovation & Education
Invited Speakers:

Maria A. Geigel

Specialties: Regulatory

Maria A. Geigel is an independent consultant with MAG Associates, LLC. Her primary area of expertise is in regulatory affairs for Chemistry, Manufacturing and Controls (CMC). This experience covers synthetic active ingredients and all types of dosage forms.

With over thirty years of industry experience, she has prepared CMC sections of DMFs, INDs, NDAs, ANDAs and European Community dossiers – the most recent of these in CTD format. She has also developed regulatory strategies for worldwide registrations; assisted companies with complex regulatory/compliance issues and interacted with chemical and pharmaceutical manufacturing facilities to assure preparation of approvable submissions.

Prior to consulting, Ms. Geigel held various positions in Regulatory Affairs at Syntex (now Roche) and was Director of Technical Regulatory Affairs and Laboratory QA at Janssen Pharmaceutica. In addition to her CMC experience; Ms. Geigel is also versed in Quality Assurance and has evaluated manufacturing and analytical facilities, defined Standard Operating Procedures (SOP), prepared facilities for inspection, provided GMP training and responded to numerous observations from the FDA.

Ms. Geigel – bilingual in English and Spanish – received her M.S. in Organic Chemistry from the University of Colorado and her M.B.A. in Management from Golden Gate University.

Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=248
E-mail: info@cfpie.com
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