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Workshop

Preparation for Inspection by Regulatory Authorities (FDA, EMA, etc) and Resolution of Outcomes: A Guide for Drug Development and Commercialization


Speakers: Kim Burson & Elizabeth Marsie-Hazen (Achaogen)
Organizers: Kim Burson (Achaogen)
Date: 4/24/2018
Time: 12:45-17:00
Registration fee (USD): Regular: $125; Academic: $75; For unemployed or students: $25; For vendor-show reps: $25; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor:
Vendor show vendors registered to date: (1)Sekisui XenoTech, LLC
Registration: http://www.PBSS.org
Registration deadline:4/23/2018  (it will close sooner if the seating cap is reached)

About the Topic

This course intends to help pharmaceutical, biotechnology, medical device and biologics professionals help to prepare and manage health authority inspections in a systematic, effective and skillful manner.  Preparing for health authorities inspections cannot be underestimated.  Negative outcomes can delay product approvals and can be financially devastating.  Whether you are preparing for your first inspection or fine tuning your current inspection or audit readiness programs, this course will enable confidence and equip your company for a positive outcome. 

Topics Covered:

  • History, trends and types of inspections
  • Inspection Outcomes
  • Training (Do’s and Don’ts and interviewing techniques)
  • Set-up and roles and responsibilities of the inspection room and back office (WAR room)
  • Pre-work – quality systems, documentation, tours, mock inspections
  • Replying to observations (483’s, Warning Letters, inspection non-compliances)
  • Case Studies


Target Audiences:

  • Quality Assurance
  • Quality Control and Laboratories
  • Internal and External Auditors
  • Regulatory Affairs
  • Compliance Officers
  • Senior Management
  • Cross-functional Teams

About the Speakers

Kim K. Burson, Ph.D. is the Head of Quality at Achaogen, Inc.  She has over 20 years of experience in the pharmaceutical, biotechnology and medical device industries.  Her global background includes both clinical and commercial products and tenure at Genentech, Roche in Switzerland, Millennium Pharmaceuticals and two medical device companies.  Kim’s areas of expertise include global inspection management (FDA, EMA, ISO and ROW), internal and external auditing, the Pharmaceutical Quality System, Quality Assurance and Quality Control. 

Elizabeth Marsie-Hazen currently heads GMP Compliance at Achaogen.  She has over 25 years of experience in the biotechnology and pharmaceuticals industry including tenure at Genentech and Bayer.  Her career spans process development, technical transfer, facility start-ups, heading manufacturing, quality compliance and technical regulatory.  The last 18 years of her career has been primarily focused on compliance and inspection preparation programs and activities including routine GMP and pre-approval inspections by FDA, EU and ROW Health Authorities.


2018-09-27, Small Molecule Formulation Development: Strategies for challenging APIs (jointly with AAPS-BADG)
2018-10-16, Drug-Drug Interactions: Update on Risk Assessment, Clinical Evaluation, and Regulatory Requirements
2018-11-01, cGMP Compliance for Quality Control and Laboratory Operations
2018-11-16, Protein therapeutics and biomarkers: Recent developments in characterization and quantification by hybrid LC-MS
2018-12-04, Challenges in Peptide Drug Discovery & Development: Biology, Chemistry, PK, Delivery, Regulatory and Beyond
2019-02-07, Covalent Inhibitor Drug Discovery & Development: Biology, Chemistry, PK, Safety and Case Studies
2019-03-07, Promising therapeutic approaches and transnational medicine from SPARK: an academic-industry collaboration to advance novel therapeutics (A Joint Symposium by PBSS and Stanford SPARK Program)
2019-03-11, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
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