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Workshop

cGMP Compliance for Quality Control and Laboratory Operations


Speakers: Kim Burson (Denali Therapeutics), Sandra Sandall (Genentech), Christina Schwalbe (Genentech), Alice Yee (Genentech), Brad Kumagai (Achaogen)
Organizers: Kim K. Burson, Shichang Miao
Date: 2018-11-01
Time: 8:45-17:15 Pacific Time
Registration fee (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor:
Vendor show vendors registered to date: (7)ACD/Labs; Analytical Lab Group; Averica Discovery Services; BioPharmEquip; Charles River Laboratories; JOINN Labs; R&D Systems
Registration: http://www.PBSS.org
Registration deadline:2018-10-30  (it will close sooner if the seating cap is reached)

About the Topic

This is a course to help pharmaceutical, biotechnology, medical device, and biologics professionals help to prepare and manage Quality Control Laboratories in a compliant, systematic, effective and skillful manner.  The course will go over key cGMP requirements for both the analytical and microbiological QC laboratories and include detailed information on the instrument qualification, QC sample management, method validations, data integrity and QC audits/inspection preparations. 

Topics Covered:

  • Relevant cGMP, ICH, USP and other Health Authority Expectations for QC Laboratories
    • Trends in Health Authority Findings Specific to QC
  • QC Instrumentation Qualification, Maintenance and Calibration
    • Risk Analysis on Equipment Types
    • USP requirements on Method Validation, USP <1058>
    • Qualification Requirements:  DQ/IQ/OQ/PQ
    • Computer Systems (21 CFR Part 11) and Audit Trails
    • Examples of Qualification for HPLC, Balances, FTIR, UV Spectrophotometer
  • QC Sample Management
    • Sample Receipt to Reconciliation
    • Logbooks and/or LIMS
    • Reference Standard Qualification and Oversight
    • Retention Sample Program
    • Sample Storage and Shipping
  • Key QC / QA Procedures and ControlsLaboratory OOS and OOT and retesting
    • QC Data Review and Data Management
    • Corrective and Preventative Actions (CAPA)
    • Change Controls
    • QC Reagent and Chemical Handling and Expiration Dating
    • Oversight of Contract Laboratory Organizations (CLOs)
  • QC Method Validations
    • Phase Appropriate Method Validation
    • Qualitative versus Quantitative
    • Compendial Qualification/Validation Guidelines
    • Training Requirements
  • QC Microbiology Laboratory Controls
    • Laboratory Set-Up
    • Media qualification and growth promotion
    • QC Microbiology Tests and Expectations
  • Health Authority and Audits of the QC AreasCase Studies throughout
    • Lab Walk-throughs
    • Data Integrity
    • Personnel Training Program
    • Stability Program
    • Inspection or Audit Checklists

Target Audiences:

  • Quality Control Analysts and Lab Supervisors
  • Data Reviewers
  • Analytical Scientists
  • Quality Assurance
  • Validation Specialists
  • Microbiologists
  • Qualification, Preventative Maintenance and Calibration Teams
  • Internal and External Auditors
  • Training Departments
  • 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 Quality Control and Quality Assurance, global inspection management (FDA, EMA, ISO and ROW), internal and external auditing and development and implementation of a global Pharmaceutical Quality System. 

Alice Yee, Ph.D. is a Senior Quality Product Leader at Genentech / Roche.  She has over 15 years of quality experience and has authored many Health Authority submissions specific for quality.  She is an expert in QC Methods Validation and participated in innovation and life-cycle management activities related to commercial physico-chemical methods across a global network under cGMP conditions.  She also has led work regarding assay trouble-shooting, method monitoring, transfer/training and re-development/re-validation of methods.

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.


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2019-10-03, Small-Molecule Bioanalytical Method Validation & Regulated Bioanalysis: Fundamentals, the New FDA Guidance and Regulatory Trends
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2019-11-12, Antibody Drug Discovery and Development: Hit Generation, Engineering, Cell-line Development, IND enabling studies, and Biosimilars
2019-12-10, In vitro Diagnostics and Precision Medicine
2020-02-11, Drug-Device Combination
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