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  • cGMP Workshop

  • Good Manufacturing Practices & Recent Inspection Findings for Human OTC Products Workshop

    November 12-13, 2018
    CHPA Headquarters
    1625 Eye Street, NW
    Suite 600
    Washington, DC 20006

    Our expert speakers include:

    Jennifer Ahearn

    Ms. Ahearn specializes in pharmaceutical and medical device regulatory compliance. She has served in numerous roles within the Food and Drug Administration (FDA) including bench chemist, domestic and international investigator, technical liaison for FDA’s Office of Criminal Investigations, and as a member of FDA’s National Training Cadre making her an expert in the interpretation and application of cGMP regulations in 21 CFR 210/211 relating to pharmaceutical manufacturing, and 21 CFR 820 relating to medical devices. Ms. Ahearn has assisted pharmaceutical and medical device companies preparing for FDA inspections, as well as responding to FDA 483 observations after an inspection. She has worked to resolve technical and FDA compliance issues for virtually all pharmaceutical dosage forms and medical device classes.

    Ms. Ahearn has worked with manufacturers with such aspects as sterility, material supply chain, vendor auditing, validation programs, laboratory and manufacturing investigations, laboratory and manufacturing audits, and CAPA implementation.

    Daniel Spankie

    Mr. Spankie specializes in pharmaceutical and medical device regulatory compliance and has over 19 years of experience in the fields of quality control, chemistry, regulatory compliance, analytical method development, data integrity, and validation.

    Mr. Spankie has successfully managed large quality organizations through warning letter and site remediation projects. In his role as Informatics Specialist, he helped design and implement Chromatography Data Systems (CDS), Scientific Data Management Systems (SDMS), and Laboratory Information Management Systems (LIMS) for both site based and global cGxP networks. He has extensive background in auditing and remediation of data integrity issues and has developed certification programs for data reviewers in regulated environments.

    Mr. Spankie focuses on providing compliant, robust, and efficient solutions and processes for validation programs, laboratory and manufacturing investigations, laboratory and manufacturing audits, and data integrity audits and training.

    Who should attend?

    This seminar is open to CHPA members.

    Agenda

    Monday, November 12th

    10:00 a.m. – 5:00 p.m.

    Tuesday, November 13th:

    8:30 a.m.-12:30 p.m.

    For detailed agenda information click here

    Registration Information:

    CHPA Member price: $99

    Register Online

    cGMP Workshop Registration Form

     

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