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David Haggard is a GMP Regulatory Consultant at David Haggard Associates, LLC at David Haggard Associates, LLC. He possess expertise in gmp, pharmaceutical industry, sop, 21 cfr part 11, validation and 29 more skills.
David Haggard Associates, Llc
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Managing Gmp Regulatory ConsultantDavid Haggard Associates, Llc Jan 2012 - PresentLower Gwynedd, Pa (Usa)Leads consulting practice offering auditing, training and advising to small, medium and large pharmaceutical firms to improve their internal and external auditing programs to drive effectiveness and efficiency into organizations; assist in investigation / evaluation of manufacturing deviations and evaluation of corrective actions; prepare responses to regulatory observations; and delivers GMP presentations to help the auditors, operators and managers throughout the pharmaceutical industry develop or maintain a GMP culture based on an understanding of the requirements.For additional information on qualifications, experience and a CV, please use the link above to go to company website.
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Sr. Director, Divisional Gmp AuditingMerck Co., Inc. Sep 2003 - Nov 2011Implemented a series of improvements involving organizational design, customer focus and training to increase effectiveness and reduce audit program cost by more than 40%. Integrated GMP, Automation, Data and corporate US based central audit groups into a single organization with personnel worldwide in 13 countries. Established a diversified multilingual auditor base to increased effectiveness and reduced travel cost. Implemented a risk-based model to decide the audit frequency schedule based on more than 11 risk factors, resulting in reducing resources spent on low risk suppliers and opportunity to focus existing resources on the highest risk suppliers. Focused audits on identifying significant regulatory risks and identifying opportunities for site efficiencies. Mentored auditors on developing focus on explaining regulatory basis for observations, allowing sites to decide on best corrective actions driving mutual respect and efficiencies. Led and participated in audits on a regular basis to teach / evaluate auditors and assist sites. Created 200+ page user-friendly training manual with emphasis on teaching intent, understanding and focus of regulatory inspections for GMP. Started a competency-based auditor certification program that included written, oral and observing auditing skills as criteria for certification. Served as an expert on FDA subjects and represented Company at external conferences including being a Board member for Rx-360, a consortium of members from the pharmaceutical industry and 3rd party suppliers. -
Director, Worldwide Gmp Policy And Compliance ProgramsMerck Co., Inc. Jun 2001 - Sep 2003Created and improved along with managing the development of cGMP policies, guidelines and SOPs. -
Director, Division Of Compliance Policy (Last Position)U.S. Food And Drug Administration Jun 1968 - Jun 2001Rockville, MarylandU.S. Food and Drug Administration experience: • Investigator, Baltimore, MD and Richmond, VA• Resident-in-Charge, Norfolk, VA• Supervisory Investigator, Buffalo, NY• Director of Inspection Branch, San Juan, PR• Director, Investigations Branch, Rockville, MD• Director of Compliance Policy, Rockville, MD
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Frequently Asked Questions about David Haggard
What company does David Haggard work for?
David Haggard works for David Haggard Associates, Llc
What is David Haggard's role at the current company?
David Haggard's current role is GMP Regulatory Consultant at David Haggard Associates, LLC.
What is David Haggard's email address?
David Haggard's email address is da****@****zon.net
What is David Haggard's direct phone number?
David Haggard's direct phone number is +121523*****
What schools did David Haggard attend?
David Haggard attended University Of Maryland College Park.
What skills is David Haggard known for?
David Haggard has skills like Gmp, Pharmaceutical Industry, Sop, 21 Cfr Part 11, Validation, Capa, Regulatory Affairs, Change Control, Pharmaceutics, Technology Transfer, Quality System, Regulatory Submissions.
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David Haggard
Project Manager /Estimator At Capital Electric Line BuildersKansas City Metropolitan Area -
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