Joseph Famulare, Genentech, a Member of the Roche Group, United States
I am currently the Global Head of Compliance and External Collaboration. I am responsible for the company's internal audit program, inspection management, and health authority relations and policy. I have worked 32 years in the FDA in CDER's Office of Compliance and in the field organization.
Currently: member of the Int’l Drug Inspection Cadre; Team Leader and Acting Branch Chief at CDER Office of Compliance, Division of Manufacturing and Product Quality, Int’l Compliance Branch; Invited Professor at the PR University School of Law, (course on Federal Regulations enforced by the FDA).
Carmelo Rosa has not provided this information at this time
Ian Jackson, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
He joined MHRA in Aug 05 as a GMP Inspector and is now a Senior Inspector. Appointed Operations Manager within the GMP inspectorate in Sept 08 and is also responsible for GMP inspection planning. Prior to joining the Agency he worked in the Pharma industry for 12 yrs.
Elaine Eborall, Genentech, a Member of the Roche Group, United States
Description
A robust pharmaceutical quality system includes a well thought-out auditing program for self audits of contract manufacturing organizations, suppliers and their distribution chain. This provides senior management key information to ensure quality.
Learning Objectives: Define auditing practices that are critical to product quality utilizing principles of quality risk management Describe how auditing practices will help to maintain the control strategy and mitigate risks of adulteration.