Organizations must have inspection readiness since inspections can be unannounced or come at any time. Good Clinical Practice (GCP) inspectors use different approaches depending on the regulatory authorities for which they represent; however, all of them will verify the compliance status on GCP and other applicable regulations during the inspection.
Planning ahead to anticipate all processes are compliant means an organization is prepared for an inspection and able to create a solid corrective action and preventative action (CAPA) to minimize risk.
Join this webinar where Ernesto Vera-Sanchez, MD, PhD, Vice President of GxP Consulting services at Allucent, discusses the ins and outs of preparing for regulatory authority inspections during a drug’s life cycle.
Dr. Ernesto Vera-Sanchez, MD, PhD, Vice President, GxP Strategy Consulting Services, Allucent
Dr. Ernesto Vera-Sanchez, MD, PhD, has 20 years of global regulator and inspectorate experience as a Head of Inspectorate for GCP, PhV and GCP/GLP, at the Ministry of Health Spanish Agency of Medicines and Medical Devices (AEMPS). Ernesto has exceptional expertise in legislation and compliance for clinical trials, Pharmacovigilance and GCP/GLP. His regulatory experience as Expert Inspector involved conducting over 400 worldwide inspections at Sponsors, CROs, vendors and clinical investigators sites for the EMA and AEMPS. He has worked since the beginning of the FDA-EMA GCP initiative in 2009, being one of the first EU inspectors attending BIMO training and joining FDA representatives in several observational and join inspections as well as in different meetings, trainings and conferences as well as with other EU inspectors. Ernesto has trained inspectors from Regulatory Authorities across Latin America and Asia in different disciplines related to GCP, PhV and GCPGLP.Message Presenter
Who Should Attend?
Managers and above at biotech companies with job functions and oversight of the following areas:
- Regulatory Affairs
- Project Management
- Clinical Operations
- Clinical Research
- Medical Affairs
- Quality Assurance
What You Will Learn
Webinar attendees will gain insights into:
- Understanding inspection readiness from a regulatory agency standpoint for Good Clinical Practice (GCP)
- Knowing how an inspection is conducted including important processes for which to be prepared
- Overcoming challenges in preparing for an inspection with regulatory obligations
- Preparing an effective corrective action and preventative action (CAPA) to solve deficiencies detected during inspections and avoid them in the future
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.