Laurence Richard Email and Phone Number

Vipharma is an audit and consulting company in the field of GxP quality assurance and vigilance.Through Vipharma, I share my experience, expertise and advice in the framework of French and European regulations for the benefit of:✔ Setting up and/or upgrading your quality systems✔ Optimising your organisation and processes✔ Conducting your audits

- Audits as a service for Life Sciences industries (human and veterinary drugs, cosmetics, medical devices): around 50 audits as a lead auditor all around the world according to the European and French good vigilance practices, good distribution practices, good manufacturing practices for parent companies, affiliates, PV partners, distributors, …- Preparation and contribution to authorities inspections- Preparation and contribution to customers audits - Writing of audit reports (in English and French), management of deviation and findings, CAPA follow-up, design and follow-up of quality indicators, design of a risk analysis to define an audit program, training, SOP writing- Setting up / upgrade of structures, optimisation of systems and processes- Development of the company: prospecting, reporting, elaboration of quote, participation to congresses, …- Lead speaker of events and trainings related to audits and PV

- Development of the unit "Audit Compliance Vigilances System": prospecting, reporting, elaboration of quote, participation to congresses, …- Lead speaker of events and trainings related to audits and PV- Quality Auditor

- Audits as a service for Life Sciences industries (human and veterinary drugs, cosmetics, medical devices): more than 30 audits as a lead auditor all around the world according to the European good vigilance practices, good distribution practices, good manufacturing practices for parent companies, affiliates, PV partners, distributors, …- Preparation and contribution to inspections - Preparation and contribution to customers audits - Management of deviation and findings, CAPA follow-up, design and follow-up of quality indicators, design of a risk analysis to define an audit program- Setting up / upgrade of structures, optimization of systems and processes

- Management of a team, member of the executive committee, writing/validation of procedures, supervision of the compliance of the system- Management of projects: - Redesign of the quality system: implementation of a quality policy, design of the processes and indicators of quality and performance, management reviews, design of the risks analysis for the external and internal audits, … - Back-up of the medical operation director for 4 months (supervision of a team of around 40 employees, board membership, …) - Project leader of the relocation of our office

- Internal audits and audits of suppliers (according to ISO 13485:2003, ISO 14155:2011, ISO 11137:2013, French directive 93/42/CE, 21CFR811, CMDCAS)- Medical devices of class Is and III (sterile delivery gun, sterile implantable synthetic bone substitutes), medical devices of class Is and III (sterile delivery gun and ancillaries, sterile implantable synthetic bone substitutes, combined medical devices)- Design (reviews and validation), manufacture, distribution on the European, American, Canadian and Brazilian markets- Validation of regulatory reports, management of deviations, findings and customer complaints, CAPA follow-up, management of products recall, Post Market Surveillance, design and management of risks analysis, design and management of processes mapping, management review, quality policy, release of products on the market, products quality controls, writing of procedures, qualification of equipment/calibration- Correspondent for medical device vigilance- ANSM and FDA inspections, management and resolution of crisis (sanitary policy, warning letter, unannounced inspections, …)- Member of the executive committee, team management, teamwork, …