Pharma Consultant, Pharma Expert

Jean-Yves PORRET

Consultant for the Pharmaceutical Industry

Jean-Yves Porret, Pharma Consultant

Profile

Family name

Porret

First name

Jean-Yves

Date of Birth

1957

Address

22 rue de la Plaine,
38610 Gieres - France

Telephone

Email

Web site

www.pharma-consultant.eu

LinkedIn

Career

• Present: Consultant for the Pharmaceutical Industry -

  www.pharma-consultant.eu

• 6 years : Head of the department “Customer Technical Support” at BD Pharmaceutical Systems, for supporting European Pharmaceutical Companies

• 5 years : Head of the Platform “Sterile Transfer System Technology” at BD Pharmaceutical Systems; many patents filed

• 6 years : Project Leader for process development and product development, at BD Pharmaceutical Systems

• 8 years : Project Leader and then Head of Technical Teams in Robotics for Industry




Education

• Master Engineering degree in mechanics & physics, ENSAM / Ecole Nationale Supérieure d'Arts et Métiers, Paris - 1980

• Master Engineering degree in mathematics & industrial software, ENSIMAG / INPG, Ecole Nationale Supérieure d'Informatique et de Mathématiques Appliquées de Grenoble / Institut National Polytechnique, Grenoble - 1984

• Other training sessions in recent years: 6 sigma, cGMP (Good Manufacturing Practices) 21 CFR 210 & 211, Quality system & ISO 9001, Quality System 21 CFR 820, Quality auditor, Clean room environment, Barrier isolation technology, Management & communication, English, Meeting efficiency, Promodel (process simulator), GAMP (Good Automated Manufacturing Practices), Validation of an isolator, Design control including functional analysis & risk management & FMEA (Failure Mode and Effect Analysis), PACE® (Product And Cycle time Excellence, a process for product development), SAP, Coaching & management, Selecting the best, Diversity, CRM (Customer Relationship Management, Voice of Customers, Pharmaceutical product inspection, Ethics, Confidentiality, etc …




Relationships

• French and English languages

• Large European network after 20 years in the pharma industry

• Close relationships with European machine makers, for example: B+S, Bosch Packaging, Brevetti, Corima Marchesini, Groninger, Inova Optima, Seidenader, etc …

• Has been a speaker at worldwide conferences such as PDA and ISPE. ISPE member.





Experiences on Pharmaceutical Processes

Missions carried out as Leader:

Expert procédés pharmaceutiques

I have

• Audited many PharmaCo production lines in Europe, when troubleshooting, in order to define the real cause(s) of non-quality regarding products or processes or procedures, and proposed solutions for curative and preventive improvements

• Introduced to the WW market an innovative in-situ packaging sterilization equipment for pharma production lines

• Supported and given advice to pharmaceutical companies, investing in a new machine or a syringe production line, for example for the choice of an equipment or a technology, process specifications, syringe compatibility requirements, design reviews, FAT (Factory Acceptance Test), etc…

• Managed several projects for equipment in clean environment, from specifications to validation stage, from manual to high speed automatic machines , from single assembly or inspection machines to complete lines

• Qualified and Validated an inspection machine, defined and executed IQ, OQ, PQ qualifications for equipment (Installation, Operational and Performance Qualifications)

• Educated and trained operators on global pharmaceutical processes

• Defined, put in place and validated a new procedure to optimize technical compatibilities between syringe products and pharma production lines

• Used GAMP (Good Automated Manufacturing Practices) quality methodology for process development

• Established DOE (Design of Experiment) to define key process parameters

• Managed or participated in process FMEA’s (Failure Mode and Effect Analysis).


Experiences on Pharma Products & Packagings

Missions carried out as Leader:

Pharmaceutical product expert

I have

• Developed a new sterile packaging directly connected to the filling isolator of pharma production lines (dozens of WW pharmaceutical laboratories are using this new packaging)

• Managed or participated in product and packaging risk analysis

• Defined product packaging specifications

• Optimized packaging shipping by plane, boat and truck

• Defined product test protocols, performed tests and associated reports

• Participated in equipment FAT and SAT, as a product and packaging expert

• Defined the necessary means to perform tests on products, developed them internally or bought them externally

• Analyzed technical issues on packaging, given diagnostics, and made recommendations for curative and preventive solutions

• Educated and trained operators on syringes and on medical devices

• Been in contact with a lot of packaging suppliers in Europe

• Analyzed, defined and validated different sterilization technics, in conformity with ISO norms, as gamma, beta, UV and EtO


Experiences in Quality

I have

• As quality auditor for 8 years, conducted quality audits of internal department and critical external suppliers

• Managed deviations, such as Customer complaints, or CAPA’s (Corrective Actions and Preventive Actions)

• Defined product, packaging and process specifications

• Been the "Technical Support" team Leader within the Customer Quality Department for 6 years

• Managed or participated in product and process FMEA’s (Failure Mode and Effect Analysis)

• Audited many PharmaCo production lines in Europe, when troubleshooting, in order to define the real cause(s) of non-quality regarding products or processes or procedures, and proposed solutions and curative and preventive improvements

• Established DOE (Design of Experiment) to define key process parameters and their settings

• Initiated and put in place an emergency procedure for high critical deviations

• Supported and given advice to pharmaceutical companies, investing in a new machine or a syringe production line, for example for the choice of an equipment or a technology, process specifications, syringe compatibility requirements, design reviews, etc…

• Defined product test protocols, performed tests and associated reports

• Used GAMP (Good Automated Manufacturing Practices) quality methodology for process development, including Functional Specifications, SDS, HDS, etc ...

• Qualified and Validated an inspection machine, defined and executed DQ, IQ, OQ, PQ qualifications for many equipment (Design, Installation, Operational and Performance Qualifications)

• Educated and trained operators on quality procedures and SOP's

• Defined, put in place and validated a new procedure to optimize technical compatibilities between products and production lines

• Participated in the implementation of the PACE ® (Product And Cycle time Excellence) method, used for product & packaging development projects within a quality system environment.


Experiences on Pharma Projects & Strategies

Missions carried out as Leader:

Pharmaceutical project expert

I have

• Defined and developed for the WW market a new technology for pharmaceutical production lines, technology used for inline sterilization at high speed of the outer packaging surface, feeding the filling isolator - Searched for suitable suppliers for prototyping - Conducted feasibility studies and then industrialization studies, and finally - Convinced dozens of WW pharmaceutical companies of the compatibility of this new process with standard products, so that they select and purchase this equipment

• Led a project to develop a new innovative packaging used for the sterile transfer of sterile products, - Filed many patents, and - Convinced dozens of WW pharmaceutical laboratories to select and buy this new packaging

• Participated in the implementation of the PACE ® (Product And Cycle time Excellence) method, used for product & packaging development projects

• Managed many purchasing projects and development projects regarding equipment for production lines

• Led a projet for traceability & quality improvement, through printers and camera control of data matrix and character recognition on batch number and expiration date

• Conducted quality audits of internal department and critical external suppliers, for 8 years

• Led a project for a semi-automatic auto-injector assembly line

• Convinced several well-known machine makers in competition with each other, to work together on the same project. Led this project, whose objective is to invent and develop an innovative equipment in order to improve the productivity of syringe filling lines. Tens of WW pharma production line are now equipped with this new system

• Led a project for implementing robots in a secondary packaging production line.