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Contamination Control Strategy

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COMPASS by FAMAR participated in the ๐Ÿฐ๐˜๐—ต ๐—˜๐˜…๐—ฐ๐—ฒ๐—น๐—น๐—ฒ๐—ป๐—ฐ๐—ฒ ๐—ถ๐—ป ๐—–๐—น๐—ฒ๐—ฎ๐—ป๐—ฟ๐—ผ๐—ผ๐—บ ๐—ข๐—ฝ๐—ฒ๐—ฟ๐—ฎ๐˜๐—ถ๐—ผ๐—ป๐˜€, ๐—ค๐˜‚๐—ฎ๐—น๐—ถ๐˜๐˜† ๐—”๐˜€๐˜€๐˜‚๐—ฟ๐—ฎ๐—ป๐—ฐ๐—ฒ & ๐—–๐—ผ๐—ป๐˜๐—ฟ๐—ผ๐—น ๐—ณ๐—ผ๐—ฟ ๐—ฃ๐—ต๐—ฎ๐—ฟ๐—บ๐—ฎ & ๐—•๐—ถ๐—ผ๐˜๐—ฒ๐—ฐ๐—ต on 28th and 29th of September, in Berlin Germany.

Our expert Alicia Ruiz Mahillo was a key speaker on the pertinent subject of Contamination Control Strategy (CCS).

Author:
COMPASSbyFAMAR
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Copyright ยฉ 2023 COMPASS by FAMAR

Copyright ยฉ 2023 COMPASS by FAMAR

Faidra Angelikaki

Faidra is a Pharmaceutical Process & Cleaning Validation expert with over a decade of experience in the manufacturing industry and pharmaceutical technology focusing on process optimization and process excellence. She is a Chemical Engineer by academia with Master degree in Industrial Pharmacy. She has strong scientific knowledge in all pharmaceutical dosage forms, deep understanding of Pharmaceutical Technical Operations and regulatory expectations. Her industrial experience and continuous improvement mentality, reinforce her drive to impact quality compliance and operational efficiency projects in the pharmaceutical sector.

Alexandros Trompetas

Alexandros is a Pharmaceutical Quality Operations professional with more than 15 yearsฮ„ experience in the field of Technical Quality Assurance, Laboratory operations and Quality control systems.ย 

He is a Chemist by academia, with a comprehensive knowledge of Pharmaceutical Quality Systemsโ€™ design, cGMPs, Compendia and industrial Guidelines, leveraging this knowledge to excel in multiple professional capacities within Manufacturing Operations and Quality Assurance. He has extensive experience in auditing, CAPAs, digital transformation, and regulatory compliance. He is also skilled in analytical methods validation and troubleshooting, data integrity, lean lab, quality risk management, and computerized system validation.

Theoni Sarri

Theoni is a Pharmaceutical Quality professional with more than
17 yearsฮ„ experience in Quality Assurance, Regulatory Compliance and Laboratory Operations in various management positions, including Head of Quality Management for over 7 years.

She is a Chemist by academia and she holds a MSc in Biochemistry.

She has a strong knowledge of Quality Management Systems to EU GMP regulations, as well as Cosmetics, and has been a Qualified Person for over 14 years.

Alicia Ruiz Mahillo

Alicia is a Pharmaceutical Quality Professional with more than 20 yearsโ€™ experience in Multinational Pharmaceutical Companies for several markets (EMA, FDA, PMDA, TGA). Experienced in Quality Assurance, Quality Control and CMC from development & clinical phases to commercial stage. She is an SME in Microbiology for API & Medicinal Products (Sterile & non-sterile).

She was a graduate in Biochemistry and Molecular Biology (UAM), and after acquiring investigational background and doctorate studies (Severo Ochoa Molecular Biology Center, CBMSO), her carrier was developed in Multinational Pharma companies.

Maria Dova

Maria is a Chemist by academia and a Pharmaceutical Quality professional with more than 18 yearsฮ„ experience in Multinational Pharmaceutical Industries in QC, QA and R&D departments. ย 

She has a full understanding of supplier compliance regulations, with a strong knowledge of creating functional supplier management systems to cGMP regulations.

She is a Lead Supplier Auditor with over 9 yearsโ€™ experience in compliance assessment standards such as EU GMP Part II, ISO 9001, ISO 17025, ISO 15378 etc.

Extensive expertise in Data Integrity aspects according to FDA and EU guidelines, with a track record of leading involvement in Data Integrity projects for over 3 years.

Anastasia Dreliozi

Anastasia is a Quality professional with more than 25 yearsฮ„ experience in Regulatory Compliance, Research and Development, Regulatory Affairs, and served as a QP for more than 15 years. She has extensive hands-on experience on developing and implementing regulatory strategies that achieve compliance with government regulations.

She is a Chemist by academia and she holds a MSc in Pharmaceutical Analysis and Quality Control.

Katerina Karapa

Katerina is a Pharmaceutical Quality Operations professional with more than 25 yearsฮ„ experience in Technical Quality Assurance, Regulatory Governance and Compliance, Laboratory Operations and design of integrated Quality Management Systems.

She is a Chemist by academia with a M.Sc. in Analytical Chemistry from Northeastern University (US). Recently she acquired an Executive MBA from ALBA Graduate Business School (GR), reinforcing her drive of integrating Quality Management Systemsโ€™ design into business strategies and organizational structures.

Kiki Melissourgou

Kiki is a Group Quality Systems expert in Pharmaceutical Industry with more than 20 years of experience in Quality Control, Quality Assurance and Inspections Management. She has a BSc degree in Biomedical Sciences and a Master Degree in Business Administrations (MBA).

Kiki has a wide knowledge on applying digital solutions on integrated quality management systems in cross functional organizations, designing and cascading strategies on people development through Training Academy programs, continuously monitoring quality systems & operations surveillance by inspections and transforming agile KPIs into OKRs, Objectives & Key Results.

Pedro Moreira

Pedro is a Pharmaceutical Qualification Operations professional with more than 20 yearsฮ„ experience in Technical Areas, Engineering and Quality by design, specific to Buildings/Facility; Utilities and Equipment/Instrumentation Systems.

He is a Mechanical Engineer by training from the Engineering Institute of Lisbon, Portugal and has been working at several Pharma & Biotech companies around the Europe, as: Portugal; Ireland; UK & Netherlands, which gave him the opportunity to have a multicultural experience as well as professional.

During his first professional years, Pedro was part of the Engineering teams and at the last 6 years has been taken part of Quality departments.

Antonia Mousouraki

Antonia is a Quality Assurance & Systems professional with over 12 years of experience and a demonstrated record of contribution on designing structural schemes of system of written procedures. She is committed and passionate about helping pharmaceutical organizations and people to meet their full potentials. She has led multi-disciplinary transformation projects, managed cross-functional and diverse teams to meet the organizational operational objectives such as operational
excellence, preventive compliance, inspection readiness, designing,
implementing and improving quality management systems.
She is a Chemist by academia and she holds a MSc in Analytical Chemistry.