Thomas Altmann

Technical Consultant & Validation Manager, EU Pharma

Thomas is a cleaning chemistry, cleaning process, cleaningvalidation and regulatory compliance subject matter expert.

Thomas has 23 years' experience as a technicalconsultant providing consultation on cleaning processoptimisation for pharmaceutical, API, biotechnologyand cosmetic/personal care manufacturers in Europe,Middle East, Asia Pacific and Africa.

He is an expert in cleaning validation for productcontact surfaces across all types of pharmaceuticaland personal care production equipment. He isexperienced in addressing regulatory inspectionfindings related to cleaning processes – and withimplementing CAPA plans to prevent re-occurrence.

Thomas has developed more than 1500 cleaningprograms/recommendations for pharmaceutical andpersonal care industries over the past five years.

He regularly contributes to presentations andworkshops for thought leading and standard-setting organisations: ISPE (International Society ofPharmaceutical Engineering), Informa LifeScience,VDMA and FDANEWS.

Thomas contributed to the ASTM E55 Cleaning TaskGroup (ASTM Sciences and Risk-based Cleaning Processdevelopment and Validation) and published relatedarticles as a co-author in "Pharmaceutical Engineering"as well as "Pharmaceutical Online" and "BiotechnologyOnline". Prior to joining Ecolab, Thomas worked in thehealthcare/pharmaceutical and food industries.

Igor Gorsky

Pharmaceutical, Biopharmaceutical and Medical Device Industry Professional

Igor Gorsky has been a pharmaceutical, biopharmaceutical and medical device industry professional for over 39 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire where he oversaw global validation efforts, including Analytical Methodology, Equipment and Facilities Qualification, Process, Packaging, Shipping, Computer and Cleaning Validation and Environmental Monitoring Programs. He is currently holding a position of Senior Consultant at Valsource, LLC. His over the years accomplishments include validation of all of the aspects of pharmaceutical, biotechnology and medical device production and quality management, technical support of multi-billion-dollar drug product lines and introduction of new products onto the market. He developed Analytical Technology Policies, Procedures and Master Plans for numerous biopharmaceutical firms based on latest global regulation.

He also developed Analytical Technology qualification programs for a number of pharmaceutical and biopharmaceutical firms. He published numerous articles and white papers in pharmaceutical professional magazines. He is an author of two books on Pharmaceutical Scale Up and Process Validation. In addition, he had been a presenter at PDA Annual Meetings, Interphex, UBM International Workshops and other forums. He is also very active with PDA and ASTM participating in several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation), 60 (Process Validation), 60-2 (Process Validation Annex 1: OSD and SSD Dosage). He is leading PDA Water Interest Group. He also is a member of ASTM E55, authoring ASTM E3106-18 Science and Risk Approach to Cleaning Validation, as well as several other standards (ASTM E3219, E3263, G121, G122). He holds a BS degree in Mechanical/Electrical Engineering Technology from Rochester Institute of Technology.

Vivek Gera

CEO, CLEEN

Vivek Gera is the CEO of Leucine, building the No-Code platform for compliant & audit-ready drug manufacturing.

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Vivek has worked on multiple high-value manufacturing automation projects during his 10+ years of work experience across regulated industries such as Pharma, Medical Devices, and Mining.

Vivek completed his bachelor's in Chemical Engineering and Masters's in Process Control from IIT Kanpur where he published multiple research papers across reputed peer-reviewed journals.

Dr. Rajiv Desai

Advisor & Former EVP – Corporate Quality, Lupin

VIndustry:

• Since July 2022, working at Lupin as an Advisor, Corporate Quality and as Senior Technical Advisor at the Indian Pharmaceutical Alliance (IPA)
• Earlier worked as Executive Vice President, Corporate Quality at Lupin Limited between June 2016 to June 2022 responsible for API, Formulations (OSD, Injectables, Biotech) and Development Quality Assurance
• Experience of working in the Pharmaceutical Industry for over 34 years
• Worked as Head of Corporate Quality Management at Lupin, Dr Reddy’s, Mylan, Alembic, Orchid and Dishman
• Worked in Quality Management, Basic Research, Process Development, Analytical development, and Regulatory Affairs
• Worked extensively on Project management, Technology Transfers and Automation programs
• Involved with projects with several Pharma MNCs for Regulated markets
• Worked in India, Switzerland, and China. Collaborated with companies in several geographies around the world.
• Involved in implementation of best practices in the industry for Quality and productivity improvement.
• Experience and involvement in Regulatory inspections by USFDA, MHRA, EDQM, WHO, PMDA, ANVISA, COFEPRIS, TGA, Kosher and ISO certifications
• Conducted Due Diligence for mergers and acquisitions
• Recipient of the Chairman’s Excellence Award for best Quality Management and Best Customer retention Initiative at Dr Reddy’s Laboratories.
• Invited for technical presentations at national and International conferences, seminars, and workshops.
• Member of US Pharmacopeia Expert Committee (2010 – 2015)
• Member of Indian Pharmacopoeia Expert committee
• Active member of Indian Pharmaceutical Alliance (IPA) since its inception. Worked on several guideline publications, seminars, and workshops as a key representative of the Pharmaceutical Industry.
• World Quality Congress Award for one of the top 10 Quality Professional in the country in 2014 and one of the top 50
• Influential Quality Professional in 2015 across the industries.

Academics:

• Selected as a visiting faculty at UDCT under an Daichi Karkaria Endowment faculty program for year 2013.
• Nominated as Industry expert Supervisor at JNTU, Andhra University
• Nominated as Industry expert at Nirma University, Ahmedabad for mentoring postgraduate and Ph D students.
• Faculty at the M. Tech (Pharma) post graduate program in collaboration with BITS, Pillai sponsored by Dr Reddy’s Laboratories.
• Visiting faculty at M S University Vadodara for imparting lectures on Quality Management for post graduate programs
• Invited to deliver keynote address at the International Conference on Quality Management at IIM, Ahmedabad
• On the Board of studies at three chemistry and Pharmacy colleges in Mumbai for Syllabus setting and Students programs

Qualifications:

• Ph. D (Pharmaceutical Chemistry) 1989, Topic: ‘Studies in the Chemistry of Phthalides’ Under the supervision of Prof. S.D.Samant, Professor, Applied Chemistry Department at University Department of Chemical Technology (UDCT), Mumbai, INDIA. Scholarship by Govt. of Maharashtra, INDIA
• M.Sc. (Organic Chemistry) University of Mumbai 1984
• B.Sc. (Chemistry) University of Mumbai 1982
• M.A.M. (Master’s in Administration Management) 1992 – 1995 (Three years post‐graduate degree course conducted by the University of Mumbai at Narsee Monjee Institute of Management Studies (NMIMS), Vile‐Parle, Mumbai)

Mr. A V Jayakumar

CEO, CLEEN

Mr. A V Jayakumar has completed his master's in analytical chemistry from Sardar Patel University, V V Nagar Anand. He is a senior quality and compliance professional with over 25 years of experience. He started his career with Torrent and subsequently with Cipla, Aurobindo, USV, and Glenmark. At present, he is responsible for the global quality operations of Ajanta Pharma Ltd.

He has expertise in evolving sites from scratch to meet all SRA compliance requirements. He also has expertise in delivering training and has conducted several audits in India and overseas.

During his career, he dealt with all stringent regulatory authorities during inspections, preparing responses and their ongoing compliance program.

Sridhar Balasubramanian

Independent Consultant

Sridhar is an industry thought leader & strategic organizational transformation expert catalyzing “Quality as a competitive advantage” to enable larger business and patient outcomes. Passionate on Digitalization & leveraging technology and applying the principles of Industry 4.0 to Pharma 4.0.

A Progressive, Innovative and Performance oriented professional with proven leadership capabilities, keen customer centric orientation and entrepreneurial mindset; with over 26 years of Pharmaceutical Management experience using the learning from Quality & Operations Management across GxPs.

Develop and implement transformational strategies to ensure a culture of Quality, Compliance, Sustainability, Operational & Process Excellence using the principles of Risk Management, Change Management & Project Management. Implementing & leveraging digital technology and analytics for enhancing functional and business capabilities for faster, objective and risk-based decision making.

Expertise acquired through roles of increasing responsibility based in India & USA with span of responsibility across India, Asia Pacific, USA & EU regions; in a highly regulated environment for high volume/value, pharmaceutical products (OSDs, Sterile/ injectable, inhalation, APIs, biologics etc.), spanning Manufacturing, R&D, Commercial and Corporate functions etc. in varying business models.

He has successfully lead several regulatory inspections of USFDA, MHRA, MCC, TGA, ANVISA, EU countries and demonstrated continued compliance to CFRs, cGMPs, cGCPs, cGPvPs, CPSIA, SUPAC, ICH, EMEA guidelines, and practices, etc. Exposure to international markets such as the US, UK, EU, and other countries from a Quality & Compliance perspective. Demonstrated ability to build complete end – to – end Quality systems in support of “Ideation to Commercialization” for both internally and externally developed and manufactured products and; in/across manufacturing facilities serving diverse global markets, compliance across GxPs (GMP, GCP & GPvP) & leveraging and practicing.

In his current role, Sridhar is the Head Quality Operations for Stelis Biopharma leading a large team across multiple sites, for sterile fill finish& biological products. Previously, he has worked with several organizations such as Biocon,Novartis, Dr Reddy’s, Orchid & Cipla; as well as being an independent consultant.

Mahesh Saini

Head Quality Assurance-Sun Pharma

Mr. Mahesh is Post Graduate in Microbiology and has extensive experience as a Lead in Quality Operation and Quality Compliance in Pharma, Biopharma, and related industries.

His experience includes Quality Management, Qualification & Validations, Technology Transfer, Quality Operations, Sterility Assurance, Audit & Compliance, and Training.

He has been engaged in numerous Audits, Greenfield projects, Remediation activities, and Quality improvement projects.

He is Senior Quality Assurance Manager at Sun Pharma and has spent around 18 years with Pharma, most recently as Lead, Quality in Mylan Laboratories & Cipla Ltd. before joining Sun Pharma 5 years ago.

Dr. Kuldeep Sharma

Sales Development Manager-Agilent Technologies

Kuldeep Sharma has over 21 years of experience in the area/s of Analytical R&D, Drug metabolism & pharmacokinetics, and Pharma regulatory compliance. He holds a Doctorate of Philosophy in Biotechnology. His professional journey covers a true blend of Technical and Commercial industry insight with over 13 years in Analytical research (Working with Zydus Cadila, Lambda, Pliva, and Jubilant Biosys R&D centers) and the last 8 years in the Analytical instruments sales and marketing field (with Waters & AGILENT Technologies). During his industry experience, he had accomplished leading roles in domains covering the conduct of Analytical research, Pharma quality compliance, Pre-Clinical (Pharmacokinetics and Toxicokinetics studies, In-Vitro assays, Tissue distribution, and In-Vivo metabolic profiling), and Bio-analytical studies. With over 21 research articles published in international Journals, He presents a convention of continuous learning enabling him to acquire certifications of Lean Six Sigma-Black Belt and MBA (Operations Management) in continuation to his professional journey.