Right First Time - Quality in Manufacturing
Date - 23rd and 24th of March 2017
Venue - Novotel Hotel, Pune
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This interactive workshop intends to provide practical insight into Right First Time for vaccines and biologic manufacturing. The topics for deliberations are chosen across the domains of scale up, manufacturing, data review, quality risk management and quality operations. The cold chain distribution is critical in supply of vaccines & biologics and hence finds a reference point in the workshop.
- Understand regulatory expectations for Vaccines & Biologics
- Provide clarity on good documentation practice, review practices and cases of data integrity in biologics and vaccines
- Managing post approval changes based on the draft ICH Q12 in vaccines and biologics manufacturing
- Practical approaches for Quality Risk Management in vaccine and biologic manufacturing
- Learning approaches for deviation management & investigation in manufacturing line
- Challenges of cold chain distribution
Who Should attend
Target Audience would be individuals from teams from Regulatory, Scale up/Technology Transfer, Manufacturing, Quality Control, Quality Assurance operations, who will benefit from the experience that speakers will share.
To increase the
interactions during the workshop and to have maximum learning there are only limited seats so block your seat at the earliest .
Download the attendee registration form here
OR Call or email the India chapter for details and to register
tel. 91 80 23506562
Thursday, March 23, 2017
Session Time and Title
|8.15 a.m. - 9.00 a.m. Registration Opens
|9.00 a.m. - 9.30 a.m. Welcome & Opening Remarks
|9.30 a.m. - 10.15 a.m.
Necessity for Right First Time - Quality in manufacturing operation
| This session highlights the importance of complying to cGMP from the first time and how this leads to building a quality manufacturing operation
|10.15 a.m. - 10.30 a.m.
|10.35 a.m. - 11.20 a.m.
Session 1: A primer on varying scale manufacture of Vaccines & Biologics
| This session addresses the challenges that one faces during the scale up operations and discuss a few strategies that have been used in vaccines
|11.25 a.m. - 12.10 p.m.
Session 2 : Regulatory expectations for Vaccines & Biologics
| This session leads to highlight regulatory expectations to be met and followed from the local and select global regulatory agencies
|12.15 p.m. - 1.30 p.m.
Session 3: Good documentation & review practices
| This session leads to discussion on the good documentation & review practices to be considered with a case study discussion
|12.15 p.m. - 12.50 p.m.
Good documentation practices & Data Integrity in Manufacturing - A case study for
|12.50p.m. - 1.30 p.m.
Good review practices for Biologics Manufacturing - A case study for a biomolecule
|1.35 p.m. - 2.15 p.m. Lunch Break
|2.20 p.m. - 4.35 p.m.
Session 4: Managing Post Approval Changes & (draft of) ICH Q12
|This session leads to discussion on the framework to be followed for post approval CMC changes & core expectations as per the draft ICH Q12 guideline.
|2.20 p.m. - 3.30 p.m.
Managing post approval changes & (draft of) ICH Q12 in Biologics
|3.30 p.m. - 3.45 p.m. Tea Break
|3.50 p.m. - 4.35 p.m.
Managing post approval changes & (draft of) ICH Q12 in Vaccines
|4.40 p.m. - 5.15 p.m. Panel Discussion
|5.15 p.m. - 5.45 p.m. Q & A - Felicitation
Friday March 24, 2017
Session Time and Title
|9.15 a.m. - 10.15 a.m.
Necessity for Right First Time - Metrics for the quality organization
|This session will explain the importance of indicators - Lag & Lead Indicators will form a framework for the quality organization
|10.15 a.m. - 10.30 a.m. Tea Break
|10.35 a.m. - 11.45 a.m.
Session 5: Practical Approach for Quality Risk Management
|This session will explore quality risk management steps and how to use various risk management tools
|10.35 a.m. - 11.10 a.m.
Practical Approaches for Quality Risk management in Vaccine manufacturing unit operation- A case study
|11.10 a.m. - 11.45 a.m.
Practical Approaches for Quality Risk management in monoclonal antibody manufacturing unit operation- A case study
|11.50 a.m. - 12.35 p.m.
Session 6 : Integrity of Operations for Quality Teams
|Operation integrity is the merging of People, Process & Assets into a well defined, highly efficient & proactive organization. Examples of failure will highlight the disadvantages of absence of these elements
|12.40 p.m. - 1.20 p.m.
|1.20 p.m. - 2.15 p.m. Lunch Break
|2.20 p.m. - 3.15 p.m.
Session 7: Approaches in Deviation management & Investigations in manufacturing lines
|This session highlights deviation management techniques for investigation in manufacturing
|3.20 p.m. - 3.40 p.m.
|3.45 p.m. - 4.00 p.m. Tea Break
|4.00 p.m. - 4.30 p.m.
Session 8: Challenges in cold chain distribution
|This session highlights challenges that biologics & vaccines manufacturers face while
managing the cold chain
|4.30 p.m. - 5.30 p.m. Q & A - Felicitation
Dr. Akshay Goel, Sr VP- Technical Development; Biological E. Ltd, India
Dr. Goel's career encompasses R&D, technology transfer, process development, process scaleup, process validation, clinical manufacturing, commercial manufacturing and regulatory approval of several
vaccine candidates in both US and India. Prior to joining the Biological E, Dr. Goel was the Chief Scientific Officer (CSO) at MSD Wellcome Trust Hilleman Labs in Delhi . Dr Goel was instrumental in building
the company's scientific portfolio, with a focus on developing affordable vaccines for the developing world. Dr. Goel served as Director, new vaccines, Serum Institute of India. He had a leadership role in
the development and launch of the Meningococcal A conjugate vaccine (MenAfriVac).His portfolio at SIIL also included technology transfer, process development, process validation, clinical and commercial
manufacturing, NRA registration and WHO prequalification of a Hib conjugate vaccine. Dr. Goel was interviewed for a feature article in GAVI Alliance progress report titled "India,Expanding the
world's vaccine production". Before returning to India in 2005, Dr. Goel worked at Baxter and Pfizer in US. As a part of Pfizer Global Manufacturing in Kalamazoo MI, he successfully led the legacy process
revalidation effort of approximately fifty products, which was the root cause of a US-FDA warning letter. As a part of the Baxter BioScience Vaccines Strategic Business Unit at Beltsville, MD, Dr. Goel was
involved with the rapid development and launch of a Meningococcal C conjugate Vaccine. He received Baxter's distinguished corporate technical award in 2001 for the project titled "A novel conjugate
vaccine against meningococcal C meningitis".Dr. Goel graduated with a B.Tech in Chemical Engineering from Indian Institute of Technology Kanpur. He completed his PhD in Biochemical Engineering from
University of Pittsburgh and did a post-doctoral assignment at University of Maryland, Baltimore. He has over 30 publications.
Dr.Dhananjay B. Patankar, Vice President - Pharmaceutical & Biopharmaceutical Development, Syngene International Ltd, India
Dr. Patankar is Vice President–Pharmaceutical and Biopharmaceutical Development at Syngene International Ltd. Dr. Patankar heads the Biologics business unit, in
addition to other business units dealing with formulations and analytical and stability services. He has over 20 experience in the biopharmaceutical industry and in this tenure, he led the development and manufacturing of seven biosimilar products which are currently sold in the Indian and other markets, as well as the first Indian
biosimilar product approved and currently sold in Europe. At Syngene, he has led a contract R&D and manufacturing group that developed and supplied 8 novel biologics
which have entered human clinical trials. He has established and led manufacturing facilities to obtain European Union GMP certification in his current and previous
organizations. Prior to Syngene, he was Chief Operating Officer at Intas Biopharmaceuticals and Senior Scientist at Wockhardt. Dr. Patankar has also served on a national task force for the establishment of regulatory pathways for recombinant products in India in 2004. He served with USP (US Pharmacopeia) as Chair of the Medicines Compendium–Biologics Expert Committee and currently is a member of the BIO2 Expert Committee on Proteins.Dr. Patankar is a Chemical Engineer and did his Ph.D. at the University of Utah, followed by post-doctoral research at Rutgers University.
Dr. Gopi Vudathala, Executive Director & Head - Quality, GSK Vaccines
Dr. Vudathala is Executive Director and Head of Quality Advocacy at GSK Vaccines. He was previously Head of Global Regulatory Affairs CMC, Compliance at GSK Vaccines (former Novartis Vaccines), where
he provided regulatory CMC, Compliance strategy and support for the global approval and commercialization of Vaccines to prevent various diseases. Dr. Vudathala has had extensive experience in
regulatory and quality policy. He was Vice-Chair of the Technical Development and Operations Committee, Pharmaceutical Research and Manufacturers of America, influencing the industry and Agency
thinking on key Quality challenges and current issues pertaining to pharmaceutical drugs, e.g., drug shortages, track and trace, anti-counterfeiting measures, quality-by- design and quality risk
management. He has contributed to the development of several ICH guidelines. He has led many symposia and workshops on key current topics of interest. He is the founder of XCell Pharma Consulting,
was Associate Vice President at Sanofi and Senior Manager at P&G Pharmaceuticals as well as Health Canada and has considerable experience in the regulatory and quality aspects for small molecules,
biologics, drug-device combinations and vaccines. He gained his Bachelor's degree in Pharmacy from Bangalore University and his Ph.D. in Pharmaceutics and Drug Design from the University of Alberta.
Dr. Himanshu Gadgil, Chief Scientific Officer & Operational Head- Enzene Biosciences, India
Dr. Gadgil is the Chief Scientific Officer and Operational head at Enzene biosciences, a subsidiary of Alkem Laboratories. Prior to this Dr. Gadgil was with Intas Pharmaceutical Biosciences division, Under his leadership the company launched 6 biosimilar products in India and 1 Biosimilar product in EU. He has worked for over 10 years in leadership positions in esteemed companies in the US such as Amgen Inc. and Waters /Micromass Corporation. Dr.Gadgil is accomplished leader in biopharmaceutical process and analytical development with several years of experience from pre-IND to post commercialization of therapeutic proteins with In-depth knowledge of the up-stream and down-stream unit operations and process parameters for the production of the mAb platform. Dr. Gadgil has broad expertise in Discovery Research, Process development, Formulation Development, Manufacturing and Quality with over 40 publications and patents. Dr. Gadgil has pursued PhD in Biochemistry from
University of Tennessee, Memphis, USA.
Dr. Rajesh Kumar, Deputy General Manager– Regulatory Affairs, Gennova Biopharmaceuticals Ltd, India
Dr. Rajesh Kumar Singh is Deputy General Manager at the Gennova Biopharmaceuticals Ltd., Pune, India, a leading biotechnology company. He started his career as a fermentation technologist at the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, India and then went to complete his PhD at the European Molecular Biology Laboratory (EMBL), DESY Hamburg, Germany. At EMBL, as a part of TB Structural Genomics Consortium, he worked towards solving structure of targeted proteins by using X-ray crystallography methods. After two years of Post Doc at the Institute of Biochemistry, University of Greifswald, Germany, he joined the
National Chemical Laboratory (CSIR), Pune, India. All his works were published in the peered reviewed journals of international repute. He has been with Gennova since
2011 and is responsible for Regulatory Affairs and the upstream process development of biotherapeutics and vaccine development program in close collaboration with
both national and international academic and industrial partners, especially for malaria, HPV, leishmaniasis and tuberculosis.
Ravi B Menon, Additional Director - Production, Serum Institute Of India Pvt Ltd, India
Ravi B Menon is the additional director of Production at Serum Institute Of India Pvt Ltd, he is heading the production system capable of delivering 120 million vials of Vaccine per annum (MMR, Influenza,
OPV, IPV, Polysaccharide Conjugate group vaccines, Vero Rabies, Rotavirus Vaccines and Rabies Monoclonal antibodies), he is also part of the team developing, Polyvalent Meningitis, Dengue and
Pneumococcal vaccines at SIIL. He was also responsible for setting up three fill and finish lines for Esvee Pharmaceuticals as a works manager. As part of Hindustan Antibiotics Ltd, he was responsible for
LVP manufacturing facility of capacity 12 million bottles per annum operating at greater than 95% capacity utilization. The product mix included Plasma Volume Expander in addition to conventional IV
Fluids. Over the span of more than two decades he has faced multiple successful audits . He also worked with Ranbaxy and during his tenure in the company he was In-charge of the Aseptic subdivision
operations of an Ampoule line. Ravi Menon has masters in Pharmacy from Birla Institute of Technology and science, Pillani and Masters in Management Studies (Systems) from Symbiosis Institute of
Dr. Reinhard Glueck, Chief Scientific Officer, Zydus Cadila, India
Dr. Reinhard Glueck is the Chief Scientific Officer at Zydus Cadila Healthcare, Amedabad. He is chairing the Zydus research center, Etna Biotech, Catania, Italy, too. Previously he held the same position at
former Berna Biotech, today Crucell. He is an expert in innovative vaccine development. He has first in history developed the so called Immunostimulatoary reconstituted influenza virosome or virosome
technology which is today applied in millions of influenza and hepatitis A vaccines worldwide. He also introduced new adjuvants such as non-toxic HLT for influenza vaccines which has obtained
marketing authorization in Switzerland in 2001. In his role of CSO at Zydus Cadila Healthcare Ltd, he has entered into collaboration with world class institutions (IDRI, Thelormedix, Statens Serum Institute Denmark, ICGEB, New Delhi and others) to evaluate new and better adjuvants. Reinhard Glueck was until recently the President of Swiss Biotech Association and has been awarded with the Honorary
Presidentialship of this organization. He is member of many scientific boards, worldwide. In his career he published more than 100 peer reviewed papers and holds more than 10 patents.
Capt. Ricky Bithar, CEO - Absolute Cold, India
Capt. Ricky Bithar is the CEO of Absolute Cold, and has over 15 years experience in providing a variety of cold chain solutions for physical movement of thermosensitive products requiring short-long term specific temperature windows for storage . Ricky started Absolute Cold In 2002 as a distribution arm of Absolute Cold GmbH, marketing and distributing cold chain shippers to the Indian pharmaceutical market . The organisation provides products and services to UAE, Bangladesh and Malaysia . The concept of reusable shippers was brought to the space of anti cancer vaccines by Ricky and his team, for the first time in the country.
Swapnil Ballal, Senior Director Quality Assurance Product Operations - Dr Reddy's Laboratory, India
Swapnil Ballal leads the Quality Assurance of Biologics Development and Operations at Dr. Reddy's Laboratories as Senior Director QA, Product Operations. Swapnil has over 21 years of experience in the biotechnology industry covering Development, Manufacturing and Quality Assurance of biopharmaceuticals. He majored in Marine Biotechnology, with Masters of Sciences from Goa University. With a vast experience in bio manufacturing operations he has played key role commercializing several key biosimilar products. His current roles and responsibilities include development of quality compliance systems and strategies for regulated biotechnology products. Prior to Dr. Reddy's, he has worked with Biocon, GE Healthcare, Intas Biopharmaceuticals and Wockhardt. He is an active member of ISPE, ASQ and PDA.