ISPE India Affiliate News

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Current Trends and Developments in Sterile Manufacturing Technology
Westin Hotel, Mumbai, India
21 - 22 April 2017

Name of Presenter: Richard Chai
Technical Service Manager
STERIS Corporation
As a Technical Service Manager with STERIS Corporation based in Singapore, Richard has been providing technical training to customers in topics related to cleaning and bioburden control for cleanrooms, including disinfectant validation, as well as cleaning and cleaning validation for product contact surfaces. He is also an industry speaker at ISPE events. Prior to joining STERIS, Richard had 13 years of manufacturing and validation experience working in dry powder inhaler plant, biotech sterile fill and finish plant, and medical device and biopharmaceutical facilities. He has in-depth understanding of the requirements of cleaning and disinfection in cleanrooms, as well as best practices in bioburden control. Richard has also worked 3 years as a validation consultant providing validation support to various pharmaceutical customers in the area of equipment validation, cleaning validation for product contact surfaces, disinfectant validation, as well as cleaning procedures for both product and non-product contact surfaces.

Title of Presentation 1:  Challenges in Stainless Steel Maintenance ( 3 MB)
Title of Presentation 2:  Current global industry best practices in clean room bioburden control, cleaning and disinfection ( 7 MB) 

Name of Presenter: Michelle Frisch
Sr. Manager Global Technical Systems
Michelle Frisch holds two Bachelor of Science degrees, and also maintains a Technical Education Teaching Certificate. She has completed her Masters in Business Administration. She is a member of the prestigious “Golden Key National Honor Society”. She has presented at numerous ISPE Conferences and International Symposiums worldwide and was the first American speaker to present at an International Pharmaceutical Symposium in Japan.
Michelle worked for Boise State University as a program manager, in conjunction with OHSA, establishing/developing OSHA compliance and writing operational/training manuals for external corporations. Along with this she developed risk assessment training for blood born pathogens and high-risk environmental exposure. Her articles have been published in Pharmaceutical Technology, Manufacturing Chemist, just to name a few.
Michelle has been working with the pharmaceutical industry for over 20 years, specializing in high containment technologies. She is a member of the American Institute of Chemical Engineers, American Industrial Hygiene Association, AAPS, SBE, ISPE, and is on the Standards Committee for the American Glovebox Society. Michelle has also served on the subcommittee for COP for ISPE. 

Title of Presentation: Sterile Microsphere formulations ( 1 MB)

Name of Presenter: Dirk Steinhäuser
Vice Head of Glatt GIT Dresden Engineering office
Dirk Steinhäuser has more than 24 years professional experience in pharmaceutical projects and biotechnology. He holds a scientific degree in Process Biotechnology from University of Teesside, Middlesbrough, UK and an Engineering Diploma degree from Technical University Dresden, Germany.
He has worked for Engineering companies, equipment specialists, in R&D and in pharmaceutical companies (NEBC, Oxyphen AG, Linde AG and Glatt Group). He currently holds the position of the Vice Manager of Glatt GIT Dresden Engineering office, where he is steering Conceptual Design and Front End Engineering for biopharmaceutical projects as well being active in BD / Sales and Contract Management. He was part of the core team of the large scale Biotech project for Monoclonal Antibodies for Hoffmann-La Roche in Basel Switzerland, for which he had lived 2 years in Basel Switzerland. 
Dirk continuously engages in pharmaceutical education and training and has actively supported ISPE Europe, ACHEMA, Dechema GVC, Pharma+Food (EU), The American Academy of continuing Medical Education, and The Russian Pharma Association with specific contributions on congresses, publications and presentations during the past 20 years.


Name of Presenter: Anil Relan
Director, Life Sciences, Jacobs
Anil Relan, a member of ISPE & PDA, is currently working with Jacobs Engineering as Director Life Sciences for India and Asia. Jacobs is one of largest Professional Services Provider for the Life Sciences Industry globally. With more than 30 years of industry experience in Bio API & Dosage forms, Anil has been associated with Design, Delivery & debottlenecking of number of Sterile Fill & Finish Facilities for companies like Shantha (Sanofi), GSK, Biocon, Akorn, Serum Institute, Reliance Life Sciences to name a few.

Title of Presentation: Design of Sterile Fill & Finish Facility with Isolator Technology ( 3 MB)

Name of Presenter : Robert L Roy
SME Aseptic Filling & Validation, IPS
Roy offers more than 30 years of dedicated professional experience in aseptic products manufacture and advanced processing technologies. Over the past 10+ years he has been extensively involved in the engineering, operations and qualification of a number of isolator systems, and is currently considered to be one of the leading experts in the field. Other areas of expertise include potent material handling and containment, Single Use Disposable technologies, Blow Fill Seal technology, cleaning validation and CIP/SIP systems.
He has served in senior level management roles directing global engineering, design and manufacturing teams on fast-track design/build/qualification activities for clinical and commercial scale aseptic fill/finish facilities. Because of this background, he is uniquely qualified to assist clients in the development of business and operating plans for new projects.
He is currently serving on the ISPE committee to re-write the ISPE Baseline® Guide for Sterile Product Manufacturing Facilities, and frequently presents an FDA training module on isolators and RABS for FDA field inspectors and auditors.

Title of Presentation : Comparison of Barrier Isolators and RABS ( 2 MB)

Name of Presenter: Prasanna Vudayagiri
Director Automation, NNE
Prasanna Vudayagiri is an automation engineer and project manager . He has over 18 years ‘experience in the pharmaceutical and biotechnology industries specifically in the areas of control system and computer system validation. His greatest technical strength is in Process Automation Systems Design where he has amassed considerable experience in a wide range of control systems involving DCS, PLC, SCADA, and BAS applications used in Pharmaceutical and Biotechnology environments. He has extensive experience in computer validation ranging from setting up site procedures, co-coordinating validation and 21CFR Part11 projects, performing validation determination, validation planning, supplier audits, testing, and validation reporting through to compliance assessment. He has excellent knowledge on DCS, Batch control (S88), GAMP, cGMP, and MS Windows compliance solutions. Prasanna has lead teams on projects including initial design through to final process of commissioning and qualification. He has been responsible to establishing new business units demonstrating his abilities to coach, guide and mentor other Engineers.

Title of Presentation: Managing Requirements in Process Automation Design ( 4 MB)

Name of the Presenter : Lars Olsen
Global Technology Partner, NNE
Lars is a Global Technology Partner with more than 25 years of experience from Pharmaceutical Assembly and Packaging. Over the last 10 years, he has been working dedicated with Serialization and Anti-counterfeit protection as Subject Matter Expert within numerous global pharmaceutical companies. Covering roles from initiating Strategy and Impact Assessments through Scoping and Support with Regulatory Compliance and Packaging Technology/Supply Chain knowledge.

Title of Presentation: Serialization: Global Overview and Trends, Opportunities and Challenges ( 2 MB)

ISPE India Hyderabad Chapter Workshop on Pharmaceutical Packaging
3 - 4 May 2013
ISPE India Hyderabad chapter conducted a two-day work shop from 3–4 May 2013 in Katriya hotel Hyderabad. Themed “Recent Changes and Regulatory Compliances”, the workshop covered topics on recent changes in pharmaceutical packaging, regulatory compliances and Track & Trace systems.

The programme was well attended by industry representatives, vendors and regulators. The workshop was highly interactive with panel discussions and an enriching presentation on regulatory perception of recent changes in packaging requirements especially regarding track & trace for exports. Dr Appaji, Director General of PHARMEXCIL shared the government’s view on the implementation targets. He further suggested that being a neutral platform, ISPE can consider taking lead in bringing all the stake holders together to find solutions acceptable to both the regulators and the industry. The industry speakers also highlighted the concerns of the industry on the implementation time frames. The vendors presented various technologies available for implementation of the systems.
ISPE India Hyderabad Chapter would like to express great appreciation to all participants from the industry, vendors and exhibitors for contributing to the success of the workshop.

For pictures of the event, please click here ( 109 KB).

Stay Connected - India Affiliate eNewsletter 2012

Issue 1 - Click Here

Issue 2 - Click Here ( 680 KB)

Young Pharmaceutical Professional Educational Program
21 Jan 2012
ISPE India Affiliate presents a Young Pharmaceutical Professional Education Program on the topic 'Getting Ready for New Changes in Pharma Operations' at WelcomHotel, Vadodara, Gujarat. 
Click here ( 181 KB) for more information.

Training on Current Strategies for Pharmaceutical Validation
4 - 6 Mar 2011

The ISPE India Affiliate organised a 2-day training on Current Strategies for Pharmaceutical Validation at Hotel Dolphin Resorts, Vizag, A.P, India.
Click here ( 60 KB) for more information.

Young Pharmaceutical Professional Educational Program
26 Feb 2011

ISPE India Affiliate held a Young Pharmaceutical Professional Education Program (YPEP) on 26 February 2011 at Hotel Best Western Royal Park, Baddi, HP, India.
Click here ( 665 KB) for more information.





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