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SMi proudly presents this half-day interactive workshop at the 2nd annual Lyophilization US conference, Lyophilization - Development through Tech Transfer!

This half-day workshop will aim to provide practical experience for delegates on meeting QbD requirements and other CMC challenges encountered in the development of lyophilized dosage forms. The impact o lyophilization as a pharmaceutical unit operation is expected to grow as the biopharmaceutical market continues to expand. Hence, a well-defined development and tech transfer plan based on QbD principles will mitigate downstream risks and ensure smooth scale-up, approval and launch of lyophilized products.

The workshop will enable you to:

- Understand CMC requirements for lyophilization

- Incorporate QbD into everyday practice

- Define your tech transfer plan for lyophilization process

- Mitigate risk in compliance and downstream bioprocessing

VPs, Directors, Heads, Chiefs, Principals and Managers of:

  • Scientist
  • Bioprocessing
  • Formulation
  • Manufacturing
  • Tech Transfer
  • R&D

from pharmaceutical, biotech and CMOs

Workshop LEADER

keynote-img

Ralph Tarantino

Pharmaceutical Consultant & Principal, Steritech Solutions, LLC

Dr. Tarantino is a Subject Matter Expert in the formulation of injectable dosage forms, with over 25 years’ experience in the pharmaceutical industry. He was instrumental in the development of numerous marketed drug products. His experience ranges from bench level scientist to senior manager at Hoffmann-La Roche Inc. where he was the Director of Sterile Product Formulation and Clinical Manufacturing for 17 years.
Dr. Tarantino specializes in peptide/protein formulations, drug delivery systems and the solubilization of new molecular entities. He has trained FDA reviewers on the topic of peptide/protein formulation and mentored numerous undergraduate and graduate scientists in the development and manufacture of sterile products.

Currently he serves as consultant to pharmaceutical, investment and legal firms. His projects have included evaluation of drug delivery technologies, expert testimony in formulation related cases and criticality analyses of drug product formulation and manufacture.

Highlights of Dr. Tarantino's career include:

Leadership role in development of 9 marketed products and Sterile Product Subject Matter Expert for Sterile products at Roche Nutley
Global Peptide Delivery Champion. Head of Sterile Clinical Manufacturing with 7 successful Pre-Approval Inspections
Extensive FDA interactions and FDA trainer for Biopharmaceutical Formulation and Stability
Leader in international harmonization and Chair International Formulation technology Working Group for Sterile Products
Invited Lecturer, American Association of Pharmaceutical Scientists Eastern Regional Meeting, “Technology Transfer for Sterile Dosage Forms”
Adjunct Assistant Professor in Pharmaceutical Sciences, Long Island University
Elected Chair, Basic Pharmaceutical Sciences, Academy of Research and Science, Basic Pharmaceutical Sciences Representative, Education Standing Committee, American Pharmaceutical Association
 

Workshop programme

8:30 Registration & Coffee

9:00 Workshop Leader's Opening Remarks

Ralph Tarantino

Ralph Tarantino, Pharmaceutical Consultant & Principal, Steritech Solutions, LLC
View Bio

9:10 Developing a Thorough Development Plan to Meet CMC Requirements

9:40 Roundtable Discussion - Criticality Analysis for Lyophilization

10:10 Roundtable Discussion

10:30 Morning Coffee

11:00 Lyophilization: Tech Transfer and Scale-Up

11:40 Roundtable Discussion

12:00 Q&A

12:30 Closing Remarks from Workshop Leader and End of Workshop

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Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830
USA

Renaissance Woodbridge Hotel

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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