PDA Training and Research Institute (TRI)
Courses in Israel

2009 budget restrictions? Ban on international travel to conferences and courses?

PDA’s Israel Chapter is proud to announce expert-led PDA TRI courses coming to you HERE IN ISRAEL, with top PDA faculty on two of the regulators’ hottest topics impacting pharmaceutical and biopharmaceutical operations: Quality Risk Management and Process Validation.

This is a unique opportunity, not to be missed, to expand and strengthen your skills to make a positive impact on your organization. Registration is on a strictly first come / first served basis, so mark your calendars now and register early to avoid disappointment – since there are workshops the number of participants is limited.

Register for two courses and save money – see below for details

Courses will be presented in English

Venue: Lev HaKongressim, Weizmann Science Park, Ness Ziona, Israel
(Lev HaKongressim is conveniently located in the center of the country and provides free parking on site as well as being in walking distance of Rehovot Train Station)
for map please click here

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Duration: 2 - Day Course
Date: 8-9 July 2009
Location:Lev HaKongressim, Weizmann Science Park, Rehovot, Israel
PDA # 515

Process Validation and Product Lifecycle
In November 2008, FDA issued a revised, draft guidance on process validation. The draft document contains recommendations which are substantially different from those in the 1987 Process Validation Guide. This two day course will review the draft guidance in-depth, use case studies to demonstrate approaches to implementation and discuss how existing (legacy) facility, equipment and products, where qualification / validation was performed five, 10 and in many cases 20 years ago, can be brought into compliance with the expectations for ongoing verification.

  Day One – July 8, 2009
Overview and Process Design (Stage One)

08:00 – 09:00	Registration and Coffee
09:00 12:30	Session 1 : Process Validation: the 2008 Draft
	Welcome and Introduction Introduction to the Lifecycle approach to validation Regulatory Basis and Expectations Current Industry Trends and Practices 1987 FDA Guidance and EU Annex 15 Review and Critique of Draft guidance PDA comments on draft guidance Stage One: Process Design and Use of DOE
13:30 – 16:30	Session 2 : Stage One: Process Design continued Case Study / Workshop
	Participants will work on a theoretical case study in small groups, to develop a process validation protocol using data provided and guided by course faculty. The workshop will enable participants to assess process development data and identify process variables through understanding of the Product Control Strategy. The data will be tied in with the Target Product Profile, Critical Quality Attributes, Critical and Key Production Parameters. Outcomes will be reviewed with the entire class and tied in with the concept of a lifecycle approach to validation and Quality by Design.

  Day Two – July 9, 2009
Process Qualification and Continued Process Verification

09:00 12:30	Session 1
	Stage Two: Process Qualification Facility and Equipment Revisited Stage Three: Continued Process Verification Legacy (existing, validated) products and the new paradigm Use of statistics in Process Validation
13:30 – 16:30	Session 2 : Workshop and Q&A
	Performance Qualification and ongoing verification Workshop on prospective validation using a case study to show how to bring an existing process into conformance with the revised guide Concluding Question and Answer panel and faculty guided discussion to wrap up the course. Suggestions from participants and faculty as to how they believe industry can make the guidance work in the current economic climate without placing additional / unreasonable financial burden on industry Course Wrap-up and Conclusions

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About the Course Director:
Hal Baseman
Hal Baseman is Chief Operating Officer and a Principal at ValSource LLC, a large validation consulting and service firm. With over 30 years of experience in pharmaceutical operations, validation and regulatory compliance it would be hard to find a better qualified person to direct this course. Hal has held positions in executive management and technical operations at several drug manufacturing and consulting firms. A member of the PDA Board of Directors, Co-Chair of the PDA Science Advisory Board, Co-Leader of the PDA Validation Interest Group, Co-Chair of the PDA Risk Management Task Force responsible for writing PDA’s Technical Report on Quality Risk Management of Aseptic Processes, Hal’s contributions to PDA are too numerous to list in a brief biography.
A long time faculty member of PDA’s Training Research Institute Hal was awarded the 2009 James P. Agalloco Award for Excellence in Education in appreciation of the enthusiastic feedback received from his course participants over the years. He holds an MBA in Management from LaSalle University and a B.Sc. in Biology from Ursinus College.
Hal co-chaired the preparation of PDA’s comments to FDA on their draft Process Validation guidance, so rest assured that he is familiar with the smallest nuances of this document.

Additional Course Faculty:

Raphy Bar
Raphy Bar is a consultant to the Pharma, bio-Pharmaceutical and medical device industries, at BR Consulting that provides development and analytical support to investigational, generic, new and combination drug products. He has served as Director of Analytical Department at Pharmos and prior to that managed the Analytical R&D Laboratory at Teva. With a doctorate in Chemistry, Raphy is highly knowledgeable in analytical and bioanalytical method development, validation, stability studies, and in particular statistical analysis of data and applications such as Design of Experiments.
Raphy is a member of PDA’s Scientific Advisory Board and President of the Israel Chapter of PDA.

Robert L. Dana
Bob Dana is Senior Vice President, Regulatory Affairs and Training and Research Institute for PDA. Associated with the pharmaceutical industry for more than 40 years, Bob has a wealth of compliance, Quality Assurance and Regulatory experience. Bob regularly presents on Quality and Compliance issues at international conferences, and is a lecturer at both the PDA TRI and the University of Tennessee’s Continuing Education course on aseptic processing.

Karen Ginsbury
Karen Ginsbury is President of PCI Pharmaceutical Consulting a company that provides QA and GMP compliance services to the pharmaceutical and allied industries. A UK qualified pharmacist with an MSc. in Microbiology, Karen has conducted numerous workshops on Quality Risk Management as well as helping companies to perform risk assessments in-house. Karen is a past-President of PDA’s Israel Chapter, a member of PDA’s Regulatory Affairs and Quality Committee and is currently co-editing a Technical Report on GMPs for Investigational Drug Products 

Participation Fees (for one course): PDA member: US$ 800 Non-member: US$ 1050 (includes PDA membership for one year) Discount for participation in two courses: (Quality Risk Management and Process Validation ) PDA member: US$ 1450 Non-member: US$ 1700 (includes PDA membership for one year) Discount for registration of five persons at one time: Pay for four instead of five i.e. fifth participant free

Registration Form        PDF Format For additional information about the PDA Training and Research Institute, see www.pdatraining.org