PDA Training and Research Institute (TRI)
Courses in Israel

July 6 – 9, 2009

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

Duration: 2 - Day Course
Date: 6-7 July 2009
Lev HaKongressim, Weizmann Science Park, Rehovot, Israel

PDA # 514

ICH Q10 Pharmaceutical Quality System guidance was finalized in June 2008. ICH Q9 on Quality Risk Management has been incorporated into the EU GMPs as Annex 20. Chapter 1 of the EU GMPs has been updated to make the use of Quality Risk Management mandatory. However, the ICH guidances, including Annex 20 / Q9 are voluntary guidances. Most of industry is in the learning stage and encountering all sorts of problems regarding the level and method of implementation of these guidances. This course will use a combination of lectures and workshops to provide participants with practical information as to how to implement Quality Risk Management in a cost-effective and beneficial manner.

  Day One – July 6, 2009
Overview and Update on Risk Management

08:00 – 09:00 Registration and Coffee
09:00 12:30 Session 1 : Relationship of Process to Risk
  • Welcome and Introduction
  • Regulatory Basis and Expectations
  • Current Industry Trends and Practices
  • Quality Risk Management – ICH Q9
  • Risk Management Techniques: Tools and Methods
  • Aseptic Processing
    • PDA Tech Report 44 Overview and Survey
13:30 – 16:30 Session 2 : Case Study / Workshop
  Participants will work in small groups facilitated by the course faculty to perform a risk assessment using the FMEA tool for a theoretical case study in aseptic processing.
Groups will share their outcome with the entire class and faculty will critique the work so that participants will be able to take home a sample risk assessment as a template for use in their company.

  Day Two – July 7, 2009
Practical Applications of Risk Management

09:00 12:30 Session 1
  • Risk Management in Product Development
    • Using risk management to develop a product control strategy
    • When to start the risk assessment
    • Ongoing revision and update of risks
      (feedback from the development process)
  • Risk Management in Process Design
    • Using risk management tools to analyze and improve your process
  • Risk Management in Process Validation
    • How to focus on what really matters
13:30 – 16:30 Session 2
  Participants will split into small groups to work on theoretical risk management scenarios. One set will develop a proactive risk assessment for a process / product. The second group will work on using risk management in investigating and correcting a process failure. Course faculty will guide the groups into constructive conclusions and present the case studies as take home tools for the entire class.

Duration: 2 - Day Course
Date: 8-9 July 2009
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

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 (Process Validation Course)
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


Produced by
Bioforum Applied Knowledge Center

Bioforum - Applied Knowledge Center
Lev Hakongressim, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
site: www.bioforum.org.il


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