TWO DAY-COURSE

Good Controlled Temperature, Packaging, Transportation, and Storage Practices

Tuesday 21 & Wednesday 22 December 2010

Lev Hakongressim, Weizmann Science Park, Ness Ziona

2010 budget restrictions?
Ban on international travel to conferences and courses still in place?

PDA’s Israel Chapter is proud to announce a two-day PDA Europe course coming to you HERE IN ISRAEL, with PDA’s expert faculty on one of the regulators’ hottest topics impacting pharmaceutical and biopharmaceutical operations: Good Distribution, Transportation, Shipping and Storage Practices.

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 register early to avoid disappointment – since there are workshops the number of participants is limited.

Regulators are paying closer and closer attention to how your company distributes and transports product to ensure fitness for use at the user and to mitigate risks associated with the potential for interference or substitution of your carefully manufactured products with counterfeit and /or substandard product. This course, directed by one of the world’s leaders in the field, Rafik Bishara is a chance to understand what the regulators are looking for and how you can secure your supply chain to provide the patient with what they need and what they deserve to get – safe and effective medication.

Day One – December 21, 2010
08:00 – 09:00	Registration and Coffee
09:00 - 12:30	Session 1: Overview of Current Regulations and Guidance
Introduction and Course overview Global governance & oversight USP <1079> introduction Industry consensus practices & guidelines e.g. PDA Technical Report No. 39 Activities of PDA’s interest group for cold chain – PCCIG
13:30 – 16:30	Session 2: Practical Applications and Case Study
Thermal Test Exercise Technical Report No. 46, The Last Mile IATA regulations for air transport – Chapter 17 & Label Introduction to thermal packaging material

 

Day Two – December 22, 2010
08:00 – 09:00	Networking and Morning Coffee
09:00 - 12:30	Session 1: Container Qualification Practices
Review of Day one Qualifying a Container: Design Challenging Testing Documentation Understanding the package handling environment Designing realistic (& supportable) ambient test protocols Best practices for thermal package testing (thermal and dynamic)
13:30 – 16:30	Session 2 : Practical Applications and Case Study
Case study: handling temperature deviations and excursions from trip monitoring exercises PQ considerations – some factors to consider in trip monitoring Use of Risk Management tools in GDP Q&A and course close-out

Target Audience:

QA, Compliance, supply chain, operations, validations, responsible pharmacists, packaging.

Course Director:

Rafik Bishara
Rafik Bishara is Chair of the Pharmaceutical Cold Chain Interest Group, USA Branch and was one of the driving forces behind the PDA Technical Report #39, “The Last Mile, Guidance for Good Distribution Practice” and is internationally acclaimed for his vast store of knowledge regarding every aspect of this increasingly complex topic.

Dr Bishara worked for Eli Lilly & Company for 35 years and served as Director of Quality Knowledge Management and Technical Support. He was part of the USP working committee developing the General Chapter <1079>, Good Storage and Shipping Practice and is a Pharmacist by profession. Today Rafik provides consultancy services and is acclaimed as one of the leading experts in the field of pharmaceutical distribution controls.

Additional Course Faculty:
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 helped companies design and implement Quality Systems suitable for ensuring international GDP requirements, regulations and expectations are met. Karen is a past-President of PDA’s Israel Chapter and a member of PDA’s Regulatory Affairs and Quality Committee.

 Participation Fee:
PDA member: 3200 NIS
Non-member: 4200 NIS
(includes PDA membership for one year)

For registration form please click here

 Discount for registration of five persons at one time:
Pay for four instead of five i.e. fifth participant free.
For more information about PDA Europe, see www.pda.org.  enter “European Events”

 

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Organized & 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
E-mail: bioforum@bioforum.co.il
site: www.bioforum.co.il