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Responsible Person for GDP: Refresher

1 Day
GDP

This training is a supplement to our successful RP for GDP course. Learn GDP news and importance of risk management within a GDP quality system. Learn more on management of distribution and transport.

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Audience

Anyone who followed a RP training in the past and needs to update his or her knowledge

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
Price
€ 899

per participant    (excl. VAT)

✓ Exclusive learning approach

✓ Personal course documentation

Lunch, water, coffee & tea

Networking

✓ Course certificate after completion

Location

Quastion Learning Center (Qplus consult BVBA)

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

Your Trainer

Kristina Bindus

  • Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.

  • Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.

  • Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.

  • Kristina is specialized in online medical communication: webcast, webinar and e-learning.

  • She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.

  • Kristina has an extensive experience in Quality & Pharmacovigilance.

Program

Management of Authorized Activities

  • Which activities (purchase, storage, supply, export)

  • Type of products (cold chain, psychotropics, ...)

  • Supply chain of products (physical + financial flow): from manufacturer to customer

  • Samples

Quality Management System

  • Activities, processes, responsibilities

  • Structure

  • GDP risk assessment

Complaint Handling

  • Quality vs distribution

  • RP oversight

  • Timelines + link with recall and PV

  • Interaction with supplier, warehouse, transporter

Returns

  • Risk based approach

  • Visual check

  • Document check

  • Declaration storage conditions

Participants about this course:
Contact Quastion for more information about this Responsible Person for GDP: Refresher training.
 
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Heading 6

+32 (0) 2 899 05 68

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Leuvensesteenweg 643 bus 7

1930 Zaventem

Belgium

TAV: BE 0822 940 179

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a division of

Qplus consult BV

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