Register a second person and receive 5% off of your total course-fee immediately!

Responsible Person for GDP

1 Day
GDP

This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and GDP requirements. You will learn about the role of the Responsible Person and his/her responsibilities according to GDP requirements.

Quastion LogoWhite.png
Audience

Anyone who is becoming or is in function as RP, Deputy or QP, or is involved in QA/RA. Anyone interested in Good Distribution Practice requirements

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

Program

Implementation of the New EU GDP Guideline

  • Well-known or new: a summary of the most important changes

GDP Compliance: How to Achieve It?

  • Roadmap: what do I need?

  • How to get started and to maintain a GDP-compliant status?

  • The counterfeit and pharma supply chain

Quality Management System

  • How to develop and implement an effective Quality Management System?

Roles and Responsibilities of the RP

  • Qualification requirements to the RP

  • Duties of the RP

  • How to keep it all under control?

  • What and how to delegate?

  • How to report and control delegated activities?

  • RP deputy: who can help me?

RP Quality Oversight: Principles & Practical Approach

  • RP Quality Oversight: what to oversee and how to proceed?

  • How to establish a Quality Oversight process

Batch Release for Sale: Requirements & Reality

  • Batch release for sale: is this mandatory?

  • Batch release for sale: to do or not to do?

  • What does Final Batch Release mean for RP?

  • RP vs. QP role in Final Batch Release

  • Where your responsibility as RP GDP stops

  • How to identify what to verify and control?

Returns: Time- & Risk–reducing Approach

  • What are the requirements and how to implement?

  • Time- & risk-reducing approach

GDP(/GMP) Inspections

  • GDP inspection readiness

  • Frequent findings

  • Expectations with regards to the RP

Temperature-controlled Distribution

  • Get to know your distribution chain

  • How to identify the weakest links and what to do?

  • How to manage cold chain products: warehousing & transport

  • How to manage 15-25°C products: warehousing & transport

  • Temperature monitoring or control? – what is the best option for the product

How to Manage Outsourced GDP Activities & GDP Audits

  • What is a GDP activity?

  • How to qualify & manage GDP outsourced activities?

  • Approach a GDP Audit

  • Reporting deficiencies : CAPA’s or risk mitigation plan?

  • Quality Agreements requirements & inspectorate expectations

Transport: a Grey-zone or Well-known Activity

  • How to manage GDP-transport?

  • Risk-based approach and where to pay attention to

Management Review & Monitoring in Practice

  • How to identify the parameters for monitoring

  • The Best Industry Practices for Management Review and Monitoring

Participants about this course:

"This RP GDP training met my professional education needs."

Karlien Velghe

"This course was well-organized and easy to follow."

Regulatory Affairs & Pharmacovigilance Manager at Daiichi Sankyo Belgium

"Participation and interaction during this course were strongly encouraged."

Medical Team Leader at a consultancy company

"The topics discussed during this course were relevant for me. The educational materials distributed were helpful."

Jo-An Rigo, Regulatory Affairs Officer at Menarini Belgium

Date

13 February 2020

Not available on this date?
You can always contact us for a course on demand
Do you prefer to send an offline signup form via mail?
Download it
 
Other courses you might be interested in:
Good Distribution Practice

1 Day

Responsible Person for GDP: Refresher

1 Day

GDP: Cold Chain Management

Half-day

Heading 6

+32 (0) 2 899 05 68

Email Icon.png
KF location icon.png

Leuvensesteenweg 643 bus 7

1930 Zaventem

Belgium

LinkedIn Icon.png
Quastion Logo white.png

a division of

Qplus consult BVBA