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
07:30 - 08:00
Registration & coffee
08:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
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 04.jpg

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.

Kristina Bindus Small.jpg

    Kristina Bindus has over 25 years of experience in QA, RA, Auditing and Pharmacovigilance within leading (bio)pharmaceutical and medical devices companies.
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

Date 1

Date 2

Date 3

Contact Quastion for more information about this Responsible Person for GDP training.
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

full

full

full

 
Other courses you might be interested in:

On demand

Good Distribution Practice

1 Day

On demand

GDP: Cold Chain Management

Half-day

On demand

Quality System Management in GDP

1 Day

Heading 6
You are signing up for:
Responsible Person for GDP

date

hhmm

- hhmm

Quastion Learning Center

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

Please fill in your info below
1. Company details
Company name *

Enter a company name

VAT-number *

Enter a valid VAT-number

Address *

Enter an address

City *

Enter a city

E-mail address *
ZIP code *

Enter a ZIP code

Country *

Enter a country

arrow&v

Enter a valid e-mail

2. Participants
Select the number of participants:

Alert number

Since we provide a lunch, please inform us of any food allergies or restrictions:
1
First name *

Enter a name

Last name *

Enter a name

Possible food allergies or restrictions
2
First name *

Enter a name

Last name *

Enter a name

Possible food allergies or restrictions
3
First name *

Enter a name

Last name *

Enter a name

Possible food allergies or restrictions
4
First name *

Enter a name

Last name *

Enter a name

Possible food allergies or restrictions
5
First name *

Enter a name

Last name *

Enter a name

Possible food allergies or restrictions
3. Discount Code
I have a discount code

Your code has been accepted!

Code is not valid has been used already

€ discount per participant is applied.

4. Price calculation
Price per participant
Number of participants
Total price
€ 899
(excl. VAT)
€ 899
discount applied
1
€ 899
€ 899
(excl. VAT)
If you use the KMO-portefeuille:
(Check if your company is qualified to use this)
arrow&v
€ 899
(excl. VAT)
incl. 5% promo discount
discount applied

Please check this box

* I accept the Terms of Use and the Privacy Policy.
I want to receive the newsletter.
4. Payment

€ 899

Total amount:

Choose your preferred payment method

You will receive a confirmation about your signup after the online payment is completed.

We will send you our account information so you can transfer the money when it suits you best.