Register a second person and receive 5% off of your total course-fee immediately!
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 (RP) and his/her responsibilities according to GDP requirements.
This course contains new insights and ascpects of the role of the RP and includes new workshops.
Audience
Anyone who is becoming or is in function as Responsible Person GDP (RP) or Deputy 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)
10:00 - 10:30
Networking & closing
Price
€ 1200
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.
- 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:
Heading 6
Date
08 June 2023
Date 2
Date 3
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
You are signing up for:
Responsible Person for GDP 2023
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
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:
First name *
Enter a name
1
Last name *
Enter a name
Possible food allergies or restrictions
First name *
Enter a name
2
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
First name *
Enter a name
4
Last name *
Enter a name
Possible food allergies or restrictions
First name *
Enter a name
5
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.
Please check this box
* I accept the Terms of Use and the Privacy Policy.
I want to receive the newsletter.
4. Payment
€ 1200
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.