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To be Audited and Inspected

1 Day

Auditing

This interactive course with workshops is designed to provide you with the guidance and tools to always be prepared for Audits and Inspection.

Audience

Anyone interested in the requirements regarding Audits and Inspections

Time Schedule

08:30 - 09:00

Registration & coffee

09:00 - 17:00

Course (lunch included)

10:00 - 10:30

Networking & closing

Price

€ 497

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

To be Audited and Inspected

What is an audit / inspection?
What is the audit objective?
What is the inspection objective?
List of Main Pharmaceutical Regulatory References
Audit / Inspection Main steps
Audit / Inspection Approach
Whose Audit / Inspection is this?
How to prepare the Audit / Inspection?
What happens during an Audit / Inspection?
Support during the Inspection
Code of conduct
Conclusions

Participants about this course:

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3 Days

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3 Days

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Self-Inspection Management

1 Day

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

To be Audited and Inspected

1 Day

Auditing

Audience

Time Schedule

08:30 - 09:00

Registration & coffee

09:00 - 17:00

Course (lunch included)

10:00 - 10:30

Networking & closing

Price

€ 497

Location

​

Your Trainer

Program

Participants about this course:

Date

Contact Quastion for more information about this To be Audited and Inspected 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

Other courses you might be interested in:

Auditing Principles

Lead Auditor

Self-Inspection Management

Heading 6

You are signing up for:

To be Audited and Inspected

Please fill in your info below

1. Company details

Company name *

VAT-number *

Address *

City *

E-mail address *

ZIP code *

Country *

2. Participants

Select the number of participants:

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

1

First name *

Last name *

Possible food allergies or restrictions

2

First name *

Last name *

Possible food allergies or restrictions

3

First name *

Last name *

Possible food allergies or restrictions

4

First name *

Last name *

Possible food allergies or restrictions

5

First name *

Last name *

Possible food allergies or restrictions

3. Discount Code

I have a discount code

4. Price calculation

Price per participant

Number of participants

Total price

€ 497

(excl. VAT)

€ 497

discount applied

1

€ 497

€ 497

(excl. VAT)

If you use the KMO-portefeuille:

(Check if your company is qualified to use this)