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 requirements applicable in production and distribution of medicinal products. The course aims to provide an educational and reference tool for anyone interested in the process of auditing, and secondly, an overview and practical advice on performing audits. The main focus is put on GDP and GMP environments: distributors, warehousing, transport and repackaging site; and production of medicinal products.
Audience
Anyone interested in auditing principles
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
Price
€ 2430
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
Audit Definition
-
What's an audit?
Lead Auditor Responsibilities
-
Description responsibilities
-
Audit Team Member's Role
Ethical Standards, Conflict of Interest
-
Perception
-
Conflict of interest
-
Gifts
-
Confidential Information
Regulatory Standards
-
Local, Europe, US
-
Federal and State Law
Types of Audit
-
System
-
Compliance
-
Product
-
Process
Audit Purpose and Benefits
-
Process overview
-
Audit Program Elements
-
Benefits
Audit Terminology
-
Frequently used terms/principles
Cultural Awareness
-
Workshop 1: Code of conduct in different countries
Audit Planning and Preparation
-
Guidance on planning and preparation
How to use Checklists as a Tool
-
Guidance on checklists
Scheduling of the Audit
-
Guidance on how to schedule an Audit
Audit Agenda
-
What should be placed on the agenda?
-
Workshop 2: Preparing an audit agenda
Awareness for Detecting Fraud and Counterfeiting
-
Challenges
-
Definitions
-
Detection of Fraud
Auditor Preparation and Selection
-
Audit Team
Opening Meeting, Audit Performance and Inspection Technique
-
Guidance on content opening meeting
-
Do's and don'ts
-
Questioning techniques
-
Collecting information
-
Workshop 3: Questioning techniques
-
How to take notes in an efficient way
Audit Observation
-
How to describe observations
-
Categorization of observations
-
Workshop 4: Observations categorization
Closing Meeting
-
Guidance on content closing meeting
-
Workshop 5: Closing meeting
Audit Report writing from Legal Perspective
-
Report writing
-
Workshop 6: Report writing
Corrective Action Analysis
-
Process and improvements
Supplier Risk Plans
-
How to mitigate risk
Audit Closure
-
Closure approach
Participants about this course:
Heading 6
Date
Date 1
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:
Auditing Principles
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
€ 2430
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.