25/01/2019

25/01/2019 + 22/02/2019 : “Start2Pharma 2-days: cGMP & QMS for professionals with 0 – 2 years’ experience in the industry” in Dutch

25/01/2019 8:30 am - 5:00 pm

Start2Pharma: cGMP for professionals with 0 – 2 years’ experience in the industry

Download a PDF synopsis

(Part 2 see below)

Day 1: 25/01

1. Goal of the training

This course will provide to professionals with little experience in the industry, a good overview of Regulatory context of working in a Pharmaceutical environment. The participants will become aware of the importance of working with GMPs and will learn how to find the GMPs they need. They will also learn the role of authorities, legislation & inspections in safeguarding pharmaceutical quality. This training can be an addition to the internal GMP training, where this program gives helicopter view and more background.

2. Regulations considered

FDA 21 CRF 211-210-820, FDA guidance, EU V4, SFDA, PMDA, ICH, PICS

3. Added value

This training will give you a broad background on GMP & Quality in drug manufacturing. It enables you to understand the bigger scope besides what you learn in GMP introductions in companies. The training is given by experts in the field.

Learning Objectives

At the end of the course participants will be able to

  • Know & understand the Regulatory context of working in a Pharmaceutical environment
  • Identify where these regulations come from & know which regulatory agencies are important
  • Learn the differences between law & guidance’s
  • Find the GMPs on different topics
  • Know & understand the basic GMPs important to his/her area
Scope
  • Awareness & practice
  • Introduction in GMPs where principles are learned
  • API & drug manufacturing
  • Interpretation of some general GMPs
  • Academic level
Foreseen in other modules
  • Good Documentation
  • Contamination Control
  • Interpretation on specific GMPs
  • GMPs basics for technicians and operators
  • Quality In Product Life Cycle

Program
  1. GMPs for drug products
  2. Why GMP?
  3. GMP regulations & GMP Guidelines
  4. Different Markets +  Differences between US/EU
  5. Typical expectations of FDA and European inspectors
  6. Other important standards: ICH, PICS, GAMP…
  7. Exercises on general & specific GMPs
Methodology
  • Theoretical knowledge
  • Exercises, workshops

Start2Pharma: QMS for professionals with 0 – 2 years’ experience in the industry

Download a PDF synopsis

Day 2: 22/02

1. Goal of the training

This course will provide to professionals with little experience in the industry, an overview of the importance of Quality systems in a Pharmaceutical environment & the relations between the different systems. This training is an addition to the internal QMS training, which focuses on the “how”. This training focusses more on the frameworks & background of QMS and high-level overview on how Quality is built in a drug product. In this specific session we will also teach more details on how to handle non-conformities.

2. Regulations considered

FDA 21 CRF 211-210-820, FDA guidance, EU V4, ICH

3. Added value

This training will give you a broad background in Quality Management Systems expected in API & drug manufacturing. It will enable you to understand the bigger scope. The training is given by experts in the field.

Learning Objectives

At the end of the course participants will be able to

  • Know the basic requirements of a Quality Management system and how this helps to safeguard Quality of your product.
  • Discuss ICH Q10 : Manual on QMS
  • Identify the different quality systems & their underlying relations.
  • Understand the basic principles of how Quality is built in a drug product: RA, validation, change control, process controls ….
  • Know the basics of deviation control
  • Handle non-conformities, write root causes & rationals
  • Understand where human errors come from.
  • Write a CAPA & understand the basic principles.
Scope
  • Awareness, giving helicopter view on the importance of Quality systems.
  • API & drug manufacturing
  • Practice deviation handling
  • More detailed training is foreseen in the training modules below
Foreseen in other modules
  • GDP & Technical writing skills
  • Quality In Life Cycle of drug product
  • 6Sigma: DMAIC in root cause analyses
  • Human error
  • Validation & change control training
  • Structure on Documentation

Program
  1. QMS overview
  2. ICH Q10
  3. QMS relations
  4. Quality in product life cycle:
    • RA
    • Change control
    • Validation
    • Stability
  5. Handling non-conformities
    • Root cause analyses
    • Handling deviations
    • Human error
    • CAPA
Methodology
  • Theoretical knowledge
  • Exercises, workshops

Bookings are closed for this event.

Practical information

Trainer(s): Els Staes / Natalie Mettepenningen

When: 25/01/2019 + 22/02/2019 : 8.30h – 17.00h
Where: Filip Williotstraat 9, 2600 Antwerpen

Both courses will be provided in Dutch ( GMP’s in English)

Price 2 days: 1500€/excl. VAT

Discount possible:

  • 30 % discount for early birds  (subscription before 11th January 2018)
  • Until 50% discount through KMO portfolio or training vouchers (DV.O218731)
  • Full reimbursement through Co-valent : https://www.co-valent.be/
  • 50% discount for students and PHD’s

 

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