15/05/2017 - 26/05/2017 All Day
Start2Pharma: cGMP for professionals new to the industry
(Part 2 see hereunder)
1. Goal of the training
This course will provide to professionals new 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 for technicians and operators
- Quality In Product Life Cycle
Program
- GMPs for drug products
- Why GMP?
- GMP regulations & GMP Guidelines
- Different Markets + Differences between US/EU
- Typical expectations of FDA and European inspectors
- Other important standards: ICH, PICS, GAMP…
- Exercises on general & specific GMPs
Methodology
- Theoretical knowledge
- Exercises, workshops
Audience
Academic professionals new to the industry, and professionals who want extensive background
Practical
Language: English
Location: Plasma Industries, Neder-Over-Heembeek
Data: 0.5 day
Trainer: An De Boelpaep / Mik Staes / Bas Van Damme
Start2Pharma: QMS for professionals new to the industry
1. Goal of the training
This course will provide to professionals new 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
- QMS overview
- ICH Q10
- QMS relations
- Quality in product life cycle:
- RA
- Change control
- Validation
- Stability
- Handling non-conformities
- Root cause analyses
- Handling deviations
- Human error
- CAPA
Methodology
- Theoretical knowledge
- Exercises, workshops
Audience
Academic professionals new to the industry, and professionals who want extensive background
Practical
Language: English
Location: Plasma Industries, Neder-Over-Heembeek
Data: 1.5 day
Trainer: An De Boelpaep / Mik Staes / Bas Van Damme
Bookings are closed for this event.