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  COURSE 2

GMP Case Studies Pharma



Target Group

Staff who work in a pharmaceutical production facility in the areas
  • Solid forms
  • Liquid forms
  • Sterile medicinal products
Prior Knowledge:
Good prior GMP knowledge is required.

Languages available:
Dutch, German, English, French, Italian and (Mandarin) Chinese.

Implementation:
Using videos from GMP facilities!

Study Time:
5 hours
(Part 1 2.5 hours and Part 2 2.5 hours)

Questions to:
Phone: +49(0)6221 / 84 44 0 - e-Mail: info (at) concept-heidelberg.de

BOOK THIS COURSE (€ 325)

BOOK Part 1 (€ 190)

BOOK Part 2 (€ 190)

WATCH DEMO

Do you want to book this course for more than 10 employees?
Send us an inquiry with the title of the course and the number of participants. We will make you a special offer.


Details

As an employee in the quality assurance department at Pharma Co, you will assist your colleagues in resolving GMP deficiencies. This course consists of 14 different cases. Each case analyses a production incident such as a mix up, a contamination and a FDA-warning. The trainee must find the GMP-violation(s) causing the incident by using a checklist during the investigation. The trainee is given access to extra video fragments and documents (batch records, logbook information), which might contain the mistakes. After each case an instruction is given about the GMP rules which have been violated. Each case ends with a test.

Certificate
Attendance certificate from CONCEPT HEIDELBERG

Costs - individuals
Part 1: Case studies 1 to 7: € 190 plus VAT.
Part 2: Case studies 8 to 14: € 190 plus VAT
All 3 parts: € 325,- plus VAT

Costs - company licence
Companies which yearly train more than 50 employees can aquire a company licence. Depending on the use, courses can be carried out for under € 30,- per training hour.

    The following case studies are covered:
    1. Broken vials during transport
    - NDA-approved suppliers
    - Dealing with complaints
    2. Missing tablets in a blister pack
    - Verification before start-up
    - Documenting deviations
    3. An exceeded expiration date for tablets
    - Preparing and filing documents
    - Instruction of operators
    4. A deviating content in freeze-dried preparations
    - Document revision
    - Batch records
    5. Tiny metal particles found in ointment
    - Contamination
    - Reporting deviations
    6. An out of specification temperature in the autoclave
    - Validation
    - Calibration
    - Microbial contamination
    7. Sudden increase in particle rate in clean room
    - Non-viable particle monitoring
    - Maintenance and repairs
    8. Contaminated media during sterile challenge
    - Monitoring of the process
    - Microbial checks and monitoring
    - Cleaning in clean rooms
    9. Contaminated WFI sample
    - Disinfecting and sterilisation
    - Design and construction of equipment
    - Revalidation
    - Monitoring water
    10. Deviating analytical results just after validation
    - Calibration and validation
    - Communication
    - The log
    11. A warning during an FDA inspection
    - Inspection
    - Quality assurance
    12. A foreign tablet in a bottle
    - Line-clearance
    - Accountability
    13. One of two containers is contaminated just before filling
    - Materials reception
    - Labelling
    14. A deviating pH during lab test
    - Cross contamination
    - In-process-checking

Study time: 5 hours

BOOK THIS COURSE (€ 325)