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Compliance Seminars®

Pharmaceutical process equipment

Cleaning validation of pharmaceutical process equipment

- New GMP requirements
- What about PDE
- Define your best strategy
- Methods and techniques


Major update!

This course now includes the following GMP expectations:
  • EU GMP Part 1, Chapter 3 and 5 (03/2015)
  • EU Annex 15, Qualification and Validation (10/2015)
  • Integration of PDE Value according to lastest official texts :
    • EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
    • Questions & answers and Outcome associated to this official text
Some important modifications linked:
  • Latest draft of New Annex 1 (02/2020)
  • EU GMP Part 4
  • EU GMP Part 2

 

Course description:

The state of control regarding our cleaning processes is a constant issue by our regulators. Beyond purely "compliance" issues, it is a major point for control of the manufacturing process. This course is intended for manufacturers of final dosage pharmaceuticals, active pharmaceutical ingredients, and intermediates, as well as for biotech companies and R&D.

This course is constantly updated according to state of the art and the changing CGMP expectations, focused on the aspects of technical and regulatory (US and EU) updates associated with validation of cleaning processes. Update are performed also according to guidelines or other important texts (PDA, ISPE, APIC, etc.).

Objectives

The course will provide the attendees with a better knowledge of regulatory requirements and techniques to be able to build their own cleaning validation strategy in accordance with current US regulations and to get the most effective “payback” in terms of productivity, safety, ergonomics and environment protection.

Methodology

This course proposes deep details for all part of the global cleaning validation strategy in pharmaceutical activities. Biotechnology activities are also treated. Using examples and practical exercises, linking together techniques, quality assurance and compliance with FDA/EU requirements.
At each step, the regulations are recalled and interpreted into operational and achievable recommendations.

Course outline

  • Key points of US and European cGMP’s
  • Principle, definition and scope of cleaning validation
  • Cleaning validation prerequisites (team and people, equipment and utilities qualifications, etc.)
  • Cleaning development and cleaning optimization
  • Definition of critical surfaces and sampling plan
  • Definition and use of equipment train
  • Definition of worst case equipment and worst case product
  • Choice of tracers according to different contaminants
  • Calculation of acceptance criteria according to new regulatory aspect for pharmaceutical processes, APIs, Biotechnology activities
  • The choice of sampling methods according to different contaminants
  • Analytical methods linked to sampling methods
  • Number of cleaning validation runs
  • Documentation expectations at each step (cross contamination risk assessment, validation master plan, SOP’s, protocols & reports…)
  • How to follow the validation: Monitoring, change control and potential revalidation
  • Conclusions

Learning objectives:

At the end of this course the participants will have acquired the knowledge necessary for the rational and compliant implementation of a cleaning validation program for manufacturing equipment on pharmaceutical, cosmetic, biotechnology or chemical sites, from clinical to manufacturing batches.

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Bring this course in-house?

Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?

 If so, running the course in-house is probably the best and most cost effective solution.

Make an enquiry

 

Register  

 

Comments from our participants:
"The instructor was great!"
"The course leader was really nice and knows his topic."

 

Course facts

Course no:
5220
Industry:
Pharmaceuticals

Level:
Intermediate / Advanced
GMP region:
US and EU

Language:
English

Instructors:
Pierre Devaux  Christophe Gamblin
Pierre Devaux and Christophe Gamblin, Theraxel - Point Forty Five

Date, location and venue:

16-17 December, Amsterdam
Double Tree Hilton, Centraal Station
Oosterdoksstraat 4    

Register by 4 November - Save € 200

This course is offered in-house.
Click here for more info and inquiry form.


Time:
2 days
09.00-16.30 (Registration 08.30-09.00, day 1)

Price (excl. local VAT):
Register by 4 November - Save € 200
Until 4 Nov: 13 780 DKK (€ 1 850)
From 5 Nov: 15 280 DKK (€ 2 050)
incl. course material (pdf), lunches and refreshments

Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.

Discounts:
For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.


Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
3-5 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 14 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.