"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Pharmaceutical process equipment

Cleaning validation of pharmaceutical process equipment

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

From 2000 to 2010 around 35% of the "Warning Letters" from the FDA contained remarks on cleaning and cleaning validation!


Major update!

This course now includes the following GMP expectations:
  • ICH Q3D, Elemental Impurities (12/2014)
  • EU GMP Part 1, Chapter 3 and 5 (03/2015)
  • EMA Guideline: Health based exposure limits for use in risk identification in the manufacture (11/2014)
  • EU Annex 15, Qualification and Validation (10/2015)
Some critical changes:
  • the PDE approach
  • the safety factors
  • the use of R&D data

 

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. The course content is based on the cross-over experiences of Mr. John Lee (former FDA investigator) and Mr. Frédéric Laban (senior international consultant) on the subject, particularly on the most recent statements from the FDA, the recommendations of SFSTP and APIC;  and the current EU GMPs.

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

Using examples and practical exercises in groups, 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
  • Which cleaning methods must be validated
  • Key times and key durations linked to cleaning validation
  • What contaminant search?
  • Calculation of acceptance cleanliness level for pharmaceutical processes, APIs, Biotech…
  • The choice of Sampling methods; which method for which case, and justification
  • Analytical methods linked to sampling methods
  • What to do for CIP, semi automatic cleaning systems and manual cleaning
  • Validation strategies (worst cases, bracketing….)
  • The documentation (validation master plan, SOP’s, reports…)
  • How to follow the validation: Monitoring, change control and revalidation
  • The prerequisites:
    • Qualification of means
    • Qualification of people
    • Optimisation of cleaning procedures
  • 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 or chemical sites, from clinical to manufacturing batches.

Gate2GMP®

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »

 

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  

 

Rating and comments:
4.4 of 5
"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
Instructor:
Frédéric Laban
Mr Frédéric Laban

Date, location and venue:

November 21-22, 2017, Copenhagen, Denmark
DGI-byen
Tietgensgade 65    
(Entrance from Kvægtorvsgade)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Webers (500m)
» Scandic Copenhagen (800m)

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


Time:
2 days
8.30-16.30 (Registration 08.00-08.30, day 1)

Price (excl. local VAT):
14 400 DKK (€ 1 925) 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 we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
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.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
* If you still want a printed course handouts binder from us, we charge 50 Euro/pcs (of which 10 Euro to TRINE for clean energy projects)

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 7 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.