Annex 1 (Practical Implementation of a Contamination Control Strategy) | Pharma Training Course | PCS Academy

Search across the website

Find training courses, blog posts, guidelines, knowledge base articles and more.

to navigate esc to close to open

Annex 1 (Practical Implementation of a Contamination Control Strategy)

Provide direction for the preparation and updating of the Contamination Control Strategy.

Practical GMP & GDP training for pharma and biotech professionals — taught by senior PCS consultants who advise manufacturers on real GMP issues every week.

  • Language:
    Dutch flag
  • 1 day in total

0 ex. VAT

Registration is closed.

Registration closed

Awaiting approval? Pre-register now — no obligation Open
This training contains:
  • Accreditation for ziekenhuisapothekers (NVZA), 7 Accreditation points
  • Lunch
  • Digital copy of materials
  • Training certificate

    • What you will be able to do after this course

    Provide tools for drawing up a CCS and gap analysis

    Provide tools for keeping the CCS and gap analysis up to date

    Gain knowledge of producing sterile pharmaceutical products

    Upcoming dates — pick a seat

    Dates Language Price Register
    No open dates scheduled right now. Check back soon, or contact us to request a date or an in-house run for your team.

    About this course

    What this course covers

    Since the new Annex 1: Manufacturing of Sterile Medicinal Products has been published, no one in the pharmaceutical industry can ignore it.

    For all companies that manufacture sterile pharmaceutical products, having a Contamination Control Strategy is a requirement.

    Although Annex 1 mentions many aspects that must be described in such a Contamination Control Strategy, the annex provides little guidance on how such an important document should be written. This one-day course provides guidance on drawing up and keeping the Contamination Control Strategy up-to-date.

    In addition, various aspects of producing sterile products are discussed, such as cleanrooms, water, gases, sterilization, environmental monitoring and medium simulations. Attention will also be paid to possible risks for sterile products.

    Who this course is for

    This training is intended for anyone who wants to understand the purpose of a Contamination Control Strategy and/or for those who need to develop and maintain Contamination Control Strategy documents.

     

     

    This training is also suitable for ziekenhuisapothekers, who will receive professional accreditation points.

    What you take back to work

    • Understanding the Intent of a Contamination Control Strategy
    • Learn how to draw up and maintain a Contamination Control Strategy
    • Understanding Where the Risks Are in Producing Sterile Products

    Contents

    • The Process,
    • The Facility,
    • Utilities,
    • Equipment,
    • Personnel,
    • Disinfection,
    • Sterilization Techniques,
    • Materials,
    • Environmental Monitoring,
    • CCS Aseptic Process Simulation,
    • QC & Release,
    • Lifecycle,

    Program

    Practical Information

    Accreditation:
    • Ziekenhuisapothekers (NVZA), 7 Accreditation points
    Difficulty / Level:
    Intermediate level and Professional level
    Group discounts:
    • 2 participants - 5%
    • 3 participants - 10%
    • 4 participants - 15%
    • 4 participants - 20%
    • 6+ participants - 25%

    Group discounts are only applicable when multiple participants register for the same course at the same time.

    Language (upcoming edition):
    • Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
    Learning form:
    Classroom
    Times:
    To be announced.

    Lecturer

    Your trainers are practising PCS consultants. They spend most of their week helping pharma manufacturers respond to real GMP findings, audits and inspections — and bring that experience straight into the classroom.

    Wilma Meijs avatar

    Wilma Meijs

    Trainer

    Wilma Meijs is an experienced consultant and director with more than 25 years of experience in th...

    Tags

    Change Control GMP EudraLex Volume IV Manufacturing CCS Sterile Aseptic

    Reviews (17)

    4 out of 5 stars

    Based on 17 reviews

    Review data

    5 star reviews

    47%

    4 star reviews

    53%

    3 star reviews

    0%

    2 star reviews

    0%

    1 star reviews

    0%

    5 out of 5 stars

    Strong points (and why):

    Zeer goede post-master nascholing, goede trainer met veel ervaring en een duidelijk overzicht van een complexe GMP Annex

    Michiel van den Herik - QP/RP

    4 out of 5 stars

    Strong points (and why):

    Inhoudelijk veel behandeld!

    To be improved:

    Sheets vooraf delen ivm aantekeningen maken

    Review:

    Lekkere lunch, fijne cursus.

    Marica Smits - Apotheker

    5 out of 5 stars

    Strong points (and why):

    Wilma geeft het onderwerp handen en voeten op een zeer prettige manier.

    Martijn Kooij - QP

    4 out of 5 stars

    Strong points (and why):

    Veel interactie, zowel onderling als met de trainer. Goede praktijk voorbeelden en goede relatie met wat schrijf je in de CCS en waar verwijs je

    Tjitske - Ziekenhuisapotheker

    4 out of 5 stars

    Strong points (and why):

    Interactief ondanks veel theorie

    Anonymous - Manager manufacturing support

    4 out of 5 stars

    Strong points (and why):

    Volledig

    Anonymous - Anonymous

    5 out of 5 stars

    Strong points (and why):

    Heel duidelijk, interactief en leerzaam

    Jet Albers - Productie Engineer

    5 out of 5 stars

    Strong points (and why):

    Interactieve met leraar en andere studenten

    Ashleigh Murphy Schafer - Sterility Assurance Specialist

    5 out of 5 stars

    Strong points (and why):

    Goed, tempo prima

    Anonymous - Anonymous

    4 out of 5 stars

    Strong points (and why):

    Goed gedoseerd, duidelijk uitgelegd, voldeed aan de verwachtingen, locatie perfect

    Review:

    Geen Geen

    Anonymous - Manager QC

    5 out of 5 stars

    Strong points (and why):

    Interactief

    Anonymous - Anonymous

    4 out of 5 stars

    Strong points (and why):

    Dat ze ons zelf liet nadenken welke onderdelen belangrijk zijn om te beschrijven in CCS, en hoe je moet onderbouwen wanneer je iets niet doet zoals in de annex 1 staat. Ik heb een aantal dingen ontdekt waar wij bijvoorbeeld nog een risico analyse bij moeten schrijven.

    Anonymous - Productie apotheker

    Related courses you may also need

    Middenkader image

    GMP for Mid-Level Management in the Pharmaceutical Industry

    Based on 963 participants

    € 2685.00 ex. VAT
    Good Writing image

    Good Writing Practices

    Based on 128 participants

    € 1197.00 ex. VAT
    GDP Refresher image

    GDP for the QP/RP Refresher

    € 1197.00 ex. VAT
    GDP training image

    Good Distribution Practices (GDP) – also for the Responsible Person (classroom)

    Based on 408 participants

    € 1997.00 ex. VAT
    Audits zelfinspectie image

    External Audits & Self-inspections

    Based on 405 participants

    € 1997.00 ex. VAT
    Steriele Productie image

    Quality Management in Sterile Manufacturing

    Based on 455 participants

    € 2719.00 ex. VAT
    training image

    0 ex. VAT

    Registration is closed.

    Registration closed

    Awaiting manager approval? Pre-register now. It's free and without obligation. We'll hold your interest and follow up when you're ready to confirm. Pre-register — no obligation
    Difficulty:
    Intermediate level Professional level
    This training contains:
  • Accreditation for ziekenhuisapothekers (NVZA), 7 Accreditation points
  • Lunch
  • Digital copy of materials
  • Training certificate
    • Training 5 or more people from the same site?

    Bring this course in-house. We deliver more than 100 GxP courses on-site, tailored to your products, SOPs and inspection history.

    Request in-house quote