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Contamination Control Strategy and Revised Annex 1A Risk Based Approach to Management of Sterile Products

Conducted by: Ms. Karen Ginsbury
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The second draft of EU Annex 1 is scheduled to be released for public comment by March 2020.  The first draft resulted in over 6000 comments.  In this two day course we will develop an Annex 1 roadmap, working in small groups to distill best practices for aseptic processing and manufacture of sterile products using a risk based approach as...Continue reading

The second draft of EU Annex 1 is scheduled to be released for public comment by March 2020.  The first draft resulted in over 6000 comments.  In this two day course we will develop an Annex 1 roadmap, working in small groups to distill best practices for aseptic processing and manufacture of sterile products using a risk based approach as described in ISO 9001:2015, starting with the context of the organizations in which you currently work.  We will understand what a Contamination Control Strategy (CCS) is and how to use practical and useful risk assessments to develop the CCS.  Once developed, effective monitoring and improvement become elements which must be constantly nurtured.

Objective: 
Using the draft revised Annex 1 as a shell to provide chapter headings, we will develop our own best practices roadmap for an ideal Annex 1.
This is a must participate workshop for any company performing aseptic processing or overseeing contractors performing this type of manufacture on their behalf.

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Dates: 
  • 09/02/2022
  • 16/02/2022
  • 23/02/2022
  • 02/03/2022
Course location: Zoom Course
Duration: 2-Days Course
Hours: 10:00 - 13:30
Credits: 2
Course Language: עברית

Course price: ₪3,600 Including VAT
Early registration is Closed
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Issues to be covered

  • Annex 1: current status and review
  • Context of your company / organization
    how do we fit into Annex 1
    e.g. aseptic preparation vs aseptic processing vs terminal sterilization or non-sterile product; CMO vs virtual company; ATMP – excluded?
  • Process mapping
  • 6 M’s mapping
  • Risk Assessment vs mitigation and monitoring
  • Risk communication and Risk Reducing Factors: Culture?
  • Personnel: education and competency: job description, CV, skills function matrix, OTJ training, human error reduction program; gowning qualification
  • Premises, Equipment, Utilities
    e.g. what class should an airlock be: PAL vs MAL; barriers, HVAC design
    Validation including filters PUPSIt , extractables and leachables, SAL, aseptic process simulations
  • Maintenance vs Repairs
  • Cleaning and Disinfection
  • Low endotoxin / bioburden starting materials / process components
  • Production and adoption of new / state of the art technology
  • PW, WFI, clean steam, air, gases
  • Environmental Monitoring (viable and total particles)
  • TO DO list to take away

Who should attend

Anyone working with sterile products, aseptic processing in the pharmaceutical, biotech and/ or API industry including contract manufacturers and testing laboratories, and for the consideration of non-sterile product manufacturers as some of the elements are relevant.

QPs, Quality Assurance, Quality Control and other quality professionals, Operations Managers, production managers, Research and Development, persons working in technology transfer, Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course very useful.

Virtual companies who must oversee and QPs who must release sterile / aseptic products will need to attend

Benefits to the Participants

In addition to understanding what the regulators are focusing on, participants will come away with best practices and a genuine and stream-lined, best practices approach to aseptic processing.  There may be some surprises (provocative clue: do we still need an autoclave?)

About The Lecturer

Karen Ginsbury
B.Pharm, M.Sc, MRPharmS, has over twenty years of experience in
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