Contamination Control Strategy and Revised Annex 1

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

Conducted by: Ms. Karen Ginsbury

Categories: Manufacturing, Pharmaceutical/Biologics, Quality, Regulatory Affairs, Risk Management

SKU: 221043

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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 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.

Dates:

09/02/2022
16/02/2022
23/02/2022
02/03/2022

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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 five years of experience