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Annex 1 – with a focus on sterile product manufacture and contamination control strategies

Description

This course is designed to provide attendees with a comprehensive understanding of eudralex Annex 1 regulations, contamination control strategies and techniques used to maintain sterile processes. Attendees will have the opportunity to evaluate their knowledge through interactive group activities, discussions and assessments. Upon completion of this course, attendees will be more confident in implementing eudralex Annex 1 requirements effectively in their facility.

 

Why you should attend this training?

 

At the end of this course attendees will be able to:

  • Understand eudralex Annex 1 requirements and their implications in the manufacturing process
  • Comprehend what is required for contamination control strategy
  • Evaluate the quality risk assessment and its role in pharmaceutical product development
  • Analyse validation studies related to eudralex Annex 1
  • Recognise personnel training needs in sterile production processes
  • Distinguish between different types of contamination control equipment
  • Explain the importance of environmental monitoring in eudralex Annex 1
  • Examine technical documentation requirements for eudralex Annex 1
  • Demonstrate techniques used to prevent cross-contamination and maintain sterile processes
  • Implement corrective and preventive action plans when needed

 

ANNEX1 EVENT - EARLY BIRD TICKET

ANNEX1 EVENT - EARLY BIRD TICKET

599

Livestreaming Zoom _____ ✔️ Interactive Lectures _____ ✔️ FREE Recorded Webinar One Month Access _____ ✔️

18/50

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ANNEX1 EVENT - EARLY BIRD TICKET

Who should attend?

Target Audience: This course is aimed at advanced level attendees with basic knowledge and experience in eudralex Annex 1 regulations, as well as a clear understanding of microbial contamination control measures. It is suitable for all personnel working in sterile product manufacture

  • Quality Assurance Managers
  • Production Managers
  • Validation Engineers
  • Microbiologists
 
 

About the trainer

Paul Palmer – Pharmaceutical Director

Paul Palmer

Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person since 2004. He has over 36 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.

Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.

Qualified as a Lead auditor, Paul has been auditing suppliers and internal management systems since 1998 and still remembers the advice of his manger Robert Whitham on his first solo audit. Remember not everyone does GMP the same way, just because they don’t do it the same way as us doesn’t mean its wrong. Seeing new ways and applying the knowledge to other fields or companies allows Paul to think laterally often developing a creeative solution noone else considered.

People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.

Educationally Paul has a Degree in Applied Biology, an MSc in Quality Management, a Post Graduate Diploma in Pharmaceutical Studies and an EMBa in Business administration all of which bring more depth to his experience and knowledge.

8:45 am - 9:00 am Online

Connecting to webinar

9:00 am - 9:30 am Online

Introduction to eudralex Annex 1

Overview of eudralex annex 1 regulations and its implications on sterile product manufacture.

9:35 am - 10:20 am Online

Contamination Control Strategy:

Understand what is required to develop a contamination control strategy and assess the risks of product contamination.

10:20 am - 10:35 am Online

Coffee break

10:35 am - 11:20 am Online

Quality Risk Assessment

Evaluate the quality risk assessment process and its importance in ensuring eudralex Annex 1 compliance.

11:25 am - 12:10 pm Online

Validation Studies

Analyse validation studies related to eudralex Annex 1 and review their outcomes.

12:10 pm - 12:25 pm Online

Coffee break

12:25 pm - 1:10 pm Online

Personnel Training

Recognise personnel training needs for sterile production processes, according to eudralex Annex 1 requirements.

1:15 pm - 1:45 pm Online

Q&A session with trainer

8:45 am - 9:00 am Online

Connecting to the webinar

9:00 am - 9:45 am Online

Contamination Control Equipment

Distinguish between different types of contamination control equipment and their application in eudralex Annex 1 compliant operations.

9:50 am - 10:35 am Online

Environmental Monitoring

Explain the importance of environmental monitoring in eudralex Annex 1 and its role in product contamination prevention.

10:35 am - 10:50 am Online

Coffee break

10:50 am - 11:35 am Online

Technical Documentation

Examine technical documentation requirements for eudralex Annex 1, understand how to create documentations that comply with eudralex regulations.

11:40 am - 12:25 pm Online

Cross-Contamination Prevention

Demonstrate techniques used to prevent cross-contamination and maintain sterile processes during eudralex Annex 1 compliant operations.

12:30 pm - 1:15 pm Online

Corrective & Preventive Actions

Implement corrective and preventive action plans when needed, according to eudralex Annex 1 regulations.

1:15 am - 1:45 am Online

Q&A session with trainer

  • Date : June 28, 2023
  • Time : 9:00 am - 1:00 pm (UTC+0)
  • Reg. Deadline : June 27, 2023 12:00 am
  • Venue : Europe

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