A Vision of your New and Improved
2022 Cleaning Validation Process


December 9th, 2021

9:00 AM – 10:00 AM EDT

Enter 2022 with the latest knowledge of automating your cleaning validation process and meeting regulations such as Data Integrity. Many are worried about updating their cleaning validation process to meet the latest Annex 1 and other regulations.  You will learn how automation can help you setup your process and how you can continuously optimize your process without having to spend weeks or months of your resources’ time. We will also cover the typical manual process risks of cross-contamination, and how automation can assist in alleviating these risks.

Top Benefits:

  1. Meet the latest regulations on cleaning validation from ISPE, PDA, EMA, FDA including Annex 1 and Data Integrity
  2. Minimize cross-contamination risk in your process
  3. Gain time to optimize your process with automation tools

SPEAKERS


Ilona Endisch

Associate Director, Product Innovations – North America, Novatek International


Ilona Endisch, BCompSc., is the Associate Director of Product Innovations at Novatek International, with over 20 years of experience in regulated industries. Ilona works with clients, partners, regulatory agencies, consultants, and other experts world-wide to assist in improving quality processes.  Ilona is involved with industry training,  developing user requirements, performing process mapping and identifying and managing new product innovations for quality software including contamination control software. Ilona is active in the industry, giving presentations and performing trainings in topics related to software, microbiology, quality management, cleaning validation, risk assessment, and other areas. Ilona is currently teaching a class on Trending as part of the Aseptic course given by the PDA-TRI.


Dr. Tim Sandle

Ph.D., Department Head – Compliance and Quality Risk Management, BPL, Ltd.


Dr. Tim Sandle Ph.D., is a pharmaceutical microbiologist, with over 25 years of experience, who has worked for different healthcare organizations and pharmaceutical companies, in microbiology and broader quality roles. Dr. Sandle currently works for an international sterile products manufacturer and he is additionally a visiting tutor with the University of Manchester (lecturing in pharmaceutical microbiology), a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig), and a supporter of several other societies relating to pharmaceuticals and healthcare, including IVT. Dr. Sandle also serves on a number of advisory committees and standards boards. Dr. Sandle has written or edited over 25 books, more than 100 book chapters, over 125 peer reviewed papers and some 400 technical articles. Dr. Sandle is a regular presenter at conferences and webinars, having delivered over 150 presentations.