About the workshop
With the mandate of having a Contamination Control Strategy becoming a requirement in Annex 1 of the European Good Manufacturing Practice Regulation, the relevant companies have only until mid 2023 to comply with the regulatory implications of this guidance to continue marketing their products to the EU. So it’s not only important that companies quickly educate themselves on this guideline but also ensure that all their manufacturing practices are compliant with the standards and expectations set by the new updates.
Understanding the urgency and impact of this guidelines Treffen Media has collaborated with a world renowned expert on the subject to demystify and clarify the implications, expectations and the implementation of the Contamination Control Strategy within your organisation. This workshop aims to explain the new updates to the Annex 1, the rationale behind the updates and how it will impact your processes.
If you are currently marketing your products to the EU and fall under the ambit of these new regulations, this workshop has been specifically tailored for you.
About the trainer
Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology.
Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, validations and the requirements the manufacture of Phase 1, 2 and 3 clinical trial materials.
He is the past President and Treasurer of the Capital Area Chapter, PDA and has served as a Captain in the Medical Service Corps, U.S. Army
He has recently given presentations for organisations including the FDA, PDA, PTi, TungstenShield, IPA (Canada)
He is a member of ASM and PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.
*Discount on 2 participants is 10%, for 3-4 participants – 15% and for 5 or more – 20%
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Contact Us:
- (+91) 88490 97588
- contact@treffenmedia.com
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