2-Day Workshop on Aseptic Behavior and Data Integrity – From Regulator’s Perspective
Dr. Tarun Chugh
2021
Gujarat, India
India Time
This is a two-day course for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. This aseptic training course is ideally suited to management teams, industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
This workshop will help you to develop practical cost effective quality management systems through this training course for pharmaceutical industries to implement effective QMS. We know how important it is to integrate regulatory, market and customer requirements for your complete product range into a streamlined Quality Management System (QMS). Our aim is to help you protect patient health and protect your business from regulatory and commercial risk by Practical Training of quality management systems. This workshop will discuss the importance of establishing metrics, as well as, how to utilize those metrics to drive Quality Culture. This course will also discuss the latest draft guidance from the USFDA Office of Manufacturing and Product Quality (OMPQ), EU-Eudralex GMP, PIC(s) GMP and WHO-PQP.
– Understand facility and personnel requirements necessary to maintain microbial control
– Explain basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
– Understand the gowning requirements associated with different cleanroom classifications
– Explain basic principles of aseptic processing, including:
Cleanliness classifications
– Process differences between aseptically produced and terminally sterilized product
– The differences between cleaning, disinfection and sanitization
– Proper cleaning / disinfectant technique
– Elements of a robust environmental program and why EM is important
– The role of isolator technology
– The purpose of media fills, and elements critical to their success
– Identify behaviors that are or are not appropriate when working in controlled areas, and why
– Identify ways that they can impact/improve site-specific EM and aseptic behavior issues
– Quality Control Departments
– Research and Development Departments
– Regulatory Affairs Departments
– Manufacturing Departments
– Aseptic Operators
– Microbiologists
– Laboratory Professionals
– Operations Departments
– Production Departments
– Validation Departments
– Process Owners
– Documentation Departments
– Quality Auditors
– Contract Manufacturing Companies
– Sterile Product Vendors
Dr. Tarun Chugh
CEO, SIMco Pharma Consultancy
He is passionate about training and coaching people working in pharma industry in classroom and on webinar for distance location learners. Good experience for harmonization of the systems, policies, process, and work culture across various plants by standardization e.g. Quality Policy / VMP / SMF / Protocols / SOPs and documentation chronicle as per 4 level Data pyramid.
He has Good understanding of Aseptic / Terminal Sterilization tech. and microbiology requirements for clean area with non-viable / viable controls, Media fill / Smoke test (for DP and air flow patterns)/ Water generation and distribution system and its validation. Trouble shooting for pharmaceutical dosage forms (Injectable/Tablet / Capsule / Liq. / Ointment), also has sound knowledge of Validations and validation audits / documentation review.
May 6 – 7, 2021
Ahmedabad, GJ, India
Venue to be announced soon
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at info@compliancetrainings.in
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Email: info@compliancetrainings.in
Substitution Policy:
If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.
On-the-spot Registration:
We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.
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Written cancellations through email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund – minus a 20% administration fee. No cancellations will be accepted – nor refunds issued – within 10 calendar days before the start date of the event.
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Substitutions may be made at any time. No-shows will be charged the full amount.
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