2-Day Workshop on Aseptic Behavior and Data Integrity – From Regulator’s Perspective

Dr. Tarun Chugh
MAY 6 – 7
Gujarat, India
9 AM to 4.30 PM
India Time
Case Studies and Certification
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Why Should You Attend:

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 This course will also discuss the latest draft guidance from the USFDA Office of Manufacturing and Product Quality (OMPQ), EU-Eudralex GMP, PIC(s) GMP and WHO-PQP.

– Explain the difference between Aseptic and Bulk processing
– 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
– Relation of manufacturing and handling procedures to sources of product contamination
– 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 Assurance Departments
– Quality Control Departments
– Research and Development Departments
– Regulatory Affairs Departments
– Manufacturing Departments
– Aseptic Operators
– Microbiologists
– Laboratory Professionals
– Engineering Departments
– 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

Dr. Tarun Chugh has rich 30+ years of experience in Leading MNC, Indian and Middle East Co. for Quality Assurance / Control / Quality Management System / Handling Audits / Market Complaints. Vast involvement in development of Quality Systems / Quality culture of leading companies in Indian and Global MNCs for global market including USA, UK, Australia, Brazil, African Market and Canada. He has done many Audits for USFDA / MHRA / ANVISA / Canada and other EU/ ROW markets customers and third audits for multi-locations. He has Good exposure for Data Integrity handling as per Part 211 CFR Part 11 /GxP_PIC/s

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

Payment Policy:

Payment using Credit/Debit Card: Payment is required to be made at least 3 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

Payment via Bank Transfer: Registrations by Wire transfers are required to be made at least 5 business days before the date of the conference. Payments to be made in full.

Payment by Check: Registrations by Check payments are required to be made at least 10 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +91-80-4170-0521
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.

Cancellation & Refund Policy:

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.

On request by email (before the seminar) a credit for the amount paid minus administration fees could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings reserves the right to change/modify some topics, material or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

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