Aseptic Processing, Validation and Challenges – From Regulator’s Perspective

2-Day In-Person Seminar (Code – INDSEM121)

Aseptic Processing, Validation and Challenges – From Regulator’s Perspective

    Ahmedabad, GJ, India


    April 18 – 19, 2019

Seminar DescriptionObjectivesAgendaPricingVenue
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.

Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety. This course will also review the guidance provided in USP <1116> to ensure compliance with regulatory expectations are met.

Why You Should Attend:

The manufacture of aseptically produced sterile products represents the greatest level of risk to the public and as a result there are numerous requirements that companies must abide by for compliance. This training will cover not only the current regulations as set by the FDA but also those required by the European Union (EU) GMPs. This will include the main areas of focus by regulatory auditors, expectations for the qualification of equipment and utilities, along with environmental monitoring, media fills and personnel qualification to name a few.

As expected, training of both personnel and management is an increasing area of concern and this seminar will review some proposed reasons for operator error that regulators review to help determine other quality systems that may be impacted depending on the category to which operator error is associated with. Actual cases will be highlighted for some of the reasons listed.

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.

Learning Objectives:

  • 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

Who Should Attend :

  • Quality Assurance Management and Staff
  • Quality Control Management and Staff
  • Research and Development Management and Staff
  • Regulatory Affairs Management and Staff
  • Manufacturing Management and Staff
  • Engineering Management and Staff
  • Operations Management and Staff
  • Production Management and Staff
  • Validation Management and Staff
  • Process Owners
  • Documentation Management and Staff
  • Quality Auditors

DAY 1 : (8.30 AM – 5 PM)

Registration: 8.30 AM – 9 AM

What Regulatory is demanding today

  • Latest regulatory requirement of FDA and EU (European Union) guidelines for manufacturing of aseptic process
  • What regulator see on site during regulatory inspections and most common cited drug GMP deficiencies
  • Review in detail the qualification activities expected of facilities, equipment, utilities and personnel and data integrity (ALCOA+)

Microbiology – Main strength

  • The role of environmental monitoring
  • Types & sources of microorganisms
  • The impact of microorganisms on product and patient health and safety
  • Methods used for environmental monitoring programs

Aseptic Process – Important traits

  • Cleanliness and disinfection
  • Terminal sterilization vs. Aseptic Processing
  • Relation of manufacturing and handling procedures to sources of product contamination
  • The differences between and the purposes of cleaning, disinfection and sanitization
  • Proper cleaning tools and techniques
  • The role of isolator technology

Q&A and Networking: 4.30 PM – 5 PM

DAY 2 : (9 AM – 4.30 PM)

Clean Area Behavior – Training and monitoring

  • How to gown properly
  • Personnel behavior in a cleanroom – Human as a source of contamination and errors
  • Practices – Do and Don’t
  • How to review -EM/aseptic behavior observations/risks/OOS/OOT
  • Importance of personnel training and control of microbiological contamination

Discussion: Ways to change/improve/eliminate these behaviors & risks

Aseptic Validation – Media Fill and importance

  • The purpose of media fills, and elements critical to their success
  • How to Perform a Successful Media Fill
  • Sterile Filtration Validation Requirements

Handling Deviations & OOS/OOT – Proper investigations

  • Issue of deviations and out of specification results (OOS)
  • Expectations for the investigation of these issues
  • Categories being discussed to classify the reasons for operator error


  • Discuss the importance and expectations for a change control program as a method of assuring a state of control
  • Review example of a change control SOP and the form used for their documentation, evaluation and approval.

Q&A, Certification, Networking and Close: 4 PM – 4.30 PM


Seats and Accommodation are limited and based on first-come, first-serve


Fortune Landmark – Ahmedabad

Ahmedabad, GJ, India | April 18 – 19, 2019

Call for Assistance: +91-80-4170-0521   Register Now