Course Description:

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.

Other critical aspects of this in-person training program:

  • As with any sterile product produced, this seminar will review the various methods of sterilization used for sterile processes, the critical parameters associated with each and the typical qualification exercises performed for each method.
  • Since sterile products are released based on the probability of finding a non-sterile unit, often referred to as Sterility Assurance Levels (SAL), this seminar will review current requirements for media fills, along with some of the challenges it presents.
  • The final topics to be covered will involve the requirement for change control to document, evaluate, implement and evaluate changes made to any qualified system, utility or process since changes will happen over the life cycle of these items.
  • The topic of out of specification results, often one of the most common cited deficiencies, will also be discussed as to the current FDA guidance as to what should be done when they occur.
  • The seminar will give ample opportunity for attendees to ask questions and actual case studies will be used to highlight topics where possible.
  • A well proven class activity will be used to demonstrate how to conduct an investigation on an actual sterile process deviation to see how complete the investigation was and if the class can agree on a final resolution.

Learning Objectives:

Upon completing this course participants should:

  • Understand the current regulatory requirements for sterile products.
  • Be familiar with the areas of focus that FDA auditors will look at during their audits
  • Understand the most common cited FDA deficiencies for drug manufacturers.
  • Review common areas of operator error and what each category usually indicates.
  • Review expectations for change control programs and how to investigate out of specification results.
  • Discuss the common methods of sterilization, the critical parameters for each and what items should be tested during qualification testing.
  • Review the expectations for media fills and some of the challenges faced by industry.
  • Participate in a class exercise designed to test how thoroughly a deviation is investigated in trying to determine cause and preventative actions.
  • Provide an opportunity for attendees to ask questions relating to their own company practices and recommended actions.

Who Will Benefit:

This course is designed for people tasked with maintaining and improving 21 CFR 210-211, along with department personnel listed below:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Senior management
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Legal professionals

Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • Review current regulatory guidelines (FDA and EU (European Union)) as they relate to the manufacture of aseptically produced sterile products.
  • Discuss main areas of focus during regulatory inspections and most common cited drug GMP deficiencies.
  • Review in detail the qualification activities expected of facilities, equipment, utilities and personnel.
  • Discuss the importance and methods used for environmental monitoring programs.
  • Review the various forms of sterilization, the critical parameters to be monitored and typical qualification activities expected for each.
  • Discuss the requirements for media fills as a method of proving control of the aseptic processes and personnel.
  • Review the expectations for personnel qualification and importance of gowning techniques and procedures.
  • Discuss the importance and regulatory requirements for training of employees and management.
  • Review the issue of deviations and out of specification results (OOS). Learn the expectations for the investigation of these issues. Discuss 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.

Class Exercises:

  • Review example of a change control SOP and the form used for their documentation, evaluation and approval.
  • Examine an IOQ protocol template and discuss typical information for both.
  • Constant opportunity to ask questions related to attendees current practices and to address any concerns or questions raised.

Meet Your Instructor

Kenneth Christie
Chief Operating Officer, VTS Consultants, Inc.

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the chief operating officer for VTS Consultants, Inc., located in Amherst, MA. His responsibilities specifically include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. He also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the validation manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, he serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

Mr. Christie has a BS degree in biology from Shippensburg State University (PA) and an executive MBA degree from Michigan State.

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