Practical Considerations for Implementing a GMP Annex 1 CCS Webinar
Practical Considerations for Implementing a GMP Annex 1 Contamination Control Strategy (CCS) Webinar Training Series

Gain knowledge from vetted, subject-matter experts on...

It is recommended that all interested professionals take the two introduction classes. After these two training classes have been completed you may take whichever additional modules you would like in no particular order.


Introduction Modules

Scope and Principle of GMP Annex 1
 

A significant change in requirements, recommendations and detailed specifications are included in the GMP Annex 1 drafts. While the intent of Annex 1 is to provide guidance for the manufactures of sterile products; some of the principles and guidance such as a Contamination Control Strategy (CCS), facility design, cleanroom classification, qualification, monitoring, and personnel gowning may be used to support other medical product manufacturing.

This session will include:

  • Brief history of the document and the reasons behind the updates.
  • Discussion regarding the scope and its extension into non-sterile manufacturing.
  • Introduction to the various sections of the CCS

Why you should attend:

  • Become familiarized with updated current regulatory thinking.
  • Learn from case histories regarding international regulatory observations.
  • Be prepared for future inspections, audits and regulatory expectations.
    • Learn from industry experts who have the knowledge and experience in developing science and risk based contamination control strategies for all types of medicinal products.

Instructor

Morgan Polen (View LinkedIn Profile)

Morgan Polen has been involved with cleanrooms and contamination control since 1984. He has worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, AFV, monitoring program development, particle counter design, and product management for cleanroom related products and systems.  He has addressed monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical, and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards.

Upcoming Training Date(s):
December 7, 2021
12 - 2 p.m. Central Time
Early-bird discount ends November 12th. Use coupon code EB1221GMP when checking out to save 10%.
Click here to register online now
Download the print registration form
Pricing:

Regular (through 12/6)

Member Regular: $98
Nonmember Regular: $150

Last Chance (if space is available after 12/6)
Member Last Chance: $123
Nonmember Last Chance: $183

 

Premises and Equipment of GMP Annex 1
 

Cleanrooms are high technology environments designed to control and limit airborne particles and other types of contamination. The International Organization for Standardization (ISO) has a series of standards for cleanrooms and contamination control.  These standards are a baseline that is applicable for all industries. Cleanrooms used for medical products such as pharmaceuticals have additional requirements (beyond cleanrooms used in other industries) and regulations that apply to the design, construction, qualification, and operation. GMP Annex 1 introduces a grade system related to cleanroom occupancy states that utilizes the ISO 14644 series of standards but places particle and microbial limits assigned to each grade based upon the occupancy state of each grade.

Additionally the qualification testing of cleanrooms in Annex 1 calls for very specific testing such as:

  • Installed filter leakage and integrity testing.
  • Airflow measurement - Volume and velocity.
  • Air pressure difference measurement.
  •  Airflow direction and visualisation.
  • Microbial airborne and surface contamination.
  • Temperature measurement.
  • Relative humidity measurement.
  • Recovery testing.
  • Containment leak testing.

This 3-hour module will address:

  • Cleanroom concepts
  • Cleanroom and barrier system integration
  • Door openings and ingress of contamination
  • Passthrough designs
  • Airflow disruptions due to to inadequate cleanroom design
  • Case studies and regulatory observations related to cleanroom flaws that have led to environmental monitoring excursions, media fill failures, product failures, regulatory observations, warning letters , import alerts and patient harm.

Why you should attend:

Current revision of GMP Annex 1 has greatly expanded the section of cleanrooms and clean air devices purporting contamination control from design phase. This scientific approach helps understand cleanroom design requirements that need to be addressed to meet the contamination control effect of cleanroom air. This module will provide guidance through real-time case studies and regulatory observations to bring home the importance of a good cleanroom design and airflows to protect product contamination and patient harm.

Instructor

Morgan Polen (View LinkedIn Profile)

Morgan Polen has been involved with cleanrooms and contamination control since 1984. He has worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, AFV, monitoring program development, particle counter design, and product management for cleanroom related products and systems.  He has addressed monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical, and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards.

Upcoming Training Date(s):
December 8, 2021
12 - 3 p.m. Central Time
Early-bird discount ends November 12th. Use coupon code EB1221GMP when checking out to save 10%.
Click here to register online now
Download the print registration form
Pricing:

Regular (through 12/6)

Member Regular: $225
Nonmember Regular: $285

Last Chance (if space is available after 12/6)
Member Last Chance: $275
Nonmember Last Chance: $335

 

Supplemental Modules

Cleaning and Disinfection
 

This module provide a roadmap to the cleaning and disinfection process by covering current industry trends, global regulatory expectations, and essential elements needed to keep the cleanroom in a state of continuous control.  The current draft 12 of Annex 1 related to cleaning and disinfection includes RABS cleaning, drain cleaning, pass thru decon, disinfectant rotation, and residue removal which will all be covered.   Cleaning and disinfection are a critical component of a successful contamination control strategy.  There will be an in-depth discussion on current industry regulations.  Sanitizers, disinfectants and sterilant technologies, operator safety, and applications of these products will be discussed.   Videos will be shown to cover the usage and effective application techniques with these products. Current industry trends in disinfectant rotation, biocidal sterility, application techniques, SOP development, and rinsing and residue removal will be discussed.  Regulatory expectations of FDA, MHRA, ANVISA, ANMAT, HPRA, EMA, IFM, and ANSM inspectors will be discussed.  The current draft version 12 of Annex I, USP 43 <1072>, PDA Technical Report #70, IEST-RP-CC-018.5, and other industry related guidance documents will be covered.  The attendees will gain a stronger understanding of current industry trends regarding cleaning and disinfection best practices and how to design an effective risk-based contamination control strategy. Recent industry FDA Warning Letters, FDA 483’s, and case studies will be covered as teaching tools.

Who should attend:

  • Validation Managers
  • Quality Control Managers
  • Quality Assurance Managers
  • Lean Managers
  • Operations Managers
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers
  • Cleaning and Disinfection Manager

Instructor

Jim Polarine (View LinkedIn Profile)

Jim Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years.  His current technical focus is microbial control in cleanrooms and other critical environments. He is a 2019 PDA Michael S. Korczynski Award recipient.  He is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control.  He is active on the PDA’s COVID-19 Task Force and the PDA’s Microbial Excursions Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. He teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee.  He currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is the current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST.  He is also a leader on the PDA’s Chapter Council Steering Committee. His main hobby is storm chasing and is very active in tornado research and tornado safety.

Upcoming Training Date(s):
January 24, 2022
12 - 2 p.m. Central Time
Early-bird discount ends December 3. Use coupon code EB122CLD when checking out to save 10%.
Click here to register online now
Download the print registration form
Pricing:

Regular (through 1/21)

Member Regular: $98
Nonmember Regular: $150

Last Chance (if space is available after 1/21)
Member Last Chance: $123
Nonmember Last Chance: $183

 

Personnel
 
 

This comprehensive module on “Personnel” has been developed to meet the requirements as highlighted in the revision of GMP Annex 1 as part of the  Contamination Control Strategy.

  • Overview of contamination generated or brought in by personnel into the cleanrooms. 
  • Guidance on development of gown choice and management program to ensure integrity of garments and protection of product.
  • Goggle choice and management for controlling personnel borne contamination of open product.
  • Importance of glove choice and gloving procedures as a part of CCS.
  • Gowning procedures, best practices and common mistakes.
  • Training, qualification and disqualification of personnel.
  • Managing and analyzing personnel monitoring data.
  • Using of airflow visualization as a pert of qualification and training of aseptic personnel as required per GMP Annex 1 and current regulatory thinking.

Why you should attend:

This module will provide practical guidance on the requirements for specific training, knowledge and skills as well as qualification of personnel per GMP Annex 1 Draft 2020. There will be specific instructions provided for importance of gown management and examples as well as regulatory observations related to gowning deficiencies that have led to contamination of products will be presented.

Instructor

Ziva Abraham (View LinkedIn Profile)

Ziva Abraham is the President and Founder as well as the Principal Microbiology and Mycology consultant at Microrite, Inc

Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi for her Ph.D degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective. 

Upcoming Training Date(s):

 

Terminal Sterilization Technologies

This module will cover the following:

  • Overview of sterilization
  • Traditional sterilization methods
  • Dry Heat
  • Moist Heat
  • Radiation (Gamma E Beam and X Ray)
  • EO (traditional and SEO)

It will also describe and compare the three Ionizing radiation processes (Gamma, E Beam and X-ray and includes how each is delivered, areas of use, benefits and limitations, availability and guidance in references and standards on validation of sterilization doses to make a claim for terminal product sterilization. 

Defining and comparing Gamma, Electron Beam and X-ray irradiation will be discussed with this additional information:

  • How they are produced
  • Comparison of key function properties
  • Benefits of Ionizing processes
  • Reference and Guidance Standards that apply
  • Dose setting Process for a Sterility Assurance Claim
  • Considerations in deciding to use radiation processes
    • Materials effects
    • Validation time
    • Maintaining a validation with audits

Why and who should attend:

  • Product design and development scientists
  • Quality assurance
  • Microbiology testing and control
  • Product validation specialists
  • Materials selection engineers  
  • Process control and maintenance HealthCare or personal care  products
  • Bioburden reduction uses

Instructor:

Betty Howard (View LinkedIn Profile)

Ms. Howard has been with STERIS AST for nearly 20 years and manages/ provides education and scientific guidance to internal and external Customers on a global scale for all areas of radiation sterilization and related microbiology testing.  She is a member of the industrial committees responsible for developing content and guidance in the industry (ex. AAMI Working Groups for Radiation Processing, Sterility Assurance Levels and Materials Compatibility and BPSA).  Betty has over 30 years industry experience in healthcare, diagnostics and pharmaceuticals product applications including Radiation Sterilization (dose setting, Project Management, problem solving and testing), Biotechnology Research, Applications Development and Technical Support  related to  medical devices, drug discovery, analytic instrumentation, microbiology, biochemistry, sterilization processes and materials compatibility including previous positions with Amersham/GE, Perkin Elmer and Illinois Department of Public Health.  She holds a BS and MS degree from the University of Illinois in Biological Sciences and an MBA in Marketing and General Business.

Upcoming Training Date(s):


 

Ethylene Oxide Sterilization
 

This module will provide an understanding of ethylene oxide (EO) properties, use, and validation of an EO sterilization process.  Relevant parts of the current draft 12 of Annex I will also be covered.   Though often prescribed as a sterilization method of last resort, over half of all single-use medical devices globally are terminally sterilized with EO. This workshop will provide an understanding of: properties that impact the lethality of EO; equipment used to deliver, control, and monitor an EO sterilization process; and proper qualification (i.e., validation) considerations. Relevant industry guidance will also be discussed to provide an understanding of what is required (and recommended) to ensure compliance.

Who should attend:

  • Validation Managers
  • Quality Control Managers
  • Quality Assurance Managers
  • Lean Managers
  • Operations Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers
  • Process, Design, and Packaging Engineers

Instructor:

Ken Gordon (View LinkedIn Profile)

Ken Gordon is a graduate of Florida State University with a Major in Biology and Minors in Math and Chemistry. He has over 20 years of experience in medicine, contamination control, and ethylene oxide sterilization. Ken, a foundational hire to the EO TechTeam, has developed and/or served in virtually every facet of the technical group’s operations. His current role is centered around driving innovation for the EO TechTeam and the EO industry at large, most notably with initiatives such as Sustainable EO® which is refocusing the design and validation of EO processes with an eye toward efficiency and minimizing process impact. The EO TechTeam provides vital internal and external technical support for all matters related to ethylene oxide including (but not limited to): technical consulting, process development/optimization, sterilization validation, white papers, and general research & development. Ken presents at seminars throughout the year and regularly guest lectures for Clemson University. He is a member of STERIS Applied Sterilization Technologies’ global EO Technology Advisory Board and sits on multiple AAMI and ISO working groups.

Upcoming Training Date(s):
 

 

Non-Viable Monitoring
 

Non-viable particle monitoring (AKA Total particulate or particle counting)  based upon light scattering methods, is the principal test method for all cleanrooms, clean air devices, air filters and air quality assessment. International cleanroom standards require this testing as part of the qualification and monitoring of any cleanroom or controlled environment. International cleanroom standards ISO 14644 Parts 1 & 2 provide generic guidance that is applicable to all industries. 

GMP Annex 1 current revision provides additional requirements for non-viable particle monitoring for both classification and monitoring. Non-viable particle monitoring requires a good understanding of particle sizes to be monitored, equipment choice, configurations, use, frequency of monitoring in various cleanroom zones, and interpretation of the data.

This module will discussion the following:

  • Standards and Guidance’s related to non-viable monitoring
  • Continuous monitoring challenges
  • Non-Viable particle counter performance specifications
  • Calibrations Standards for Non-Viable Particle Counters
  • What to look for when choosing equipment
  • Common errors in equipment configuration and use
  • Macro descriptor
  • Monitoring for classification and qualification purposes
  • What does the data tell you

Why you should attend:

Non-viable monitoring is the key test.

Instructor

Morgan Polen (View LinkedIn Profile)

Morgan Polen has been involved with cleanrooms and contamination control since 1984. He has worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, AFV, monitoring program development, particle counter design, and product management for cleanroom related products and systems.  He has addressed monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical, and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards.

Upcoming training date(s):


 

Viable Monitoring
 

This comprehensive module on “Viable Monitoring” has been developed to meet the requirements as highlighted in the revision of GMP Annex 1 as part of the  Contamination Control Strategy.

  • Choice of viable monitoring equipment.
  • Media choice and management.
  • Incubation time and temperature.
  • Setting up alert and action levels.
  • Frequency of monitoring.
  • How to set up risk-based monitoring sites using airflow visualization per Annex 1 requirements.
  • Viable monitoring for performance qualification and routine monitoring.
  • Microbial identification; how and how much.
  • Personnel monitoring.
  • Monitoring of process gases.
  • Development and review of EM trend reports.

Why you should attend:

This module will provide practical guidance on the requirements for viable monitoring including equipment, media incubation, risk based site selection, frequency of monitoring, identification and trending to meet the requirements put forth in EU Annex 1, 2020 Draft.

Instructor

Ziva Abraham (View LinkedIn Profile)

Ziva Abraham is the President and Founder as well as the Principal Microbiology and Mycology consultant at Microrite, Inc

Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi for her Ph.D degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective. 

Upcoming training date(s):


 

Quality Control
 

The quality control (QC) microbiology laboratory plays an essential role in pharmaceutical manufacturing and product release. It is responsible for multiple tasks, including: Environmental monitoring (sampling, bioburden counts, microbial identifications, and tracking and trending of data, and product release tests). Microbiology QC testing of the environment and products provide solutions to reduce microbial contamination, cross-contamination as well as detect contamination in products saving patients from harm.

This 2-hour presentation will emphasize the holistic approach as required by Annex 1 2020 draft. Additionally various microbiology testing methods will be discussed emphasizing common errors made.

FDA 483 observations and case studies will be used to explain the reasons behind testing errors and their impact on product and patient.

Why you should attend:

This session will provide practical guidance on the requirements for specific training, knowledge, and skills as well as qualification of personnel performing quality control testing. It will also discuss common mistakes made in the quality control laboratories that may lead to false negative of false positive results.

Instructor

Jaime Kaho’ohanohano (View LinkedIn profile)

Jaime Kaho’ohanohano has 15 years of direct work experience in quality control testing and microbial contamination control ranging from clinical to commercial facilities. She began her career in the lab and field of collecting and testing of microbial samples. Her attention to detail and inquisitiveness led her to lead high level microbial investigations, trending of data, client audits, risk assessments, and regulatory audit SME. Later in her career as a manager she worked to improve the overall contamination control of a facility that assessed all aspects of microbial risk to the product from gowning, cleaning of materials for entry, to a risk-based Environmental Monitoring program. She now rounds out her career as a Senior Microbiology Consultant for Microrite Inc. She is able to apply her hands-on knowledge and experience to help clients from many different disciplines.

Upcoming training date(s):


 

Production and Specific Technologies: Part 1

Topic will include the following:

  • Aseptic preparation and processing
  • Finishing of sterile products
  • Filter sterilization of products which cannot be sterilized in their final container

Instructor

Details coming soon

Upcoming training date(s):


 

Production and Specific Technologies: Part 2

Topic will include the following:

  • Form-Fill-Seal
  • Blow-Fill-Seal
  • Lyophilization
  • Closed systems
  • Single use systems (SUS)

Instructor

Information coming soon

Upcoming training date(s)