Establishing a comprehensive microbial control strategy for your company is a key component of contamination control and an expectation of regulatory agencies. This fact is highlighted in the revised version of Annex 1. Contamination control for sterile, non-sterile, low-bioburden and cell and gene therapy manufactured products will all be included in this course with discussions around the differences in each area.
This two-day training course will be a complete review of all aspects of a contamination control program. A review of the regulation and requirements will be performed along with discussions around practical deployment of the requirements as well as challenges and solutions.
This interactive course will provide a detailed review on how to establish and maintain an effective risk based EM Program. Cleanroom classification, HVAC Qualification (EMPQ) and routine environmental monitoring requirements and best practices will be discussed along with establishment of cleaning/disinfection programs and disinfectant efficacy testing. EM alert/action level setting, EM excursion investigations and microbial identifications will be discussed.
Who Should Attend
- Manufacturing - Supervisors/Managers/Specialists
- Quality Control - Managers/Specialists/Technicians/Microbiologists
- Quality Assurance - Managers/Specialists/Technicians/Microbiologists
- Validation - Supervisors/Managers/Specialists/Technicians
- Engineering - Supervisors/Managers/Specialists/Technicians
- Apply current regulatory guidance to your environmental monitoring program and contamination control strategies
- Review and discuss the NEW contamination control requirements in the revised Annex 1
- Understand the requirements of cleanroom classification and ongoing monitoring according to ISO 14644-1,2
- Describe and discuss industry best practice and requirements for establishing cleaning and disinfection programs
- Discuss disinfectant efficacy studies
- Describe how to implement environmental monitoring risk assessments
- Understand differences in EM requirements for non-sterile, low-bioburden, cell and gene therapy and sterile product manufacturing
- Discuss how to create and perform EM performance qualifications (EMPQ)
- Compare and contrast new and existing environmental monitoring equipment
- Explain how to conduct EM investigations
- Describe how to establish EM alert and action levels and how to prepare meaningful trend reports
- Describe and review microbial identification instruments and methods
- Understand how to establish the best microbial control strategy for your company
Marsha Steed , Senior Consultant, ValSource
Marsha Steed has over 25 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha has a Bachelors in Biology from Western New England University in Springfield, MA. She is a Senior Consultant for ValSource and in this role, helps companies implement quality risk management into their quality management systems and validation programs. Marsha specializes in helping companies develop risk based environmental monitoring programs and perform microbial risk assessments. She also provides many training courses and webinars for aseptic processing, cleanroom classification and facility startup. Marsha is an expert in Cell and Gene Therapy. She is active in industry and currently serves on the Parenteral Drug Association (PDA) Science Advisory Board (SAB) and the Education Advisory Board (EAB). She is member of the PDA Task Force on Microbial Investigations, the PDA Microbiology Program Planning Committee and she has been the past chair of the PDA Annual Meeting. Marsha is a former notified body ISO auditor.