active Archives - Page 2 of 2 - Executive Conference Corporation Webinars

Risk Based Approach to Cleaning & Disinfection

Tuesday July 23, 2019
12:00 Noon – 1:30 pm EDT

This seminar will cover the current industry regulations in the US, Europe and Globally related to cleaning and disinfection. Regulatory expectations will be covered including the latest revision of Annex I and recent FDA Warning Letters and 483’s related to cleaning and disinfection will be covered. The current antimicrobial products used in cleanroom industry will be discussed. Cleaning frequency, disinfectant rotation, rinsing and residue removal, disinfectant coverage calculations, and the most current equipment and methodologies for cleaning and discinfection will be covered in detail. The topic of sterility as it relates to cleanroom disinfectants and sporicides will be explained. This seminar will provide the audience with the ability to design and effective risk-based approach to cleaning and disinfection.

Contamination Control Strategies: Facts and Sciences to Consider

Thursday August 22, 2019
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

This webinar will cover a risk-based approach to a cleaning and disinfection program and case studies in contamination control. Details will be provided on how to follow a risk-based approach for cleaning and disinfection using good science. The most common causes of contamination will be conveyed in case studies with fungal spore, bacterial spore, and Deinococcuscontamination. Solutions will be discussed on how to proactively prevent contamination from reoccurring.

Best Practices for Cleaning Validation Swab Sampling and Recovery Studies

Thursday September 19, 2019
12:00 Noon – 1:30 pm EDT

Instructor: Richard Forsyth

This Web Seminar will present a detailed overview of best practices for cleaning validation swab recovery and sampling for Active Pharmaceutical Ingredients (APIs) and detergents from product contact surfaces of equipment in the pharmaceutical industry. All aspects of swab sampling will be discussed with the emphasis on how swab sampling ties into the cleaning validation program.

Current regulatory expectations and how they impact swab recovery and sampling will be reviewed. Of note will be the expectations for acceptable recovery studies and concerns for instances of low recoveries.

The swab parameter phase evaluates the parameters necessary to clearly demonstrate that a swab sampling will accurately and consistently provide data that demonstrates a cleaning validation study is successful. The swab parameters are evaluated individually to assess their impact on swab data. The calculated cleaning limit directly impacts the swab parameters to be validated.

Best Practices for Cleaning Validation Swab Sampling and Recovery Studies

Wednesday March 20, 2019
12:00 Noon – 1:30 pm EDT

Instructor: Richard Forsyth

Cleaning and Cleaning Validation

Tuesday October 22, 2019
12:00 Noon – 1:30 pm EST

Instructor: Richard Forsyth

This Web Seminar will present a comprehensive overview of the life-cycle approach to cleaning for product contact surfaces of equipment in the pharmaceutical industry. The four phases of cleaning : cleaning assessment, cleaning development, cleaning validation and cleaning monitoring will be discussed including how they contribute to a compliant, evolving cleaning program.

The cleaning assessment phase evaluates either the current cleaning procedure or a proposed change to the current cleaning procedure against the current regulatory cleaning validation expectations. Any necessary remediation strategy for the assessment is determined in order to define an efficient cleaning development study.

Grouping Products and Equipment for Cleaning Validation and Selection of Worst-Case Parameters for Efficient Cleaning Validation Execution

Wednesday November 6, 2019
12:00 Noon – 1:30 pm EST

Instructor: Richard Forsyth

This Web Seminar will present a comprehensive overview of the product grouping and equipment grouping for cleaning validation (CV) for product contact surfaces of equipment in the pharmaceutical industry. Grouping of products and equipment are necessary in a multi-product facility to develop a comprehensive, understandable, executable and maintainable cleaning validation program.

Product grouping is used to identify the product(s) for CV execution. The selection criteria are critical to justify a defendable product grouping. Although a number of criteria are available, the two recommended criteria to use are: hardest-to-clean product and the product with the lowest cleaning limit.

The hardest-to-clean criterion is based on the physical properties of the formulation components and the proportion of each component in the formulation. In an aqueous or detergent based cleaning medium, hydrophilic, water soluble components are relatively easy to clean, whereas hydrophobic formulation components are more difficult to clean.

Debates and Challenges Concerning Disinfectant Validation and Methods to Circumvent Them

Wednesday November 13, 2019
12:00 Noon – 1:00 pm EST

Instructor: Jim Polarine

This presentation covers current debates in the industry regarding disinfectant coupon testing. PDA Technical Report No. 70 and USP 39 <1072> will be covered in relation to current industry disinfectant efficacy testing. Recent FDA Warning Letters and 483s will be covered that highlight regulator expectations in disinfectant efficacy testing. Data will be presented covering the importance of disinfectant efficacy testing with specific bacterial spores which can be more difficult to kill than ATCC strains. Both sides of the debate on disinfectant validation will be covered in detail with an emphasis on current FDA, MHRA, ANVISA, and HPRA regulatory expectations and reducing the costs for testing.