sterilizationconsulting.com

Sterilization Consulting Services - Ensuring regulatory compliance in a competitive market

Sterilization consulting services: experienced consulting in the sterilization and manufacturing of medical devices. Expertise: radiation, EO and steam sterilization, developed and validated sterilization cycles and procedures, management of microbiologocal laboratories, built and validated various sterilization systems, quality assurance with medical device manufacturing, quality and microbiological audits within various manufacturing environments

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Sterilization Consulting Services - Ensuring regulatory compliance in a competitive market | sterilizationconsulting.com Reviews

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Sterilization consulting services: experienced consulting in the sterilization and manufacturing of medical devices. Expertise: radiation, EO and steam sterilization, developed and validated sterilization cycles and procedures, management of microbiologocal laboratories, built and validated various sterilization systems, quality assurance with medical device manufacturing, quality and microbiological audits within various manufacturing environments

<META> KEYWORDS

1 sterilization consulting services

2 sterilization

3 microbiology

4 ra/qa

5 packaging

6 qualifications

7 sterilization validation

8 medical device microbiology

9 applicable standards

10 connect

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sterilization consulting services,sterilization,microbiology,ra/qa,packaging,qualifications,sterilization validation,medical device microbiology,applicable standards,connect,harry shaffer,hshaffer@sterilizationconsulting com

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Sterilization Consulting Services - Ensuring regulatory compliance in a competitive market | sterilizationconsulting.com Reviews

https://sterilizationconsulting.com

Sterilization consulting services: experienced consulting in the sterilization and manufacturing of medical devices. Expertise: radiation, EO and steam sterilization, developed and validated sterilization cycles and procedures, management of microbiologocal laboratories, built and validated various sterilization systems, quality assurance with medical device manufacturing, quality and microbiological audits within various manufacturing environments

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sterilizationconsulting.com

1

RA/QA

http://www.sterilizationconsulting.com/raqa

Ensuring regulatory compliance in a competitive market. FDA and CE mark gap analysis, including pre-FDA auditing. Internal and Supplier auditing. Responses to FDA 483s and Warning letters. Assistance in System development or improvements. Evaluation and/or Development of Business Strategies. AAMI/ISO standards detail the requirements and guidance used throughout the industry. These standards are consensus voluntary standards which are the minimum requirements for the manufacturing and sterilization o...

2

Applicable Standards

http://www.sterilizationconsulting.com/applicable-standards

Ensuring regulatory compliance in a competitive market. AAMI/ISO standards detail the requirements and guidance used throughout the industry. These standards are consensus voluntary standards which are the minimum requirements for the manufacturing and sterilization of Medical Products. With a combination of these standards and the years of experience, Sterilization Consulting Services can provide solutions for all of sterilization needs. Contract sterilization using ethylene oxide. Sterilization of heal...

3

Packaging- Sterilization Consulting Services

http://www.sterilizationconsulting.com/packaging

Ensuring regulatory compliance in a competitive market. Harry Shaffer, Sterilization Consulting Services, has extensive experience in the development and validation of industrial sterilization packaging systems. He has assisted numerous clients to develop and validate their sterile packaging systems in accordance with the AAMI/ISO 14607 series of standards. He will work with contract laboratories to insure that the testing performed meets and exceeds the AAMI/ISO requirements. 10051 Oak Leaf Way.

4

sterilization validation

http://www.sterilizationconsulting.com/sterilization

Ensuring regulatory compliance in a competitive market. Preparation of validation protocols. Managing the execution of the protocols. Review of the data to insure compliance with AAMI/ISO guidelines. Writing of the Final report(s). Implementation of the Sterilization Release process, including the necessary Procedures for cycle review. Developing the Procedures for Sterilization deviations and product adoptions. Establishment of Sterilization Processing Categories. Determination of EO residuals. AAMI/ISO...

5

Regulatory compliance qualifications

http://www.sterilizationconsulting.com/qualifications

Ensuring regulatory compliance in a competitive market. Ensuring regulatory compliance in a competitive market. Abilene Christian University, Abilene, TX B.S. Biology 1978. Abilene Christian University, Abilene, TX M.S. Microbiology 1980. 1994 2002 Vice President/General Manager, Titan Scan Technologies, San Diego, CA. 1984 1994 Director of Quality Assurance/Sterility Assurance, Baxter Healthcare, El Paso, TX. 1980 1984 Sterility Assurance Supervisor, Ethicon, Inc., San Angelo, TX. Sterilization and Pres...

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Ensuring regulatory compliance in a competitive market. Ensuring regulatory compliance in a competitive market. Experience: Harry Shaffer has over 33 years experience in the sterilization and manufacturing of medical devices. In addition to expertise with radiation, EO and steam sterilization, Harry has also developed … Read More. Harry Shaffer, Sterilization Consulting Services, is a leader in the development of the sterilization standards and sterilization validation for the … Read More. AAMI/ISO stand...

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