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SPECIALITES MEDICALES ...

FDA Regulations for Environmental Monitoring Program 2017

Du Vendredi 17 Février 2017 au Vendredi 17 Février 2017 à Fremont
A partir de: 10:00
Secteurs concernés: Santé publique -
DESCRIPTION
Overview: 
Upon completion of this training, you will be able to Describe how Clean

room Environmental Monitoring (EM) Program fits into the Regulations.

Explain the basis of the Four (4) Phases of Clean room transitional

monitoring (Pre-qualification through post-qualification EM) and what

each type stands for. List the basic content of a well-designed, effective

and compliant EM Program. Explain the relationship between an EM

Excursion Program and CAPA

Why Should You Attend:
The cost of non-compliance is therefore more than that of compliance.

Are you in compliance with the FDA regulations for Cleaning Validations

of your manufacturing equipment?

Areas Covered in the Session:
Applicable Regulations - Where does the EM Program fit in the

Regulation? - Role of Clean room Environmental Monitoring Program?
Basics of Setting a Robust and Effective EM Program - Key

Considerations - Relevant Material Verification Processes - Steps and

Content of an EM Program Testing Procedure

Who Will Benefit:
Quality Control,
Quality Assurance
Microbiologist, Facilities
Chemist, Analysts
Manufacturing
Validation
Engineering

Speaker Profile:
Joy McElroy Upon earning a degree in Zoology at North Carolina State

University, Joy made her debut in the pharmaceutical industry in 1992 at

Pharmacia & UpJohn performing Environmental Monitoring and Sterility

Testing. Her hard work allowed her to move into a supervisory role at

Abbott Laboratories where she oversaw their Quality Control Lab. In

1998 Joy moved to Wyeth Lederle and worked in Quality Assurance,

performing GMP Compliance audits, batch record reviews, and holding

annual GMP training for new employees. After working in Quality

Assurance for a few years, Joy moved into Equipment Qualification and

Cleaning Validation at Mallinckrodt.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

PUBLIC, SECTEURS, ACCREDITATION
Accréditations : 0
Public concerné: Grand Public
Audience: Internationnale
Visiteurs/Participants: 50
Conférenciers: 1
Exposants: n.r
Type d'événement: Conférences en ligne
Secteur principal: SANTE PUBLIQUE
Secteurs concernés: Santé publique -
ORGANISATEUR / ANNONCEUR

COMPLIANCE4ALL
161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congrès, formations ou conférences médicales REF #28-7036
FDA Regulations for Environmental Monitoring Program 2017
Publié sur congres-medical.com le : 2016-12-13 16:05:14
Congrès, formations ou conférences médicales en SANTE PUBLIQUE
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