Add an event
Advertise / Referencing
MEDICAL SPECIALTIES > ...

FDA Regulations for Environmental Monitoring Program 2017

From Friday, February, 17, 2017 to Friday, February, 17, 2017 in Fremont
Starting from:10:00
Concerned sectors: Public Health -
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, SECTORS, ACCREDITATION
Accreditations: 0
Concerned Public: General public
Attendance: International
Visitors/Participants: 50
Speakers: 1
Exhibitor: n.c
Event Type: Online Conference
Major Sector: PUBLIC HEALTH
Concerned sectors: Public Health -
ORGANIZER / ADVERTISER

COMPLIANCE4ALL

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

COMMENT
REFERENCE
Congress, conferences or medical training REF #28-7036
FDA Regulations for Environmental Monitoring Program 2017
Published on congres-medical.com on:2016-12-13 16:05:14
Congress, conferences or medical training in PUBLIC HEALTH
Visual / Poster
ONLINE HOTEL BOOKING: Fremont
Get great deals on hotels!
near Online

Search Hotel

Check-in date

Check-out date

VOTE
Rate for this ad
PREPARE YOUR TRIP
Exterior Sponsored Links
This website is certified by Health On the Net Foundation. Click to verify. This site complies with the HONcode standard for trustworthy health information:
verify here.
Plus d'information sur le HONcode