Environmental Control and Monitoring for Regulatory Compliance
Registration Options
Individual Registration
Group Registration
Time: 8:30 a.m. - 4:00 p.m.
Environmental monitoring and control continues to be a regulatory focus with numerous 483s having been issued to firms facing difficulties managing this critical quality systems component. By understanding both the regulatory and quality issues in environmental monitoring, companies can be assured in the quality of their finished products.
This comprehensive class will discuss facility design and validation, including personnel flow, equipment flow, baseline monitoring, media fills and quality control. The tracking and trending of the data will be reviewed, and a focus will be on the “best industry practices” to employ when performing environmental monitoring. FDA and international standards related to microbiological issues will be covered, with an emphasis on how to avoid quality problems. Finally, a case study will be presented to demonstrate the most effective and efficient methods to use when performing environmental investigations.
Who Should Attend
This course will be beneficial for environmental monitoring technicians, engineers involved in aseptic design and validation, and personnel in QA/QC, sterility testing, manufacturing, aseptic operations, validation and training.
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Day 1
Upon completion of this course, you will be able to:
- Summarize global regulatory requirements for environmental monitoring (EM)
- Recognize the various EM guidance documents
- Explain the various approaches to tracking and trending EM data
- Evaluate automation systems used for EM
- Discuss key validation issues with EM
- List the benefits and use of risk analysis for EM
Continuing Education for Pharmacists
PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:
PDA #341 | ACPE #0116-0000-16-019-L04-P | 0.6 CEUs
Type of Activity: Knowledge
Continuing Education for Professional Engineers
New Jersey
PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.
The credit value of this course is 6 CPC credits.
North Carolina
PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.
The credit value of this course is 6 PDHs.
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PDA Training and Research Institute
4350 East West HighwayBethesda, MD , United States
Frank S. Kohn, PhD, President, FSK Associates