Pharma / Biotech
Upon completion of this course, you will:
This two-day course is designed for all persons who work in, supervise, or are involved in the management of pharmaceutical, biopharmaceutical, and biologics Quality Control laboratories. The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include insuring lab regulatory compliance. This course will also provide participants with an understanding of how to effectively handle out-of-specification results, deviations, laboratory investigations and Corrective and Preventive Actions.
Regulations – Guidance's-Problems
Session 1 – Introduction to Laboratory GMPs
Session 2 – The GMP Laboratory
Session 3-When Things Go Wrong
Session 4-The Regulatory Inspection
Session 5-Laboratory Validation and Other Quality Concerns
Session6-The cost of non-compliance-Hot Topics
This course is intended to give participants a thorough overview and practical understanding of Current Good Manufacturing Practices for laboratory compliance including:
"Dynamic presentation style kept my interest. Practical examples were really useful in making course material relevant. Length of course was good; not too long and not too condensed. Course material was well developed and nicely presented for attendees." Diana B., QC Chemistry Manager, Allergan
"The instructor was extremely energetic and maintained focus of the entire group at all times. Never once did I look at my watch to see how much longer we had to go. He was extremely well versed in all areas and offered appropriate examples to drive home all key concepts." Lauren B., Project Manager, Chiron
"The course was very informative and lots of useful information was presented. The instructor handled a number of difficult questions and I learned a great deal from others in the course." John M., Quality Manager, Berlex
"The material and speaker was great. I liked the examples that he used to convey the material. I appreciated allowing as many students' questions as he did. The recommendation given to read the secondary materials; such as website literature, court cases, and guidance documentation was very helpful. I would look for more classes to take from this course director and company again." Kristi C., Lab Technician
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process.
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If you are registering for others, please set up an Account in the Attendee’s name. If you are
registering more than one person, you’ll need to set up a separate account for each Attendee.
*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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