A GAMP® Approach to Data Integrity

Plan your June pharmaceutical training now and register to save on interactive training courses led by top pharmaceutical industry experts. Attend the ISPE Training Institute to acquire in-depth education on the topics most important to you and your company.

Sterile Product Manufacturing Facilities (T12) (6 – 7 June)
Review regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, and basic utility systems. European HVAC considerations and a brief introduction to barrier isolation technology are also explained. Exercises in the layout of an aseptic filling facility are included.

Process Validation in Biotechnology Manufacturing (T32)  (13 – 14 June)
Understanding and using USFDA’s Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products. Learn to develop and execute validation master plans and validation protocols that will allow you to successfully run conformance lots for process qualification. Apply strategies and fundamental approaches for process validation of upstream and downstream processes for clinical and commercial manufacturing and discuss validation documentation requirements.

Q7A: Implementing Good Manufacturing Practices (T30) (21 – 22 June)
Biotech and pharmaceutical companies that manufacture APIs face a host of compliance issues unique to their processes. This course reviews and interprets the key GMP requirements specific to bulk biopharmaceuticals and familiarizes participants with the USFDA’s interpretation of ICH Q7, as defined in Q7A.

GMP Auditing for the Pharmaceutical Industry (G07) (27 – 28 June )
Auditors must perform their jobs competently to ensure compliance with USFDA GMP regulations and other quality standards like ICH Q10. This course includes several workshops: audit strategies; potential interview problems; classifying, managing, justifying your findings; and root cause analysis. It also provides numerous report examples and checklists.

View all 2016 pharmaceutical training courses by topic or by location.  Unable to attend these training events? Check out the ISPE eLearning courses.