AKA is a network of recognized industry leaders headed by Dr. Akers and Ms. Kennedy. The primary objective of AKA is to provide technical consulting services to the biological/pharmaceutical industry worldwide in the areas of validation, regulatory compliance, quality assurance and project management. AKA targets difficult validation problems and new technology concerns and issues.
The AKA team has authored numerous articles, chapters and publications on a variety of topics including aseptic processing, environmental monitoring, isolation technology, sterilization, biotechnology, validation management and change control. Dr. Akers participates in training for the pharmaceutical industry, trade organizations, private companies and regulatory agencies. He has conducted training sessions for FDA on sterilization, aseptic processing, and isolation technology. Dr. Akers has presented lectures and led round table discussions for a number of international and domestic associations.
Since the beginning, clients around the world have benefited from GMP reviews and evaluations, protocol writing, technical assistance on validation policies and procedures, and training performed by AKA.
Environmental Monitoring Investigations
In our continuing effort to address “hot topics” in manufacturing and process control we’d like to call our visitor’s attention to a short communication on Environmental Monitoring Investigations posted today in our articles section. We are finding that a number of firms are concerned about the number of investigations they are doing into low-level environmental contamination in aseptic processing. We hope our article is interesting to you and we invite your comments.