Coming into GMP Compliance (C. Orelli).
Documentation Systems (C. Brochard).
Validation (D. Colton).
Quality Assurance (QA) of Production Materials for Biotechnology (D. Miller).
Quality Assurance (QA) of Analytical Methods––Biochemical (F. Bogdansky).
Applied Data Analysis, Sampling Methodologies, and Statistical Validation Techniques (G. Swartz).
Environmental and Safety Programs for Biotechnology (M. Sigourney).
Regulatory Issues––United States (C. Spencer).
Regulatory Issues––Europe (R. Wikberg–Leonardi & D. Mulder).
Regulatory Issues––Japan (R. Rousell & E. Greene).