This course is a part of our Master Class series. Seats are limited.
This one-day process validation training session is designed to provide an overview of the latest concepts in Process Validation. The US FDA and EMA have different approaches to Process Validation, understanding these approaches will provide the best opportunity to develop and implement compliant validation approaches, and manufacture or deliver safe products.
The day of interactive seminar will include:
- PV concepts
- CPP (Critical Process Parameters) and CQA (Critical Quality Attributes)
- Life cycle approach to Process Validation
- Acceptance criteria
- Number of batches
- Sampling plans
- Impact of intermediate storage
Speaker: Mrs Julie-Léa Lipszyc, Principal, Quality & Compliance
Mrs Julie-Léa Lipszyc has over 22 years of experience in the pharmaceutical and biotechnology sectors. Julie-Lea has a diploma in BioPhysics and a Master’s Degree in Sciences and Technology in Quality Assurance of pharmaceutical, cosmetic and dietetic products from the Pharmacy University of Paris XI. She has managed and participated in projects related to the pharmaceutical, biotech and medical devices sectors for which she performed compliance design reviews, developed complete quality systems, developed cleaning and microbiological method validation protocols, carried out regulatory affairs and supported clients during regulatory inspections. She has also supervised multiple quality assurance teams. Julie-Lea is also very involved in Quality Risk Assessment and has performed multiple quality, cross-contamination and mix-ups risk assessments. She also provided training on Validation, Risk Assessment, Lean Quality Systems, in North America, Europe and South Korea. Within the scope of Canadian, US and European compliance regulations, her fields of expertise include: Active Pharmaceutical Ingredients (APIs), drugs, blood and tissue products, biotech (vaccines), sterile products, high potency compounds, laboratories, clinical trials, medical devices, natural health products.
|Basic Member Ticket:||$795.00||— Sold Out|
|Pro/Pro Plus Member Ticket:||$745.00||— Sold Out|