This course is a part of our Master Class series. Seats are limited.
Cleaning of equipment is an important factor to avoid and reduce the risk of contamination and cross contamination. The cleaning and its validation approach have evolve over time with the implementation of Quality Risk Management principles. Residues of products and excipients as well as of detergents are increasingly an issue in inspections and audits. The success of cleaning validation is based on cleaning principles knowledge, sound rationale, risk assessment and knowledge of the regulatory requirements.
The day of interactive seminar will include:
- Cleaning design and processes.
- Type and selection of cleaners, Soil residue evaluations. Determination of the critical parameter
- Acceptance criteria (based on PDE (Permitted Daily Exposure))
- Equipment grouping
- Product grouping
- Cleaning methods: CIP, manual cleaning
- Design/Commissioning CIP aspects: Coverage test, dismantling
- Sampling selection based on a risk-based assessment, type of sampling (rinse vs swabs)
- Hold time studies: DHT, CHT
- CV execution
- CV Revalidation
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|