Like any other Validation studies, Cleaning validation has been considered as a Generic version in the list of Validations. But is that true? We use different Acceptance Criteria for deciding effectiveness of Cleaning. But how can we fix, the correct approach, how should we design & perform the Cleaning validation studies. Are the AGE OLD Concepts, still stand Valid OR else the EXPECTATIONS of the Regulators have changed.
Cleaning Validation is not the baby of QA, but requires integrated efforts of all the functions. Do we feel that we are able to put all the threads together towards performing CV studies. I think - NO. We miss many things, which must be our FOCUS, while designing a Cleaning Validation Protocol. This is the age of RISK, and our Cleaning Validation should be based on the framework of RISKS involved.
Over the period there have been various advancements for evaluating effective cleaning. The current workshop addresses the Cleaning Validation study with a different insight and will definitely make you find that what we had been doing, requires more studies and we can make it a rugged integrated part of the process to ensure Quality, Safety & Efficacy of the Product. The purpose here is NOT to discuss a GENERIC Approach to Cleaning Validation, but to have an in-depth understanding of Cleaning validation and BREAK the thinking process to look it from different Perspective.
Why should you Attend
As a gap in Data leads to critical Data integrity issues, a gap in the effective cleaning procedures raises critical concerns over the integrity of Product quality, safety & efficacy.
The rationale and procedures, the companies are using are left with less reliability. Risk based approach is needed to design a Cleaning validation plan. The session shall cover the Advanced Basics to be considered for carrying out a successful cleaning validation study.
Missing the session will definitely MISS AN OPPORTUNITY to the participants, so as to review Cleaning validation from a different perspective.
Areas Covered in the Session
- Different concepts in Industry for Cleaning validation
- Approaches to derive Acceptance Criteria
- How can we design an effective Cleaning validation plan?
- Regulatory Expectations
Who Will Benefit
- All middle & Senior Management Persons in Pharmaceutical industry
Mr. Vikram Kulshreshta Post Graduate in Microbiology with over 28 years of experience in Quality Assurance & Regulatory Affairs.
Companies worked in - Lupin, Cadila Pharma, Alembic, Amoli Organics, Claris Injectables (Now BAXTER), with Global presence.
Expert in "Designing & implementing the Quality Systems", Qualifications & Validations,Trouble-shooting & CAPA implementation and Regulatory Affairs.
Well versed with International cGMP regulations, e.g. USFDA, MHRA, TGA, ANVISA Brazil, MCC- South Africa, COFFPRIS-Mexico, WHO-Geneva (Prequalification program).
Has Registered many Drug Substances & Drug Product dossiers to US, Europe and other regions. Expert in handling Post DMF Approval changes.
Consultant & Auditor-
API & Formulation manufacturing companies for USFDA/EU Audit preparations, Helped the companies to get USFDA, EU & other Regulatory approvals.
Conducts Pre-inspections Gap analysis & compliance.
Handles USFDA Warning letters to ensure compliance as well as Post audit
observations, to comply with the CGMP, using a holistic & risk based approach.
Conducted Pre-USFDA Gap Analysis and ensured Compliance for Alkem laboratories (for
two Formulation manufacturing sites), Nectar Lifesciences (for their API & Injectable
Formulation manufacturing sites). Both the sites got USFDA approval.
Facility & Projects
Validations & Qualifications - Facility, Equipment, Utilities & Processes
Expert in implementation of Risk based approach in designing Quality Management
Systems, Processes and Validations.
Renovation of existing manufacturing facilities to make it Global Regulatory compliant
(USFDA, EU, MHRA, PICS etc.).
APIs (Sterile & Non sterile), Formulations (Parenterals & Solid/liquid
orals) manufacturing facilities
Quality Management Systems,
Validations & Qualifications
Handling of Regulatory matters
Conducts Trainings as well as Interactive workshops in India and abroad on CGMP,
Validations & Qualifications, ICH (Quality series), Technology Transfer, QMS elements etc.
My Training workshops are attended by the seniors from all the big Pharma companies.
For example in India, the participants are from the companies like – Sanofi, Abbott,Lupin, Aurobindo, Glenmark, Hetero, Torrent, Sun Pharma, Biological Evans, Cadila etc.
Conducts In-house trainings for Employee for up-gradation of knowledge through real life examples using interactive sessions.
Conducts Training Sessions for students in Pharmacy colleges
Delivers session in Pharmexcil INDIA (Export Promotion Council of India).
Webinars in India & Europe on CGMP, Validations & Qualifications, ICH (Quality series), QMS.