Cleaning Validation Modern Techniques, Application and Controls – Hybrid Workshop

HYDERABAD | SEPTEMBER 24, 2021 | 10 AM to 5 PM India Time
This is a Hybrid Workshop. The seminar will be physically conducted in Hyderabad and simultaneously Live Streamed to delegates attending Virtually.


For 1 Attendee:   Rs. 12000*   Add to Cart

For 5 Attendees: Rs. 48000*   Add to Cart

*Prices mentioned are exclusive of GST (18%).
If you have a bigger group, please contact us at 080-4170-0521 or


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About SeminarWho Should AttendAgendaSpeakerVenueT&C
This interactive training course utilizes the: Product and process Realization using current cGMP requirements, Concepts and Principles of – Product and process Realization using Quality by Design, Risk based approach with Illustrative Example as the basis for explaining and providing examples of how products and processes can be validated, using QRM with special emphasis on the considerations for implementing these processes in manufacturing with respect to Formulation and API.

Through group discussions, the course will delve into implementation and operation of an effective and efficient control validation strategy in manufacturing which is a key element of process performance and product quality monitoring and continual improvement in Process validation. The link to control of attributes and parameters to relevant critical quality attributes of the product and application and implementation of enhanced, QRM approaches with respect to Process development, Design space, control space and Process validation, Qualification of process and analytical equipment and facility validation will be explored.

Recently A new Guideline from EMA on Dedicated Facilities and Exposure Limits for Cleaning Validation and the revised Annex 15 now deal with a PDE (Permitted Daily Exposure) approach and APICs published cleaning validation residue MSC and MSSR approach as per Recent WHO TRS guideline.

The interest of this training and the topics it intends to concentrate on are:
– Cleaning validation and its Principles and conduct of cleaning validation
– Modern cleaning techniques of Equipment’s; Analytical instruments and facility

– Finished Pharmaceuticals
– API Manufacturers
– Formulation Companies
– Analytical Development Laboratories
– Contract Research Organizations
– Contract Manufacturing Organization laboratories
– Quality Assurance Departments
– Quality Control Departments
– Research and Development Departments
– Regulatory Affairs Departments
– Engineering Departments
– Manufacturing Departments
– Operations Departments
– Production Departments
– Validation Teams
– Technology Transfer Professionals
– Documentation Teams
– Professionals taking care of Process validation
– Cleaning validation and qualification activities of equipment and instrument facility
– Auditors (internal and external) responsible for assessing
– Those planning to engage in the export market and who wish to achieve cGMP compliance would also benefit from this workshop

Cleaning Validation Concepts
– Principles and Concepts

Conduct of cleaning validation
– How to do Residue calculation MSC and MSSR based on WHO TRS /PIC(s) requirement
– CV Risk Management
– CV Plan-Cleaning validation protocol
– CV Report-cleaning validation report
– CV Revalidation, CV Verification

Typical inspection findings, warning letters

Special Aspects of Cleaning Validation Acceptance criteria
– Cleaning methods: CIP, WIP, manual cleaning

Controls and monitoring of CV
– Random Controls and Hold time studies: DHT, CHT
– Validation of analytical methods used for CV

Designing cleaning validation SOP
– Cleaning Procedure and SOP
– Discussion about sampling
– Discussion about how to do Cleaning Sop-Day out cleaning
– Dry cleaning (batch to batch) and wet cleaning (Product change over ;longest unused storage)

ISPE Cleaning validation guide
– Discussion on ISPE cleaning validation guide in detail wrt cleaning validation Life cycle; Methods and controls

Group discussion and case study on cleaning validation

Certification and Closing

G. Sundar

Director-Consultant at PharmQA Compliance


G. Sundar is a quality practitioner with vast experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA, Japan guidelines.

He has conducted more than 50 GMP/GLP audits including Q10 & Q11 implementation, 50 Formulation Contract Manufacturing Units (all types of formulations,), 10 Contract Research and Analytical laboratories, 4 Clinical research CROs. He has also conducted 100 plus trainings all over India, Asia and Europe.

Mr. Sundar Ganesan is currently working as Director-Consultant at PharmQA Compliance services an independent consultant.

September 24, 2021

Hyderabad, TS, India

Venue to be announced soon

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Written cancellations through email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund – minus a 20% administration fee. No cancellations will be accepted – nor refunds issued – within 10 calendar days before the start date of the event.

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