2-Day Workshop on Cleaning Validation – Modern Methods, Application and Controls

Presenter:
G. Sundar
APRIL 22 – 23, 2021
HYDERABAD, TS
APRIL 26 – 27, 2021
BANGALORE, KA
9 AM to 5 PM
India Time
Case Studies and Certification
Download Brochure & AgendaDescriptionWho Should AttendSpeakerVenueT&C
Why Should You Attend:

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.

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

Key Learning Objectives:

– Cleaning Validation Concepts
– Introduction of relevant Guidelines
– CV Concepts and how to do residue and MACO calculation
– Cleaning validation as per current MSC and MSSR approach based HBEL limit.
– 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
– Random Controls and Hold time studies: DHT, CHT
– Validation of analytical methods used for CV

Substantial business benefits are emerging from industry when GMP validation and qualification principles are used for new and existing drug products yielding reduced operating costs, enabling significantly more efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations.

In the manufacture of medicinal dosage products and APIs, the cleaning of facilities and equipment is an important measure to avoid contamination and cross contamination. In compliance with the GMP regulations, cleaning is performed and documented according to the described procedures. In the past, cleaning effectiveness was often monitored only visually. However, residuals of APIs and excipients as well as of detergents are increasingly an issue in inspections and audits. The success of cleaning procedures has to be validated. In addition to the FDA “Guide to Inspection of Cleaning Validation”, the PIC/S document PI 006 and revised Annex 15 address cleaning validation in a separate chapter. Moreover, the ICH Guideline Q7 “GMP for APIs” also requires cleaning validation – as well as two guidelines by APIC, the association of European API manufacturers.

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 MACO(MSR) calculation by PDE (Permissible Daily Exposure Limit) and VDI approach.

– 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

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.

April 22 – 23, 2021

Hyderabad, TS, India

Venue to be announced soon

April 26 – 27, 2021

Bangalore, KA, India

Venue to be announced soon

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at info@compliancetrainings.in

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Email: info@compliancetrainings.in

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