Dates: December 7th - 8th, 2017

Location: HYDERABAD, India

Venue: Hotel Mercure KCP, Hyderabad

Presenter: Dr. G.K.B. Prasad
(ex- US FDA Laboratory Scientist)

Download Your Brochure & Registration Form

DESCRIPTION

The two day workshop on Pharmaceutical Validation - Latest Global Regulations and Trends to Stay Compliant, is designed to provide an in-depth understanding of the concept of pharmaceutical validations based on the current FDA, EU and ICH guidance documents as well as learnings from the pharmaceutical industry. Special emphasis will be laid on practical approach and simple illustrative examples from the industry for judicious and effective implementation.

A successful validation program depends on proper planning & execution through protocols. Preparation of a 'Validation Master Plan' and 'Validation Protocol' as well as types of records required to demonstrate successful validation will also be presented. This program will cover issues specific to both APIs and Oral Solid Dosage forms and is designed to focus on implementation in work place.

This approach is expected to bring in an element of robustness into the manufacturing process and quality system. Risk management and statistical tools are being used in leading pharmaceutical industry worldwide and is recommended by regulatory agencies in order to gain high level of confidence in the quality of drugs as well as to achieve continuous improvement.

The participants will be exposed to the latest concepts and thinking of international regulatory agencies on validation of manufacturing process, analytical as well as cleaning methods applicable in API & Oral Solid Dosage forms manufacturing. based on assessed risk. The workshop will also include typical examples from the industry and the participants will be able to execute validations in a judicious manner.  .

LEARNING OBJECTIVES

  • FDA, ICH and EU Regulations
  • Process Validation
  • Validation Master Plan
  • Equipment Qualification
  • Risk Management Tools and Techniques
  • Process Design and Development
  • Technology Transfer
  • Continuous Process Verification
  • Analytical Method Validation
  • Cleaning Validation
  • SOPs and Best Practices
  • CASE STUDIES .... and More

WHO MUST ATTEND

A must attend seminar for professionals in Pharmaceuticals, QC Laboratories, Manufacturers of drug substances (APIs), Oral Solid Dosage Form, Contract Laboratories, and Biopharma companies.

DEPARTMENTS:

- Quality Control
- Quality Assurance
- Research and Development
- Manufacturing
- Regulatory Compliance
- Validation
- Production
- Technology Transfer
- Laboratory
- Documentation
- Training Departments

PROFESSIONALS:

- Managers
- Supervisors
- Senior Managers
- Team Leaders
- Executives and Senior Executives
- General Managers
- Engineers
- Design Engineers
- Plant Managers
- Laboratory Managers and Supervisors
- Regulatory Affairs Managers
- Documentation Specialists & Analysts

SEMINAR AGENDA

DAY 1

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM (Welcome and Introduction)

Regulatory Requirements and Expectations
- US FDA and the EU Draft Guidance
- ICH Guidelines
- Regulatory Expectations

Management of Documents and Qualification
- Validation Policy
- Validation Master Plan (VMP)
- Documents Equipment Qualification
- Effective SOPs
- Qualification Phases, IQ, OQ, PQ, DQ
- Qualification vs. Validation

Process Validation
- Understanding Process Validation
- Process Designing
- Developing a Control Strategy
- Quality Life Cycles Approach Concept
- Common Mistakes in Process Validation

Risk Management Tools and Techniques
- Risk-Based Approach for Pharmaceutical Validation
- Practical Risk Management Tools and Techniques
- Critical Issues and How to Overcome Them

Approaches to Process Design
- Process Development
- How to use Quality by Design (QbD) strategies to your advantage
- Technology Transfer Methodolgy
- Traditional and Design Space Approaches
- Regulatory Expectations
- Facility Qualification - ASTM E 2500

Q&A Session
Networking and Close: 5.30 PM – 6 PM

DAY 2

.
Session Start Time: 9:00 AM

Process Qualification & Continuous Process Verification
- Understanding the Differences
- Effective Continuous Monitoring
- Strategies and tools to execute the 2nd and 3rd stages of Process Validation
- Validation Strategies proposed by European Regulatory Agencies

Analytical Method Validation
- Scope and content of the guidance
- Validation parameters, tests, and acceptance criteria
- Lifecycle management of analytical procedures
- Periodic review and revalidation
- Analytical method transfer studies
- Documentation requirements, SOPs and Report Writing
- Verification of submitted methods at the FDA
- Chromatographic method

Cleaning Validation
- Development of cleaning procedures
- Preventing Product Contamination
- Critical Cleaning Procedures based on risk levels
- Types of cleaning options
- A risk based approach to Cleaning Validation
- Strategy for the validation of cleaning methods
- Calculation of Cleaning Limits
- Sampling and detection methods
- Effective Execution of cleaning validation
- Development of cleaning protocols

CASE STUDIES
- Review of FDA warning letters
- Learning from Various Industry Examples

Final Q&A Session
Certification, Networking and Close: 6 PM – 6.30 PM

PRICING & REGISTRATION

Limited Seats Available with Discounts

HOW TO REGISTER, AND TERMS & CONDITIONS

VENUE DETAILS

  • Address
    Hotel Mercure KCP
Hyderabad, India

Venue:
Hotel Mercure KCP
Banjara Hills Main Rd, Somajiguda,
Hyderabad - 500082, Telangana

PARTNER WITH COMPLIANCE TRAININGS

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