ComplianceOnline

Course Description:

Cleaning is of vital importance to the product safety in the pharmaceutical manufacturing. This training program will cover the key GMP requirements for cleaning validation, the methods of cleaning, effective cleaning procedures, developing effective cleaning procedures, approaches to cleaning validation based on scientific rationale, different analytical techniques, and risk assessment in the cleaning validation. This course provides a detailed and structured introduction to cleaning validation, as well as details of current best practice, cGMP expectations, industry trends and regulatory issues for both the EU and US markets. Therefore, it is suitable for both new and experienced professionals in this field. This course will help the attendees with a better understanding of regulatory requirements and technique.

Analytical methods used to test products should have quality attributes built into them, and analytical method validation is used to both demonstrate that the method is fitted for its purpose and to meet the regulatory requirements. This training course gives a review and strategy for the validation of analytical methods. It will provide both theoretical understanding and practical knowledge of the method validation progress. The regulatory requirements on method validation and their implications in the pharmaceutical industry will also be discussed. This presentation can guide managers and analysts through all aspects of analytical methods validation. The difficulties encountered in carrying out method validation will be covered. This course also addresses the setting up of acceptance criteria and the application of method validation in herbal medicines. Strategies and recommendations for the validation of internally developed methods and verification of compendial methods will also be given.



Learning Objective:

  • State the GMP reasons for cleaning validation
  • Interpret regulatory requirements and guidelines
  • Outline a strategy for cleaning validation that complies with cGMPs
  • Apply risk management principles to identify cleaning validation parameters
  • Cleaning process variability & controls
  • Develop practical limits for cleaning residues
  • Risk based approach to grouping strategy
  • Develop a basic cleaning validation protocol
  • State the requirements for laboratories in support of cleaning validation studies
  • Parameters required for analytical method validation
  • Discussion of acceptance criteria for method validation parameters
  • Regulatory requirements for analytical method validation
  • Requirements for inter-laboratory method transfer
  • Requirements for verification of compendial and other official methods
  • Setting up acceptance criteria
  • Method validation: a life cycle process
  • Method validation for herbal medicines
  • Allowed method adjustments
  • Practical problems encountered in the method validation

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar



Who will Benefit:

  • Quality assurance
  • Quality control
  • Validation
  • Manufacturing
  • Process engineering
  • Laboratories
  • Regulatory affairs
  • R & D
  • Technical affairs




Course Outline:

DAY ONE (8:30 AM – 4:30 PM) DAY TWO (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM

Session Start Time: 9:00 AM

Cleaning validation in the pharmaceutical process

  • 8.30 am – 10.15 am:
    • Why to perform cleaning validation
    • What is cleaning validation
  • 10.15 am – 10.25 am:
    • Tea break
  • 10.25 am – 12.00 pm:
    • How to perform cleaning validation: part 1: overall description
    • How to perform cleaning validation: part 2: details
  • 12.00 pm - 1.00 pm:
    • Lunch
  • 1.00 pm - 2.45 pm:
    • When to perform cleaning validation and revalidation
    • Risk management in cleaning validation
  • 2.45 pm - 4.30 pm:
    • Case studies

Analytical method validation in the pharmaceutical industry

  • 8.30 am – 10.15 am:
    • Parameters required for analytical method validation
    • Discussion of acceptance criteria for method validation parameters
    • Regulatory requirements for analytical method validation
  • 10.15 am – 10.25 am:
    • Tea break
  • 10.25 am – 12.00 pm:
    • Requirements for inter-laboratory method transfer
    • Requirements for verification of compendial and other official methods
    • Setting up acceptance criteria
  • 12.00 pm - 1.00 pm:
    • Lunch
  • 1.00 pm - 2.45 pm:
    • Method validation: a life cycle process
    • Method validation for herbal medicines
    • Allowed method adjustments
    • Practical problems encountered in the method validation
  • 2.45 pm - 4.30 pm:
    • Case studies




Meet Your Instructor

Amer Alghabban
Vice President GxP Quality Assurance, Compliance Training, Karyopharm Therapeutics Inc.

Amer has over 26 years track record in the pharmaceutical industry (GxP QA, GCP, GVP, GCLP, GLP & GMP). He has presented & chaired at over 85 international Congresses, Universities & WHO. He was Assistant Editor for 11 Medical & Pharmaceutical journals and Sole author for 2 books “The Pharmaceutical Medicine Dictionary” in Apr01, “The Dictionary of Pharmacovigilance” May04 & currently writing 3rd book, "Dictionary of Clinical & Pharmaceutical Development".

He has a track record in GxP QA and experience of working at a RA (MHRA). He has managed & hosted over 66 Regulatory Authority (RA) inspections & inspection readiness projects. He has over 16 years GxP auditing experience of clinical services providers (CROs, Pharmacovigilance), Business Partners/Due Diligence, Investigator Sites, Clinical Central (& specialist labs e.g. Biomarkers) Labs (GCLP), Vendors (ECG, MRI, DM, etc), EC/IRBs, Mock Inspections, Essential Documents (Protocol & Amendments, ICF, CSR/CTR, Submission Dossier, etc), Clinical & Safety Database Audits, PhV System/ Process/ Vendors, Pharma Company Affiliates, HQ operations, GMP sites, GLP Test Facilities compliance with applicable regulations.







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