Lecture series on Good Clinical Laboratory Practice (GCLP)

Good Clinical Laboratory Practice (GCLP) is a set of standards that provide guidance on implementing Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) principles to the analysis of samples from a clinical trial. By combining the GLP and GCP sets of guidelines, GCLP ensures the reliability, quality, consistency, and integrity of the clinical trial data generated by laboratories. Compliance with this standard provides assurance that the data and reported results are credible and accurate and that the rights, safety, and confidentiality of trial subjects are protected.

Day 1

• Overview of Good Clinical Laboratory Practice
• GLP, GCLP, GCP
• Laboratory Quality Management System
• Various GCLP guidelines
• Roles and responsibilities; Organization and personnel
• Equipment, materials, and reagents, subcontracting of work
• Guidelines for laboratory facilities
• Open forum for question and answers

Exercises:

• Role play
• Case studies
• Quiz (semi-final)

Day 2

• Document control, SOP
• QC, QA, IQC, EQUAS
• Method validation
• Ethical consideration
• Data Management, LIMS
• Reporting of results, accreditation
• Open forum for question and answers

Exercises:

• Group work and presentations
• Individual exercises
• Quiz (Final).

During this programme, participants shall learn about:

1. Various GCLP guidelines.
2. What are GLP, GCLP, GCP and their scope?
3. All aspects of clinical trial laboratory operations as per the GCLP standards.

At the end of this programme, the participants shall be able to:

1. Describe the differences between GLP, GCLP, GCP.
2. Understand the principles of GCLP and the requirements of each principle.
3. Identify the steps to be followed.
4. Apply and implement the GCLP guidelines in a laboratory.

• Interested personnel from the industry, research institutions, hospitals, clinical laboratories, academic institutions, government bodies, etc. with minimum academic qualification of (BSc/MSc/PhD/BPharm/MPharm/ BAMS/BHMS/BDS/MDS/MBBS/MD/DM) and at least 2 years of work experience are eligible to apply for the programme.
• There is no age limit to apply for the programme.
• Interested personnel working in diagnostic/clinical laboratories, engaged in clinical research and engaged in research and development activities in similar areas may be well-suited to apply for the programme.
• Limited seats shall be available for non-working professionals who have completed their post-graduate/doctorate degree in areas of science and technology and seeking employment.
• Only those applicants with relevant background and expertise in the area of training are encouraged to apply for the programme.

In order to apply for the programme, please click on the ‘Apply Now’ button. Application form comprises of questions related to participant profile, academic qualifications, work experience, achievements, etc. As part of the application, following is required to be submitted along with the application –

1. Date of birth proof ID (Driver’s License, Aadhar, PAN Card, Passport)
2. Endorsement Letter from head of department/organization (For working professionals)
3. Certificate of highest academic qualification
4. Screenshot of online payment

In case of inability to upload document along with the application form, please check the size of the document. The permissible limit of each document is 1 MB.

A nominal amount of refundable commitment fee of Rs. 1,500/- shall be charged from applicants to ensure only serious candidates applies for this programme. The fees need to be paid as part of the application form using a safe and secure integrated payment gateway. Please mention your bank account details in the application form in order to refund the fees. The amount shall be refund to the non-selected applicants and selected applicants after the training programme. Fees shall not be refunded to the candidate who have confirmed their participation and not attending the programme for the entire duration of the workshop. Processing fees of about 2.6% shall be deducted while refunding the commitment fees to the applicants.

Suitable candidates shall be selected based on eligibility criteria and merit of their application by Selection Committee. Applications found to be incomplete, ineligible and redundant shall not be shortlisted for training. Candidates shall be informed of their selection or non-selection by email. Selected participants shall confirm their participant to BCIL immediately on receipt of email by BCIL. In case the selected candidate shall be unavailable to attend the programme after confirmation, he/she shall inform BCIL immediately. Selected candidates cannot nominate another colleague/friend from their organization.

For the out-station participants, accommodation on twin sharing basis and hospitality arrangements shall be made available for the duration of the programme by CDSA, Faridabad. Conveyance shall be provided from the accommodation facility to the programme venue by CDSA, Faridabad. Accommodation arrangements shall be made available only for those participants who place a request for it in the application form. Please note that the participant shall make his/her own travel arrangements to reach the venue of the workshop/accommodation from railway station/airport. No travel allowance shall be given to the participants.

Participants shall have to attend the full 2 - day programme. Attendance shall be compulsory for each day of the programme. Certificate of participation shall be awarded to the participants on successful completing the entire duration of the training programme.

You may kindly contact nbmworkshop@biotech.co.in or 011-23219064-67 for any further queries regarding the programme.