cGMP AUDITS AND COMPLIANCE How to conduct and face National & International Audits

Course Description


How to conduct and face National & International Audits Achieving Quality & Compliance Excellence in Pharma Industries

Why choose training from the US? Workshop outcome.
Departments to benefit from the training
Level of participation:
Your organization's non-conformances need to be addressed quickly and systematically. That is why you need to ensure your management systems are equipped to document non-conformities efficiently, enabling you to tackle the issue as effectively as possible. Our CAPA process training will provide you with the knowledge you need to ensure that your organization conducts proper containment, correction and preventive actions.

By the end of this one-day course you should be able to:
? Determine non-conformances more effectively
? Understand how to complete a containment and correction plan
? Identify and differentiate the root cause of any non- conformity
? Ensure immediate, preventive response and verification-in line with all requirements
? Verify the completion of any action taken
? Carry out a follow-up to show the effectiveness of corrective and preventive action plans
In all aspects of good manufacturing practice (GMP) PQS systems, we possess un-equaled experience and expertise of the CAPA process. As a result, we can provide you with CAPA training that boost a unique perspective and level of insight. By the end of this workshop, each participant will Get complete CAPA requirements for all GMP international/ National regulatory/ Client/ other regulatory
This course is designed for all personnel involved in cGMP QMS Deviation/OOS/Market complaint
Management and CAPA activities at their company and decision makers who want to improve the existing process. It is addressed to persons from Quality Assurance and Control, Manufacturing and R&D, Engineering and Stores
1. Jr/Sr QA/QC staff executives, Chemists, Officers
2. Manager level
4. Department heads
5. CQA- Corporate Quality Assurance
6. Audits and Compliance Departments.
For In-house training contact us on 022-30210100 or email

Training Agenda

Day- One

1. How to address Audit notice, and How to face Audit
-Discussion about introduction of respective regulatory inspection
- How to write welcome letter with supporting documents
- KEY Documents requirements
- How to face Audit and its readiness-How to face audits- National, International regulatory Audits and Customer, Internal audits.
-A motivation presentation and how to face, what to answer etc.
2. Fundamentals of Global cGMP Requirements- Trends in cGMP Compliance
- cGMP Key requirements in USFDA and EU
- Inspections Requirements in USFDA/ EU/ TGA/ MCC/ Health Canada/ WHO Geneva/ PIC(s) and ROW
3. Triggering of CAPA from Audit observations
- How Audit observations to be recorded
- How to document CAPA on audit observations
- CAPA format
4. How to implement effective CAPA Systems- Effective CAPA Management for Optimal Compliance
- How to implement effective CAPA
- Effectiveness Verification of CAPA
- How to assess and to document Effectiveness verification
- What questions to be evaluated during effectiveness verification of CAPA
5. Laboratory Compliance –Recent audit observations and its CAPA
- Recent Critical USFDA Laboratory QMS observations
- Recent critical EU laboratory audit observations
- How to rectify and effective CAPA on these observations
6. CAPA- Failure Investigation and Root cause analysis
- How to conduct failure Investigation on OOS, Deviations, Market complaint, Laboratory incident, Event failures and its Root cause analysis
- CAPA on failure investigations
Day- Two

7. Compliance Aspects of APIs Manufacturing
- USFDA/ EU requirements on API GMP Compliance
8. Compliance Aspects of Formulations
- USFDA/ EU requirements on Formulation GMP Compliance
9. Compliance Aspects of Laboratory Quality systems.
- USFDA/EU requirements on laboratory Quality systems Compliance
10. Compliance Aspects of Sterile Manufacturing
- Key Compliance requirements on sterile manufacturing
11. CAPA- Closure
- How to close Audit-related CAPA
12. Spotting Overall Weak GMP Compliance Systems
- Discussion on Current weakness in industry-
- How to avoid weakness
13. Avoiding FDA Enforcement Actions: An Optimal and Sustainable Compliance Program
- How to implement robust Quality system to achieve 
- Optimal and Sustainable Compliance Program
14. Behavioural GMPS (bGxP®): A New Paradigm in Compliance Management
- How to bring Compliance-cGMP environment
- Human behavior issues and salvation techniques
- How to bring ethical cGMP compliance
Practical Workshop:
1. How to address CAPA for Recent USFDA warning letters/EU Non-compliance observations
Q&A- Discussion section
1. Answers to all attendees questions
2. Regulatory Audits – Quality issues through case studies
For In-house training contact us on 022-30210100 or email

Course Director

He has developed a profile as a quality practitioner in the field of Quality Assurance, Quality Control, Bioequivalence, and Pharmaceutical Regulations. Quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies, and CRO. Main areas of expertise covers Total Quality Systems as per cGMP, GLP, GCP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA, Japan guidelines Having competent QA/ QC knowledge in API and formulation field of USFDA; cGMP, ICH Q8, Q9, Q10, Q7, EMEA, cGMP, MHRA Orange Guide and OECD GLP guidelines. Having a strong background on regulatory guidelines for DMF, CTD Documents (ICH M 4 Q), ANDA and BA/ BE Computer Systems and Software Validation, 21 CFR scope, Equipment Validation (DQ/ IQ/ OQ/ PQ), analytical and bioanalytical method validation, process validation (Prospective, Retrospective and Concurrent) preparation BMR, MFR, Validation Master Plan, Site Master File, Training Schedule, Quality Manual, analytical worksheet preparations, impurity profiling, stability studies (for Both Drug Substance and Drug Product), OOS, OOC, other deviations and change controls. Got a very good working knowledge of ISO 9001:2000 (QMS), EHS system and ISO 14001:2005. Undergone through regulatory Audits like USFDA, MHRA, WHO, DCGIINDIA, TGA and EMEA, MHRA and prepared documents and SOPs for above- mentioned regulatory bodies and for ANVISA Brazil. Additionally experience in Auditing Bio-Equivalence studies and Clinical Trials Phase I-IV. Maintains Total Quality Management Systems as per cGMP, GLP, GCP and EMEA, USFDA, MHRA and MCC, Japan GUIDELINES and Conducting of Computer Systems and Software Validations. Having the competent QA/QC knowledge in API and Formulation Field. • USFDA GMP AUDIT faced and achieved Zero 483. • USFDA GLP AUDIT for Bio-analytical laboratory-Audit passed with minimum observations • USFDA Bioequivalence Audit – Surprise unannounced Inspection Zero 483
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