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Advance GMP Training modules

Home Advance GMP Training modules

For the GMP core group of the firm comprising of cross-functional teams from different sections.
These modules undergo periodic changes. For current contents and detail, please write to us.

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Good documentation and Record Management Practices - (Duration : Two days)
  • Understanding documentation and its importance & reasons for requirement of GMP documentation.
  • International GMP requirements ( regulations and guidelines ) on documentation to cover US FDA, EU, WHO and relevant updates.
  • Documentation systems for performance & compliance.
  • The Documentation Cycle : Conception to Retention.
  • Departmental documentation : Where do we go wrong.
  • The Time saving tips for sustained regulatory performance and compliance.
  • Designing, writing and checking of SOP's : Emphasis on the SOP for SOP and working aspects of documentation.
  • The Do's and don'ts of GMP documentation.
  • Managing hard and soft copies of documents.
  • GMP documents as Spec's, MFR, BMR, Engg.
  • Documents, Labels and Good Labelling Practices.
  • Document Change Control and Facing Documentation audits : Documents that are audited & auditors favourite SOPs.
  • Facing GMP audits on documentation successfully.
  • Maintaining consistency through effective documentation - Principles and Practices.
  • Maintaining the GMP continuum.
Training the gmp trainer to train effectively (a certified trainers course)
Duration : Three days
  • What is training and development – difference in the same.
  • Focus and goals of training and development – why qualified trainers are essential.
  • International GMP requirements on Personnel & GMP Training – US FDA, WHO, EU and ICH Q7 – guidelines and regulations world over in the area of training.
  • The importance and benefits of training and development – individual development for institutional development.
  • Principles of adult learning, type of learners, stages of learning, what motivates adult learners, rules and laws of adult learning, the science of andragogy and sustenance of learning.
  • Developing a Result Oriented training system, making it work for you.
  • Identifying key result areas / priorities in terms of GMP Training.
  • Training employees to match individual competencies with organizational expectations.
  • Focal steps in training - Training need identification, scheduling, planning, qualifying trainers, budgeting, executing, evaluating, maintaining and documenting training activities.
  • Use of quality risk management tools in the training system; setting meaningful training frequencies.
  • Know your audience – planning training, handling varied participants.
  • Presentation skills and techniques.
  • Preparing training aides ( visuals, handouts and other supports ).
  • Qualities of good trainers and bad trainer traits.
  • The do’s and don’ts for trainers.
  • Training evaluation & audits.
  • Audit and auditors expectation, system & documentation.
  • Maintaining training continuum.

  All the participants get a practice presentation session, which is evaluated by the faculty, and improvements are suggested. The qualified members receive a certificate as in-house trainers, which are accepted by international authorities.

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Validation : getting the basics right
Duration : two / three days
  • Validation; historical aspects purpose and scope
  • Understanding commonly used terms in validation
  • Planning and organizing for validation : timelines
  • The phases and types of validation
  • Prospective, concurrent, retrospective validation
  • The qualification exercise : URS and Risk analysis
  • DQ / IQ / OQ / PQ / PV
  • The validation Documentation Grid : VMP, Core SOPs, Protocols, Reports and summary reports
  • Preparing for validation, setting teams and priorities
  • Addressing validation failures and revalidation
  • Deviation, change control, calibration, maintenance
  • Maintaining the validated state through effective use of above tools
  • Facing validation audits and auditors expectations
  • Non compliance reported and corrective actions
Validation Answers to the advances - new US FDA and EU Validation requirements
Duration : two days
  • Validation definition, historical aspects current regulations, guidance and application of US & EU
  • Frequently used terms in qualification and validation, understanding the new principles and practices
  • New stages I - III in validation - the traditional 4Q approach versus the current requirements - normative references to ASTM C&Q guide- E 2500 - 07 and PAT
  • Criticalities of process design and development pre-requisites - design space definition and understanding
  • Life cycle approach to process validation and relationship with QbD, QRM PQS and PQR ( APR )
  • Applications of quality risk management during validation life cycle, design to verification
  • The process performance qualification ( PPQ ) approach to include facilities, utilities and equipment
  • The requirements and importance of validation monitoring activities - continues process verification
  • Important aspects of SPC in relation ship with continued process verification
  • Validation documentation - balancing conventional and current requirements
  • Thrust areas and the way ahead for implementation
  • Overcoming non-compliances to maintain the validation continuum
Conducting GMP audits effectively ( Auditors Qualification Course )
Duration : two days
  • Definition, purpose, benefits, system, and Regulations for Self-inspection and Internal Audits.
  • Scope of internal audits and audit types – first, second and third party audits, three tier audits.
  • Auditing styles, frequency, plans and programmes.
  • SOP's, staffing and training requirements.
  • Auditing tools and techniques ( checklists, meetings, discussions and likes ).
  • Steps in vendor auditing.
  • Remote audits and GMP approach.
  • Auditing and Quality Risk management ( QRM ), - a risk based approach to GMP auditing ( Reference : PICS and other agencies ).
  • Skills and proficiencies required for internal auditors with emphasis on oral, non-verbal ( kinesics and proxemics ) and written communication skills.
  • Audit documentation from beginning to end.
  • Use of checklists and other auditing tools.
  • Interviewing auditees - high gain questioning, body language, collecting, analysing, interpreting data ( questioning skills ).
  • Writing effective / directive audit reports, follow-ups and monitoring compliance.
  • Frequently reported Non compliances in internal audit systems.
  • Maintaining the GMP continuum.

  A certificate is awarded to each qualified auditor successfully completing this course. This meets the GMP requirements that internal audits, self-inspections should be conducted by qualified auditors.

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Cleanroom principles and practices
Target group - officers and above working in different sections
Duration : two days
  • what are clean rooms, history and evolution standards for classification
  • critical aspects of cleanroom elements - containment strategy
  • Entry to and exit from cleanrooms
  • Gowning - laundry management, sops, qualification, maintenance of cleanrooms
  • Dos and donts for the cleanroom
  • Behaviour in cleanrooms - how cleanrooms are contaminated by personnel
  • Cleanroom control, good aspetic practice and risk assessment
  • Cleaning and disinfection of cleanrooms - preferred agents, concentration, preparation, application and validation
  • Monitoring of cleanrooms
  • Good engineering practice for cleanroom maintenance personnel
  • Sustainable compliance and performance intiatives to maintain the GMP continuum
Cleaning Validation – a scientific and sensible approach
Duration : two days
  • History, evolution and concepts of cleaning validation.
  • Regulations, Guidelines and Guidance on cleaning validation.
  • Current trends and changes; objectives of cleaning validation.
  • Types of cleaning - Manual, CIP, WIP, COP and SIP requirements.
  • The concepts of TACT, DEHT, CEHT and SDT.
  • Criteria ,choice and risk in the selection of cleaning agents.
  • Planning and executing cleaning validation studies, plans.
  • Contents of cleaning SOP and cleaning validation protocols.
  • Defining and setting acceptance criteria and residue limits.
  • Visual, chemical and microbiological specifications.
  • Sampling types ( rinse, swab, coupons, swatch, placebo ) – merits & demerits of each techniques and relationship with recovery studies.
  • Residue calculations- chemical & micro ( Dose, MACO, Toxicity ).
  • Risk assessment : use of QRM tools as FTA, FMEA, FMECA, HAZOP, HACCP & PHA with references to PAT, Q8, US FDA new PV guide R1.
  • Training and qualification requirements of personnel in CV.
  • Change control and revalidation of cleaning; Variants to cleaning techniques and challenges in maintaining the validation status.
  • Non compliances reported by international regulatory agencies in various aspects of cleaning validation.
  • Maintaining the cleaning validation and GMP continuum.
Deviation Management, CAPA & Change Control
Target group - officers and above working in different sections
Duration : two days
  • Aspects of GMP & Quality in relationship with review & disposition of deviations, CAPA & Change control in line with Pharmaceutical Quality Systems ( PQS – ICH Q10 ).
  • The objectives, scope of deviation, CAPA & Change control; Deviation & Change, the differences.
  • Deviation types : Systems and procedural steps from initiation to closure and monitoring trends during Periodic Quality Reviews ( PQR ); Using Risk management principles.
  • Human Error Assessment & Reduction Techniques ( HEART ).
  • CAPA - introduction, definitions, applications, the aspects of correction, corrective action and preventive action; seven steps of CAPA, procedural description, failure investigations & root cause analysis. Impact evaluation & QS linkages of CAPA systems with QMS ( References to ICH Q9 & Q10 ).
  • Inspectional observations of EU, US FDA & other Regulators on deviation management & CAPA systems.
  • Change control types, process & system, steps and impact evaluation including Quality Risk Management ( QRM ).
  • Relevant documentation; frequently referred SOPs during Change Control; the relationship with validation status Brief overview of the SUPAC AND BACPAC guidelines.
  • References to change control in international guidelines and regulatory inspectional observations.
  • Contents of SOP, forms and logs for the above systems.
  • Linkages with systems like APQR and commitment tracking.
Quality Risk Management ( QRM ) - a risk based approach to GMPs
Duration : two days
  • Understanding RISK – what constitutes risk to quality & GMP.
  • Regulatory aspects and background of risk assessment and management, the 21st Century GMPs of US FDA, ICH Q9 and EU GMP part III, PICS and WHO QRM guide/s ( updates until Sept 2012 ).
  • Applications of quality risk management, specific cases.
  • Tools used in quality risk management:
    • Risk Ranking ( Low, Medium, High ) and filtering
    • Fault Tree Analysis ( FTA )
    • Failure Mode Effect Analysis ( FMEA ) and Risk Probability Number ( RPN ) and risk decisions; ( more emphasis shall be provided on this tool )
    • Failure Mode Effect Criticality Analysis ( FMECA)
    • Hazard Analysis Critical Control Points ( HACCP )
    • Hazard Operability Analysis ( HAZOP )
    • Preliminary Hazard Analysis ( PHA )
    • Overview of tools as histograms, scatter plots, pareto charts, cause and effect diagrams, DOE and likes
  • Use of risk based approach during qualification, validation, deviation management, change control and APR (PQR).
  • Audit expectations and non compliances reported so far in the area of QRM.
  • Maintaining the GMP continuum using a RBA.
Resolving DATA INTEGRITY Issues and Facing UNANNOUNCED GMP Inspections Successfully
Duration : two days
  • Data integrity : concept and importance.
  • Problems related to data integrity : origin and solutions.
  • Regulatory requirements of data integrity.
  • The ALCOA principle and ALCOA + ( US FDA and MHRA ).
  • Analysis of recent warning letters issued to Indian firms on data integrity and case studies.
  • Building the concepts of data integrity into pharmaceutical quality systems to avoid potential pitfalls.
  • Integral behavior and attitude in tandem towards data integrity.
  • Unannounced inspections systems, requirements and process.
  • Understanding investigator needs, necessities and expectations ; how cultural differences affect.
  • Remaining in the state of perpetual inspection preparedness and readiness.
  • Handling documentation requests during the inspection timely and effectively.
  • Face to face with the investigator : taking questions, providing apt answers and the body language syndrome.
  • Do & Don'ts and strategies for success.
  • Maintaining the performance and compliance continuum.
Data integrity for compliance and performance
Duration : One day
  • Data integrity : concept and importance.
  • Problems related to data integrity : origin and solutions.
  • Regulatory requirements of data integrity for all types of data and its management.
  • The ALCOA principle of US FDA and ALCOA+ of MHRA.
  • Planning and implementing these principles into practice.
  • Analysis of recent warning letters issued to Indian firms on data integrity and case studies.
  • The regulatory opinion and expectations.
  • Common pitfalls and risk mitigation strategies.
  • Understanding common problems of data integrity and possible solutions to overcome them.
  • Building the concepts of data integrity into pharmaceutical quality systems to avoid potential pitfalls.
  • Maintaining the continuum.
Equipment qualification - from clarity to continuum
Duration : Two days
  • What is qualification.
  • Differences between qualification and validation.
  • Frequently used terms in qualification.
  • GMP requirements detailed in WHO, EU annex 15 ( old and revised ) and PICS.
  • Structure of validation master plan, site validation master plan, validation plan w.r.t. qualification activities.
  • The equipment procurement model and sequence of qualification activities from URS to PQ.
  • Comparison of GAMP 5 V model and ASTM E 2500/07 models of qualification.
  • Qualification of facility, utilities and equipment.
  • Contents of URS, FS, TS, DQ, IQ, OQ and PQ Protocols.
  • The new IOQ or OPQ approach.
  • Sequential steps in qualification activities from DQ to PQ.
  • A risk based approach to qualification - system and component impact assessment.
  • Data management and change control.
  • Qualification documentation - core sops, protocol structure, qualification reports and linkages with PQR ( APR ).
  • Handling qualification failures.
  • Commonly faced qualification problems and commonly reported non compliances.
  • Tools to maintain the qualification status.
Good Engineering Practices ( GEP )
Duration : One day
  • What is GEP and its relevance and relationship with GMP.
  • Important aspects of GEP.
  • Planning for execution and application of GEP principles in GMP impacting operations.
  • Impact assessment, grading of critical, direct and indirect impact systems.
  • Role of GEP in qualification and validation and outsourced activities.
  • Importance of maintenance in line with GEP and a risk based approach.
  • Types of maintenance and handling deviations and changes through pharmaceutical quality systems.
  • GMP documentation for GEP.
  • Spare control and management – engineering services workshop controls.
  • Elaborations on GMP impacting engineering controls.
  • What do GMP auditors look for in GEP aspects.
  • Non compliances reported.
  • Sustainable compliance initiatives thru GEP.
GMP for torch bearers Level 1
Duration : One day | ( a unique training programme for senior management )
  • The new paradigm of GMP – Moving from assurance to systems.
  • GMP updates that matter to the senior management.
  • PQLI – Pharmaceutical Quality Life-cycle Implementation.
  • Expectations of regulatory agencies from the TMT ( Top Management Team ).
  • Designing and maintaining the state of control.
  • Importance of management review in an GMP environment – the three tier expectations.
  • Maintaining the GMP continuum.
GMP for torch bearers Level II
Duration : One day | ( a unique training programme for senior management )
  • GMP update : summary of current changes to GMPs - that matter to the senior management.
  • Leadership qualities essential to plan and implement quality and GMP requirements.
  • Coping up with newer management responsibilities towards GMP and quality.
  • Value creation and addition – new projects and customer interfaces.
  • Sustaining the 3E effect – Enable, Encourage, Enthuse.
  • Time Management.
  • Goal congruence.
  • Maintaining the GMP continuum.
Current Regulatory Trends and Changes
Duration : Two days

Changes to the GMP Regulations and Guidelines of the following regulatory agencies during the last decade till date.

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  • United States Food And Drug Administration ( US FDA )
  • World Health Organisation ( WHO )
  • European Union ( EU )
  • Specific ( Other than European Union ) Changes to Medicines and Healthcare Products Regulatory Agency UK & Therapeutic Goods Administration, Australia ( MHRA & TGA )
  • GMP Guide and Checklists of Pharmaceutical Inspectors Cooperation Scheme ( PICS )
  • Medicines Control Council ( MCC ), SA
  • International Conference On Harmonization ( ICH ) [Q7-Q11]
  • Health Products Food Branch Inspectorate ( HPFBI ), Canada
  • Schedule M & L1 on GMP & GLP India, GDP, Recall
  • GMP in the Near Future - What's Happening with all the Regulatory Agencies and Pathway for the Future
Effective Deviation Investigation and Report Writing
Duration : Two days
  • What do the terms deviation, failures, changes and CAPA mean and the interlinking risk based approach
  • Regulatory requirements for the above three GMP drivers
  • Steps in deviation management and failure investigations - chronological expectations and flow path
  • Importance of investigation, developing investigation and reporting skills for performance and compliance
  • Logical steps in investigation to determine RCA and when most probable and non assignable cause/s is an acceptable outcome
  • Beyond Human Error and Retraining as CAPA
  • Investigative Tools and techniques as brain storming, FTA, Cause and Effect diagrams, 5 Why analysis and HAZOP
  • The true attributes of human error – types, reasons and the control aspects
  • Human error assessment and reduction techniques
  • Findings, observations and writing correct investigation reports – combination of substance and style
  • Expectations, requirements and responsibilities of investigators, reviewers and approvers of investigation reports – avoiding recurrent trends
  • Language proficiency, reasoning, coherence, structure, grammar to write meaningful investigation reports
  • Requirements of style and substance for investigation reports – the do's and don'ts of report writing
  • Common problems and possible solutions in rendering the investigation system effective
  • Non compliances reported by various regulatory agencies in investigation and its documentation

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